API Services & Chemical Development Archives - Almac

Almac Sciences Launches New cGMP Flow Hydrogenation Capability

chloefinch — Fri, 13 Mar 2026 10:09:16 +0000

The company’s latest flow chemistry investment strengthens continuous processing offering for clinical and commercial manufacturing programs

Almac Sciences, a member of the Almac Group, is pleased to announce a significant expansion of its API and flow chemistry services with the launch of cGMP compliant flow high pressure hydrogenation. This new capability brings enhanced precision, safety, and scalability to one of the most critical transformations in modern synthetic chemistry and is now available for both clinical and commercial manufacturing programs.

Hydrogenation is an essential step across many synthetic routes and performing it under continuous flow conditions offers transformative benefits. Flow operation provides superior control over temperature, pressure, and mixing, enabling improved reaction performance, reduced impurity formation, and reliable reproducibility at scale. By integrating this technology under cGMP conditions, Almac Sciences now gives clients access to faster, safer, and more efficient hydrogenation up to 100 Bar pressure and 300 deg C with the confidence of full regulatory compliance and rigorous analytical oversight.

This advancement builds on over eight years of substantial investment in flow chemistry, during which Almac Sciences has developed deep expertise in packed-bed hydrogenation and demonstrated robust performance at scales exceeding 100 kg. The addition of cGMP capability further strengthens Almac’s position as a leading provider of manufacturing solutions.

“This investment marks a significant milestone for our team and our clients,” said Dr. Scott Wharry, Associate Director of Custom and Flow Chemistry at Almac Sciences. “By combining cGMP flow hydrogenation with our established expertise in cryogenic organometallic chemistry and large scale packed-bed hydrogenation, we are offering continuous processing capability today. These technologies not only improve safety and efficiency but also align with the industry’s drive toward sustainability and innovation.”

With this latest investment, Almac Sciences continues to expand its comprehensive continuous flow offering, providing global partners with cutting-edge technologies backed by the company’s multidisciplinary team of chemists, engineers, analysts, automation specialists, and project managers. This integrated expertise ensures clients receive not only technical excellence but also strategic guidance and support at every stage of their molecule’s journey.

Prof. Tom Moody, VP API Development and Commercialisation, added: “Flow hydrogenation under cGMP is a major step forward for our customers. It delivers enhanced process confidence, consistent high quality output, and exceptional scalability, all while reducing environmental impact and operational risk. As the industry increasingly prioritises safer, greener, and more flexible manufacturing solutions, this capability reinforces our commitment to supporting clients from early development right through to commercialisation.”

Find out more about our Flow Chemistry Capabilities

The post Almac Sciences Launches New cGMP Flow Hydrogenation Capability appeared first on Almac.

Almac invests £500,000 in state-of-the-art instrumentation within spectroscopy laboratories

brendanhagan — Fri, 17 Jan 2025 11:02:40 +0000

Almac Sciences, a member of the Almac Group, has invested £500,000 in state-of-the-art instrumentation within its spectroscopy laboratories at its global headquarters in Craigavon, Northern Ireland.

Almac is committed to providing the best analytical facilities for its customers and the recent purchase of the new Agilent 6545XT AdvanceBio Q-TOF Mass Spectrometer and a Malvern Panalytical Empyrean X-Ray Powder Diffractometer supports this goal.

This latest investment is additional to the company’s announcement in October 2024 of an £11million spend to expand Almac’s global analytical services capabilities, which includes the creation of 100 jobs.

The Craigavon laboratories house state-of-the-art Mass Spectrometers, X-Ray Powder Diffractometers as well as Nuclear Magnetic Resonance Spectrometers. These investments substantially increase the company’s capabilities in solving complex analytical challenges and provide additional security for urgent analyses, additional processing capabilities, and superior data integrity controls to ensure increasing regulatory compliance needs are met.

Within the dedicated facility, equipped with advanced LC-MS, GC-MS, ICP-MS, XRPD and NMR instrumentation, clients can benefit from a range of spectrometry services, including the quantitation of genotoxic impurities, trace elemental analysis, isotopic purity determinations, structure elucidation, analysis of peptides, proteins, glycoproteins and antibody products as well as polymorph screening, confirmation and quantitation of crystalline phases.

Dr John Malone, Associate Director of Spectroscopy, Almac Sciences said: “The continued investment and growth in our spectroscopy laboratories underlines Almac’s commitment to providing the best analytical facilities for its customers, and seamlessly meeting their needs.  We are delighted to offer our clients cutting-edge technology that supports their product safety imperative and accelerates the drug development cycle.”

Dr Darren Thomas, Vice President of Analytical Operations commented: “As we continue to enhance our analytical capabilities, our commitment to excellence remains unwavering. This substantial investment in cutting-edge technology emphasises our dedication to offering comprehensive analytical solutions to clients around the world.”

The post Almac invests £500,000 in state-of-the-art instrumentation within spectroscopy laboratories appeared first on Almac.

Almac chemist recognised as “Future Leader” at CPHI Celebration Awards 2024

thomasdrake — Wed, 09 Oct 2024 07:11:24 +0000

Dr Megan Smyth wins award for rising stars bringing fresh approaches in the pharma industry

Almac Sciences, a member of the Almac Group, is delighted to announce Dr Megan Smyth, Senior Team Leader, Custom & Flow Chemistry, has been recognised with the Future Leader award at the 2024 CPHI Celebration Awards.

The inaugural award, announced at The CPHI Celebration ceremony in Milan last night, recognises pharma leaders of the future who are bringing a fresh approach to the industry via evidence-based examples of leadership & collaboration, external recognition, personal brand and industry involvement. For more than 20 years, the CPHI Pharma Awards have celebrated innovators making a difference – individuals, teams and companies who are breaking new ground and driving the industry forward.

Megan’s success was demonstrated through her role as Senior Team Leader within Almac Sciences’ Custom & Flow Chemistry team, where she has shown strategic leadership in the further development of Almac’s flow chemistry capabilities, including the establishment of a commercially viable manufacturing platform. Over the past five years, Megan has been an integral part of Almac’s flow team, generating revenue to meet ambitious growth targets, thus adding significant value to Almac’s business. The judges noted that Megan stood out as an emerging talent who had demonstrated the introduction of new ideas, inspired her colleagues and contributed to the broader industry through collaborations, conferences and scientific journals.

In 2022, Megan also won a highly competitive UK Research and Innovation (UKRI) Future Leaders Fellowship (FLF). The R&D grant, worth £1.5 million, funded over a 4-year period, has been enabling further enhancement of innovative continuous manufacturing.

Megan commented: “I am thrilled to receive this inaugural Future Leader award from CPHI. To be globally recognised for my contributions to the pharmaceutical industry as a Future Leader is a huge honour. The implementation of flow chemistry continues to be hugely impactful within the pharmaceutical industry and I am excited to see what the future brings for me, my team and Almac Sciences.”

Prof Tom Moody VP Technology Development & Commercialisation added “Congratulations to Megan for winning this award. Megan is the most worthy recipient and has been instrumental to the growth of our flow chemistry expertise. A Future Leader award is a well deserved merit for all of her achievements to date and I wish her continued success at Almac.”

Visit Almac at CPHI Milan from 8 – 10 October at stand 7C2.

The post Almac chemist recognised as “Future Leader” at CPHI Celebration Awards 2024 appeared first on Almac.

Almac Group announces £11m investment to expand global analytical services

evewallace — Tue, 01 Oct 2024 08:00:00 +0000

Almac Group, the global contract development and manufacturing organisation (CDMO), has today announced an £11m investment and the creation of over 100 new jobs to expand global analytical services capabilities.

Over the past 18 months, Almac Sciences, which provides development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API), and Almac Pharma Services, which specialises in pharmaceutical drug product development, manufacture and commercial services, have jointly made this significant investment to expand their existing analytical laboratories, technology and resource to meet ongoing global demand.

Almac employs over 700 highly skilled analysts working in regulatory approved GMP laboratories across five locations in Craigavon, UK; Charnwood, UK; Souderton, Pennsylvania; Athlone, Ireland and Dundalk, Ireland. Construction of new laboratory space at the company’s global HQ site in Craigavon considerably increases overall capacity, whilst additional upgrades and development of existing labs across all sites means Almac will seek to increase its existing global analytical employee headcount by over 100 in the next 12 months.

With more than 55 years’ experience, Almac supports drug substance and drug product analytics across all phases, from early phase pre-clinical / clinical development to commercial release. The company typically develops over 1,000 analytical methods and validates over 250 analytical methods each year. Their expert teams offer a comprehensive end-to-end suite of analytical testing for a range of product types including small molecules, peptide, biologics, conjugates, potent and controlled substances.

Almac has added a significant number of specialised instrumentation and techniques across several service lines including chromatography, spectroscopy and biologics. The recent introduction of the Raman TRS100 system also offers clients a faster array of tablets, capsules and other dosage forms. Additional investment in physical sciences equipment (XRPD, PSD, TGA and DSC) provides enhanced capability to support the company’s new spray drying offering from its Charnwood site.

A multi-million-pound digitisation upgrade across all sites, including further investment in Almac’s existing laboratory information management system (LIMS), highlights the company’s ability to seamlessly share information across multiple teams, departments and facilities offering clients a reliable, optimised and streamlined solution.

As part of its ongoing outreach programme, Almac has invested heavily in continuous training and development of its analytical experts. The teams also work closely with local academia to promote and develop a pipeline of talent by providing apprenticeship placements throughout the year.

Darren Thomas, Vice President Analytical Operations, Almac Sciences, commented: “We have experienced a significant increase in demand for our dedicated analytical solutions and recognise the importance of continually investing, not just in our systems and facilities, but also in our people. We are committed to offering a best-in-class service to our global client base and are delighted to continue at pace with significant investment across our UK, EU and US facilities in order to strengthen our competitive position in the marketplace.”

Trevor Clarke, Vice President Analytical Operations, Almac Pharma Services added: “We are positioned as the partner of choice with significant experience in a wide range of analytical services to meet the varying requirements of our clients’ unique development and commercial programs. As we continue to expand our global analytical capabilities, we remain committed to delivering excellence. This significant investment in innovative technology, skilled talent, and state-of-the-art laboratories underscores our dedication to providing comprehensive analytical solutions for our clients worldwide.”

Today’s announcement is part of Almac Group’s £400 million investment to ensure Almac remains global leaders in the industry, giving clients, and ultimately patients across the world who benefit from these therapies, the best possible range of solutions.

The post Almac Group announces £11m investment to expand global analytical services appeared first on Almac.

Arran Chemical Company celebrates 40 successful years in business

brendanhagan — Tue, 24 Sep 2024 08:00:00 +0000

Twenty-million-euro investment by Almac Group trebles chemical company’s revenues and innovative services

Arran Chemical Company (Arran), a member of the Almac Group, is celebrating 40 years in operation.

Originally founded in 1984 by Dr Anthony Owens, Almac acquired the company in 2015 to combine its biocatalysis and flow chemistry expertise with Arran’s large scale manufacturing capacity to improve production processes while enhancing sustainability.

Arran has grown significantly under Almac’s ownership – having invested over €20 million to date, revenues have more than trebled and employee numbers have grown from 45 to 125 people. Further planned facility and capacity expansions will support growth and meet future client demands.

Arran is a named manufacturer of key building blocks that go into over 30 different commercial drugs ranging from products that are used to treat hypertension, cardiovascular issues, renal problems and epilepsy among others. As well as life-changing pharmaceutical products, Arran manufactures aroma chemicals for the fragrances industry used in high-end perfumes and personal performance applications. Arran also manufactures a range of fine chemicals used by the contact lens sector.

Dr. Stephen Barr, President and Managing Director of Almac Sciences said: “We are delighted Arran has reached this operational milestone and are proud of our global reputation for excellence built over these 40 years.

“Our success and ability to provide first class service has only been made possible by the dedication of our exceptional employees, and we pay tribute to their work as we reflect on this milestone. As we look to an exciting future, we wish to thank everyone who has played their part in our story so far. So, to our employees, clients, suppliers and other key stakeholders, thank you.”

Professor Tom Moody, VP Technology Development and Commercialisation for Arran added: “Arran has engaged and thrived in chemical manufacturing for 40 years and continues to innovate in this space through the development of new technologies and subsequent deployment at production scale.

“Almac’s continued investment has allowed us to future-proof the business and we are excited about the years to come. I also echo my thanks to our great team in Athlone, our clients and key stakeholders. We look forward to reaching new milestones and making further advancements across the business.”

The post Arran Chemical Company celebrates 40 successful years in business appeared first on Almac.

Almac Sciences awarded Life Sciences Innovative Manufacturing Fund Grant

brendanhagan — Thu, 14 Mar 2024 09:00:00 +0000

Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant

Almac Sciences, a member of the Almac Group, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of its small molecule active pharmaceutical ingredients (API) manufacturing facility at its Global Headquarters in Craigavon, UK.

The grant will support the installation of the expanded facility, already under construction, which is due for completion in Summer 2025. Once complete, the 30,000 sq ft facility will support small molecule API production at 100s kg to metric tonne scale.

As announced by Jeremy Hunt, UK Chancellor, Almac was one of two UK pharmaceutical companies awarded the grant to support manufacturing expansion projects. The Department for Science Innovation and Technology (DSIT) reopened the LSIMF in 2023 to support businesses investing in manufacturing projects in the UK. Over its lifetime, the fund will provide capital grants for investments in the manufacture of human medicines (drug substance and drug product), medical diagnostics and MedTech products.

Almac Sciences has grown rapidly over the last five years and this expansion is part of a multi-million-pound investment programme to support increased client manufacturing demands. The first stage of Almac’s GMP facility expansion was announced late 2022 with an extension to its current GMP manufacturing facility, and warehouse expansion opened Summer 2023. Increased capacity for peptide API production has just been announced, creating another manufacturing centre of excellence and further supporting the business’ ongoing growth plans.

Dr Daniel Bayston, VP Small Molecule API, said: “As a privately-owned and independent company, we are committed to re-investing all our profit back into the business, allowing us to continuously innovate and expand. We are delighted and grateful to be awarded this grant, assisting us with our ongoing expansion plans.

“Almac has a strong, global reputation, built over the last 55 years as a trusted and stable CDMO partner for the world’s leading biopharma companies. This new manufacturing facility is critical to support the increased demand from our clients and provides us with a stronger ability to serve our global customer base advancing human health.”

Almac has a proven track record and expertise in small molecule and peptide API manufacturing from pre-clinical to commercial scale and has developed long-established relationships from pharma and biotech clients offering comprehensive end-to-end development and manufacturing solutions.

The post Almac Sciences awarded Life Sciences Innovative Manufacturing Fund Grant appeared first on Almac.

Almac Group Awarded six 2024 CDMO Leadership Awards

brendanhagan — Tue, 12 Mar 2024 14:30:00 +0000

Almac Group, the global contract development and manufacturing organisation, is delighted to announce that the Group’s Pharma Services and Sciences divisions have, once again, been recognised in all six core categories in this year’s CDMO Leadership Awards programme.

The annual award programme, presented by Outsourced Pharma and Life Science Leader, recognises top performing CDMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. Results are based solely on primary market research by Industry Standard Research (ISR), with winners in each category judged by their customers as either exceeding expectations or as top performers in outsourced projects conducted within the past 18 months.

Almac holds an exceptional record of client service, further underscored by the CDMO Leadership Awards programme and its primary research-driven methodology. The company is a privately owned and independent CDMO that has grown organically for over five decades, now employing over 7,200 and undergoing significant expansion in capacity and technology exceeding £400 million across the globe.

This year, 98 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. This experiential feedback was analysed by sponsor company size to reveal leading CDMOs in different performance categories.

Almac was successful in achieving awards in all core categories including:

Capabilities (Small Pharma)
Compatibility (Small Pharma)
Expertise (Small Pharma)
Quality (Small Pharma)
Reliability (Overall, Small Pharma)
Service (Small Pharma)

John McQuaid, President and Managing Director, Almac Pharma Services, commented: “Our mission is to advance human health by providing high quality, end-to-end solutions to our clients and ultimately their patients. Receiving recognition, for yet another year, demonstrates our commitment to excellence in pharmaceutical development and commercial supply services and is particularly significant as we have been assessed by our valued clients.”

Stephen Barr, President and Managing Director, Almac Sciences, added: “Once again, I am delighted and proud that Almac has been recognised by our clients via the Life Sciences CDMO awards. To win in all six categories further endorses our excellence in research, development and manufacturing of high-quality chemical products used in high-profile consumer industries across the globe. We will continue to drive innovation to deliver exceptional science, sophisticated technology and unparalleled expertise.”

Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma said: “Drug and therapy sponsors had much to be concerned with the last 12 months or so. There was still supply-chain uncertainty, ever-growing novelty in platforms and processes requiring new skillsets and technologies, and the speed of everything seemed to accelerate. Through it all, CDMOs stayed focused, and also adapted to customer and market needs. Those best at serving their customers (and thus patients) are recognized as the 2024 CDMO Leadership Award winners. CDMOs may not have had all the answers in an uncertain year, but these are the external partners who provided the biopharma industry with the best solutions.”

The company has just announced the completion of two new purpose-built facilities to expand its commercial manufacturing and packaging as well as peptide production as part of its ongoing global expansion investment programme.

The post Almac Group Awarded six 2024 CDMO Leadership Awards appeared first on Almac.

Almac Group Expands Commercial Manufacturing and Packaging as well as Peptide Production Capacity

brendanhagan — Wed, 06 Mar 2024 08:45:59 +0000

Ongoing Global expansion investment now totals over £400m / $500m

The Almac Group has today announced the completion of two new purpose-built facilities at its headquarters in Craigavon, Northern Ireland meeting client demand in commercial manufacturing and packaging as well as peptide production.

The multi-million-pound large-scale expansion substantially grows operations for two of the Group’s business units, Almac Pharma Services and Almac Sciences.

The first of these two major projects is a 32,000 square feet custom-built high-volume facility for Almac Pharma Services that significantly increases commercial manufacturing and packaging of sachet drug product presentations. The investment includes additional large-scale manufacturing suites, automated primary and secondary sachet packaging technologies and also expands the company’s QC Laboratory Testing capacity.

The second project is a 28,000 square feet GMP facility that more than doubles peptide API manufacturing capacity for Almac Sciences. It will enhance synthesis, purification and isolation capabilities and meet anticipated demand for clinical development and commercial products.

These new developments are part of Almac’s global investment programme announced in June 2022. Since the start of the programme Almac has also announced a Centre of Excellence for Commercial Drug Product Partnership; a CDx Development, Manufacturing and Commercial centre; a drug substance GMP facility for clinical and commercial manufacturing; further expansion to clinical production and distribution capabilities in Souderton, Pennsylvania and the launch of cryogenic and ultra-low service capabilities for clinical supply in Durham, North Carolina.

Graeme McBurney, Chief Operating Officer, Almac Group said: “Today’s announcement of continued expansion ensures that we remain the global leaders in our industry, giving our clients and ultimately patients across the world who benefit from these therapeutics, the best possible offering from Almac.

“Our new peptide API manufacturing facility will significantly grow our portfolio of client APIs and is the latest stage of a wider development and manufacturing expansion initiative for Almac Sciences. The business has also recently opened a new technology development centre, installed additional small molecule API GMP reactors, and opened a dedicated chemical warehouse.

“In the drug product service arm of our business, Almac Pharma Services is adding to its large-scale commercial manufacturing and packaging capabilities in response to growing demand for tailored solutions to meet clients’ market growth needs. This allows us to support our clients throughout a drug’s lifespan, from early development through to commercialisation.

“Almac Group believes it is vital to keep growing our capacity and our range of service offerings to meet the growing needs of all our clients now and into the future. I am extremely proud of the strong, global reputation that Almac has built over the last 55 years as a trusted and stable CDMO partner for the world’s leading biopharma companies.

“We are a privately-owned and independent company, committed to re-investing all our profit back into the business so that we can continuously innovate and expand, enabling us to support our clients and together advance human health.”

The post Almac Group Expands Commercial Manufacturing and Packaging as well as Peptide Production Capacity appeared first on Almac.

Almac Sciences extends selectAZyme™ offering to include therapeutic oligonucleotide synthesis

brendanhagan — Thu, 25 Jan 2024 12:00:00 +0000

Synthesis leverages new RNAL Ligase (RNAL) enzyme kit, a focussed library of 10 double stranded RNA Ligase enzymes selected from Almac Sciences’ extended RNAL enzyme panel

Almac Sciences, a member of the Almac Group, announces new capability to synthesize therapeutic oligonucleotides, made possible by the introduction of a new an easy-to-use RNA Ligase (RNAL) enzyme kit that extends the company’s selectAZyme^TM enzyme screening collection.

The kit contains a focussed library of 10 double stranded RNA Ligase enzymes, selected from an extended RNAL enzyme panel, and can be used to make single and double stranded RNA— as described in technical paper by Caswell et al. ACS Chem. Biol. 2023, 18(10), 2183-2187.

This marks the first time that Almac’s award-winning enzyme technology has been applied to therapeutic oligonucleotide synthesis, a class of drug that has rapidly grown in interest due to their synthesis and manufacture. Building upon the strong biocatalytic technology base already available at Almac, this newly available synthesis leverages the company’s selectAZyme™ ligase enzymes to produce both single stranded and double stranded oligo products.

The Ligase panel has the following attributes:

Manufacture of high-quality RNA oligo product using the Almac ligase 3:2:3:2 approach via RNA blockmer assembly,
Activity against both natural and unnatural nucleosides with modifications including 2’F, 2’MOE & 2’OMe modifications and many more,
Enzymes can be immobilised and/or provided with low-endotoxin levels on request,
The enzymes can be used to complement existing oligonucleotide synthesis by combining a biocatalytic approach with existing classical chemical synthesis,

Choosing a complementary biocatalysis route for oligonucleotide synthesis offers many benefits including higher isolated purity of the RNA product, purity enrichment via ligation of the blockmers due to complementarity of base pairing. This technology also allows for convergent synthesis opening up new supply chain opportunities.

Dr Jill Caswell, Biology Senior Team Leader commented “Almac has developed a range of biocatalytic products and services to facilitate the challenges posed in biocatalytic oligonucleotide synthesis and this new RNAL kit has the ability to diversify and strengthen supply chain blockmer manufacture which can often shorten timelines, benefitting our customers greatly. The expansion of our portfolio of product offerings further showcases our commitment to providing our customers with the most innovative and efficient processes.”

The selectAZyme^TM RNA Ligase kit is readily available now and extended panels of double stranded RNA Ligase enzymes are available on request as well as single stranded RNA Ligases.

The post Almac Sciences extends selectAZyme™ offering to include therapeutic oligonucleotide synthesis appeared first on Almac.

Almac Sciences and HydRegen successfully complete first scale up of their joint development project

brendanhagan — Wed, 11 Oct 2023 08:00:00 +0000

Joint project to develop sustainable chemical processes funded by UK Innovation & Science Seed Fund (UKI2S) and Innovate UK (IUK)

Almac Sciences, a member of the Almac Group, in partnership with HydRegen, has completed the first scale up demonstration of the joint Almac Sciences – HydRegen bio-manufacturing route to a critical commodity chemical, achieving >99.9% conversion in industrially relevant timeframes in a kilo-lab hydrogenation facility.

The demonstration combines Almac Sciences’ Carbonyl Reductase (CRED) enzyme with HydRegen’s proprietary enzyme platform with a ‘lead’ for clean and efficient carbonyl-to-alcohol conversion. This demonstration takes the HydRegen platform for enabling biocatalytic hydrogenation closer to large-scale manufacturing and showcases its capabilities for supporting a more energy, cost and resource efficient chemicals sector.

The project, funded by UK Innovation & Science Seed Fund (UKI2S) and Innovate UK (IUK) alongside private investors, was launched 18 months ago to develop and scale up the HydRegen technology for more sustainable commodity chemical manufacturing and subsequent implementation into new chemical processes.

Prof. Tom Moody, VP Technology Development and Commercialisation at Almac Sciences said: “I am very pleased to see the high conversion achieved by the team using the HydRegen technology coupled with the Almac CRED enzyme. I look forward to running this process under flow conditions and showcasing the benefits of running this bioreduction.”

Click here for more detailed information on the joint project.

The post Almac Sciences and HydRegen successfully complete first scale up of their joint development project appeared first on Almac.

Almac selected as finalist for KTP “Best of the Best” awards

amoreland — Fri, 01 Sep 2023 13:08:41 +0000

The only Northern Irish company to reach the finalist category of awards to celebrate the most positive impacts of Knowledge Transfer Partnerships

Almac Sciences, a member of the Almac Group, has been shortlisted as a finalist in the Technical Excellence category at this year’s national Knowledge Transfer Partnership (KTP) Awards by Innovate UK.

The award nomination was based on the successful completion of a three-year research project in collaboration with Queen’s University Belfast (QUB) and is the only Northern Irish submission to be shortlisted.

The project involved the development of highly innovative continuous flow processes with a key focus on high pressure hydrogenations to access critical raw materials for the chemical industry. This project was recently awarded the highest grade of “outstanding” by the grading panel after successfully meeting all the KTP’s objectives and is only one of three finalists in this prestigious category.

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for critical raw materials through development of a continuous flow technology. Continuous flow chemical manufacture is impacting the drive to strengthen supply chain resilience, contribute to Net Zero Impact and support continued growth of the chemical manufacturing sector here in the UK.

Gary Morrison, former KTP associate is now a Chemist in the Custom and Flow team at Almac commented: “It is an honour to be shortlisted as a finalist in the Technical Excellence category at this year’s national KTP awards by Innovate UK. Contributing to the evolution of flow chemistry expertise at Almac throughout the 3-year project has been hugely beneficial and I am delighted that we have been recognised. I would also like to thank my academic and industrial mentors Dr. Haresh Manyar and Dr Megan Smyth for their expertise and advice.”

Dr. Scott Wharry, Custom and Flow Chemistry Manager, Almac Sciences added: “We once again offer our congratulations to the whole team on this recognition. The KTP project has been a huge success which has embedded new technology, capacity and knowledge into Almac. As an organisation we understand the criticality of creating academic partnerships via programs such as KTP to help drive innovation whilst developing the necessary skills to secure a pipeline of talent within the pharmaceutical industry.”

The KTP awards ceremony will be held on Wednesday 18th October in Cardiff.

The post Almac selected as finalist for KTP “Best of the Best” awards appeared first on Almac.

Almac Group opens a new custom-built GMP warehouse at its Global Headquarters

amoreland — Wed, 19 Jul 2023 13:00:00 +0000

The new custom-built facility will consolidate the existing warehouses to support all manufacturing and laboratory activities.

Almac Sciences, a member of the Almac Group, has officially opened a new custom-built GMP warehouse and dispatch hub at its Global Headquarters in Craigavon, UK.

The new 19,500 square foot facility consolidates the existing warehouses and supply chain offices and will provide support to all Active Pharmaceutical Ingredient (API) manufacturing and laboratory activities, from development to commercialisation.

The warehouse has capacity to store 500 pallets of solvent, 800 pallets of 15-25^oC materials as well as walk-in fridge and freezer- all of which are connected to an Environmental Monitoring System (EMS). The facility also houses downflow booths for sampling incoming materials and is the centralised location for all staff in the Supply Chain department. An extensive expansion area also remains for additional office space on the first floor.

This new building forms part of the multi-million-pound manufacturing investment programme to support client requirements. The first stage of Almac’s GMP facility expansion was announced in December 2022 with an extension to its current GMP manufacturing facility. The next stage will create manufacturing centres of excellence to support small molecule API production at up to 200 – 300kg scale, as well as increased capacity for peptide API production.

Michael Rainey, Head of Supply Chain, Almac Sciences said: “The new warehouse has been designed to ensure there is sufficient capacity to support our manufacturing expansions in line with the GMP storage of raw materials and manufactured API. The consolidation of the Warehouse areas and Supply Chain offices provides a new central location for the warehousing, purchasing, imports and dispatch teams to provide support to the business’ ongoing growth plans.”

Dr Dan Bayston, Vice President, Small Molecule API, said: “Almac Sciences is undergoing a period of rapid growth and expansion within its manufacturing areas and our new warehousing and dispatch facility is critical to support the increased demand from our clients. This new facility at our global headquarters expands storage capacity by ~300% which aligns with our future growth plans within manufacturing, allowing us to better serve our clients, and ultimately patients, worldwide, thus enabling us to enhance human health.”

The next phase of development is currently underway with further manufacturing expansions which will be announced in due course.

The post Almac Group opens a new custom-built GMP warehouse at its Global Headquarters appeared first on Almac.

Almac Group Wins Life Sciences Team of the Year

amoreland — Fri, 07 Jul 2023 08:00:00 +0000

Almac Sciences, a member of the Almac Group, is delighted to announce a win in the Life Sciences Team of the Year category during this year’s Irish Life Sciences Awards ceremony, held on 6 July 2023 at Crowne Plaza Hotel, Dublin.

Almac Sciences’ Technology Group was selected as the winner of the “Life Sciences Team of the Year” category. The Technology Group is a multi-disciplinary team, offering a toolbox of innovative technology solutions for synthetic chemistry including biocatalysis, biology services, custom and flow chemistry, radiochemistry and physical sciences right through to manufacture on tonne scale.

Key to the success of the team is the integration of multi-disciplinary scientific expertise with the aim of developing new greener and sustainable chemical processes that go beyond the traditional realms of chemical synthesis. The team has delivered multiple innovative manufacturing processes for their clients and has enhanced Ireland’s position as a global chemical manufacture for the pharmaceutical and fine chemical sectors.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, commented: “Receiving this award demonstrates our excellence in the research, development and manufacturing of high-quality chemicals which will ultimately be used in high-profile consumer and healthcare products across the globe.

“We are delighted that the Pharma Industry Awards have recognised our team for offering innovative technology and our contribution to chemical manufacture in a more sustainable way. We look forward to further contributing to the Island of Ireland’s growing role as a global hub of exceptional science, sophisticated technology and unparalleled expertise in chemical manufacture.”

The post Almac Group Wins Life Sciences Team of the Year appeared first on Almac.

Almac Sciences and University College Dublin BROADEN Continuous Flow Chemistry Collaboration

amoreland — Thu, 04 May 2023 13:10:01 +0000

Almac Sciences, a member of the Almac Group, announces a strengthened collaboration with University College Dublin (UCD) that will focus on the development of novel continuous flow protocols for accessing new industrially relevant drug targets.

The new project, entitled “BROADEN”, involves continuous flow in-situ Bromination for Application in the synthesis of Drugs and thEir buildiNg blocks. These are among the most fundamental transformations in organic chemistry, allowing the functionalisation of simple substrate molecules to become advanced building blocks for today’s drugs.

Successful completion of BROADEN will result in a competitive edge for chemical manufacturing in Ireland including societal impacts through improved access to cheaper chemicals and medicines, economic impacts (lowering cost of goods, shorter processes, less waste) and improved sustainability metrics.

This is a four-year project, co-funded by Almac Sciences and the Irish Research Council, through their enterprise partnership scheme. It will develop methods that generate bromine from benign precursors and through continuous flow approaches, immediately consume the reactive intermediate in a variety of industrially relevant chemical transformations. The project expands the existing collaboration with Dr Marcus Baumann at UCD where a range of projects utilising continuous flow for both oxidations and enzyme mediated transformations are ongoing.

Davin Cronly, PhD student at UCD, said: “This research is exciting as there is the potential to develop innovative solutions to complex scientific challenges. I want to use my knowledge as a chemist to make a real impact on the lives of those around me and I am looking forward to spending time at Almac Sciences to learn from industrial experts.”

Dr Megan Smyth, Team Leader and UKRI Future Leaders Fellow, Almac Sciences commented: “We are delighted to welcome Davin to the collaborative team we have established between Almac Sciences and UCD. I look forward to mentoring and working closely with Davin in the development of novel continuous flow protocols, applying/disseminating these outputs into industrial best-practice and wish him every success in his studies.”

The post Almac Sciences and University College Dublin BROADEN Continuous Flow Chemistry Collaboration appeared first on Almac.

Almac Sciences successfully completes an outstanding Knowledge Transfer Partnership with QUB

amoreland — Wed, 15 Mar 2023 16:00:00 +0000

Almac Sciences has been awarded the highest grade of “outstanding” by the KTP Grading Panel.

Almac Sciences, a member of the Almac Group, has been awarded the highest grade of “outstanding” by the Knowledge Transfer Partnership (KTP) grading panel following the successful completion of a three year project in collaboration with Queen’s University Belfast (QUB).

The project which looked at the development of highly innovative continuous flow processes with a key focus on high pressure hydrogenations received the highest accolade after successfully meeting all of the KTP’s objectives.

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for key raw materials through development of a continuous flow platform technology. Continuous flow approaches are impacting the drive to ensure novel, improved technologies strengthen supply chain resilience, contribute to Net Zero Impact and support continued growth of the manufacturing sector.

Dr. Megan Smyth, Team Leader and UKRI Future Leaders Fellow, Almac Sciences commented: “The KTP project has been a huge success which has embedded new technology capacity and knowledge into Almac. As a CDMO, having a wide range of synthetic capabilities is essential to deliver on the complex target chemical structures that our customers contract us to manufacture.”

The main achievements from this KTP partnership include the build and installation of flow rigs within Almac Sciences and the successful delivery of multiple projects at 100’s of kgs scale. Project success has been disseminated through peer reviewed publications, multiple conference presentations, poster prizes and retention of the KTP associate in a full-time employment within the company.

Dr. Scott Wharry, Custom and Flow Chemistry Manager, Almac Sciences, commented: “Congratulations to the whole team on the successful completion of the KTP. Receiving the highest accolade is testament to the hard work throughout the project. The flexibility and resilience demonstrated by both the KTP associate, Academic supervisor and Company supervisors during the pandemic was admirable as they worked tirelessly to ensure project delivery and managed change to deliver with a business-centric focus.”

The post Almac Sciences successfully completes an outstanding Knowledge Transfer Partnership with QUB appeared first on Almac.

Almac Group Awarded with Six CDMO Leadership Awards Across all Core Categories

amoreland — Tue, 21 Feb 2023 12:00:00 +0000

Overall recognition received for compatibility, expertise, quality and reliability.

Craigavon, N.I. – Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won six CDMO Leadership Awards for 2023.

The CDMO Leadership Awards recognise top performing CDMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. The winners will be presented with an award at a ceremony on 22nd March in New York.

Primary market research by Industry Standard Research (ISR) is the basis of the awards. 72 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. This experiential feedback was analysed by sponsor company size to reveal leading CDMOs in different performance categories. CDMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Almac was successful in achieving awards in all core categories including:

Excellence in Capabilities (Small Pharma)
Compatibility (Overall and Small Pharma)
Expertise (Overall and Small Pharma)
Quality (Overall and Small Pharma)
Reliability (Overall and Small Pharma)
Service (Small Pharma)

Winners in each of these categories were judged by their customers as either exceeding expectations or as top performers in outsourced projects conducted within the past 18 months.

Outside of the core metrics, Almac also received individual attribute awards for five additional categories – accessible senior management, innovation, on-time delivery, reputation and right first time.

John McQuaid, President and Managing Director, Almac Pharma Services, commented: “I am both delighted and proud that Almac has been recognised again by Life Science Leader at the annual CDMO awards. To have won in all six categories, and four overall reflects the commitment of the Almac team who work hard to provide best-in-class, tailored solutions to our global client base and their patients. The accreditations are particularly meaningful as we have been evaluated by customers we have partnered with.”

Stephen Barr, President and Managing Director, Almac Sciences, added: “To receive this recognition, influenced directly from our clients, is a fantastic endorsement and testament to our excellence in research, development and manufacturing of high-quality chemical products used in high-profile consumer industries across the globe. We are delighted that Life Science Leader has recognised our team for delivering innovative, original, and high-quality service and solutions in these categories which has contributed significantly to the betterment of human health.”

Kate Hammeke, Vice President, Industry Standard Research said “Industry Standard Research is proud to be a part of the CDMO Leadership Awards. ISR’s research methodology ensures that the people who participate in the contract manufacturing benchmarking market research are highly qualified decision-makers with first-hand experience working with the suppliers they evaluate. These awards are based on experiential feedback and enable users of ISR’s market research to make data-driven decisions with respect to choosing an outsourcing partner. It also means the winners of these awards have been delivering the highest quality of service according to their current and recent customers and are deserving of these accolades for their distinction.”

To learn more about Almac’s exceptional culture and commitment to quality, please visit our website: https://www.almacgroup.com

The post Almac Group Awarded with Six CDMO Leadership Awards Across all Core Categories appeared first on Almac.

Almac Group Opens Registration for Internationally Recognised Process Chemistry Forum in Belfast

amoreland — Thu, 26 Jan 2023 12:00:00 +0000

Registration is now open for the Nordic-Irish Process Chemistry Conference, June 2023

Almac Sciences, a member of the Almac Group, is delighted to announce that registration is now open for the Nordic-Irish Process Chemistry Forum, taking place from 6 – 8 June 2023. This internationally recognised forum for leaders in process chemistry, will be held in Belfast, Northern Ireland for the very first time in the event’s history.

As a leader in process chemistry and R&D, Almac Sciences will host the forum, which has a long history of attracting some of the most respected and innovative speakers in the world of chemistry. The Belfast event will be the 9th forum since it was founded in 2004.

The main driver of the forum has always been to bring together scientists who are involved in the design and scale up of chemical processes. This upcoming event in Belfast is no exception — an impressive line-up of industrial and academic speakers has been secured for the forum including Professor Oliver Kappe, Professor Anthony Burke and Professor Andreas Liese, covering a range of subjects within the process chemistry field.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company commented: “We are excited to share our agenda and formally open this event for registration. Participants will truly benefit from learning about the rich chemistry expertise and innovative research taking place among industry and academia across the EU and within the island of Ireland. For the first time we are also giving PhD students the opportunity to showcase their research studies in front of industry peers. There will be no better audience to engage with and I strongly urge early registration.”

The Nordic Irish Process Chemistry Forum will be held from 6 – 8 June 2023 at W5, Belfast, Northern Ireland. Visit the dedicated webpage at https://npcf2023.com to register and find out more about the agenda and participation opportunities.

The post Almac Group Opens Registration for Internationally Recognised Process Chemistry Forum in Belfast appeared first on Almac.

Almac Group secures HPRA certification for biologics testing

davidkane — Wed, 14 Dec 2022 15:00:00 +0000

Health Products Regulatory Authority (HPRA) has certified Almac Sciences Ireland (ASI) facility for testing of biologics after a successful audit

Almac Sciences Ireland, a member of the Almac Group, has secured certification from the Health Products Regulatory Authority (HPRA) for biologics testing after a successful audit.

The certification adds to Almac’s existing GMP certificate, renewed in 2022, which covers testing raw materials, small molecules and microbiology. This additional certification enables Almac to perform biologics testing for the determination of product quality attributes throughout the drug development cycle, from development to commercialisation.

The analytical testing lab, based in Athlone, Ireland, provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programmes adhering to industry regulations including FDA, EMA and HPRA under GMP standards.

Almac’s biologic testing services include GMP lot release and stability testing to support clients’ drug substance and drug product programmes for both novel biologics and biosimilars. It also includes fit-for-purpose analytical method development / phase-appropriate method validation; raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.

The addition of this biologics certification complements the well-established range of analytical services already offered from Athlone as well as its global headquarters in Craigavon, UK and Almac’s facility in Pennsylvania, North America.

Dr Pavan Kumar Kunala, Biopharma Lab Manager for Almac Sciences said: “I am delighted that our lab has received this HPRA certification which will enable us to offer enhanced analytical testing services to our clients. With the current landscape of increased growth in biologics post-pandemic, Almac’s service offering for biologics testing reiterates the commitment to provide superior solutions in the advancement of human health.”

Dr Simon Cocks, Site Manager of the Athlone laboratory, added: “Achieving this certification is testament to the commitment of the biologics testing team. Biologics have gained huge traction in the last decade and are poised for stronger growth in the coming years, with potential to significantly impact patient lives. We are confident that the addition of this biologics testing certification will continue to strengthen our competitive position in the marketplace.”

ENDS

About Almac Group

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the USA and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group secures HPRA certification for biologics testing appeared first on Almac.

Almac Group Completes First Stage of GMP API Facility Expansion

davidkane — Tue, 06 Dec 2022 12:00:00 +0000

Expanded GMP manufacturing facility now operational for use in clinical and / or commercial manufacturing

Almac Sciences, a member of the Almac Group, has completed the first stage of its GMP API facility expansion in a multi-million-pound investment programme.

An extension to the current API facility situated at Almac Group’s global headquarters in Craigavon, the completed installation hosts an additional 2 x 1000 L Glass Lined Steel Reactors with associated filtration and drying equipment allowing the manufacture of 50 – 100 kg batch API output.

Almac Sciences has grown rapidly over the last five years and this expansion is the latest stage of a multi-million-pound investment programme to support increased client manufacturing demands. The ongoing investment programme will create manufacturing centres of excellence to support small molecule API production at up to 200 – 300kg scale, as well as increased capacity for peptide API production.

The fully operational facility complements the R&D technology centre opened in 2021 for Almac’s established biocatalysis, flow chemistry and peptides businesses.

Dr Dan Bayston, Vice President, Small Molecule API, said: “The investment in this new manufacturing facility has been critical to support the increased demand from our clients. As our business grows, we are experiencing an ever-increasing pipeline of projects taking advantage of our integrated offering from development through to manufacture and are delighted that this expansion provides us with a stronger ability to serve our global customer base.”

Active recruitment to fill production technician, engineering and Quality Assurance positions is well underway to support current and future manufacturing demands. These roles are critical for Almac’s continued success with further opportunities for career progression and growth.

The next phase of development is currently underway with further manufacturing and warehousing expansions which will be announced in due course.

#ENDS#

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Completes First Stage of GMP API Facility Expansion appeared first on Almac.

Almac’s Higher Level Apprentice success in WorldSkills UK National Competition

davidkane — Thu, 01 Dec 2022 09:00:00 +0000

Three Almac Group Chemical Sciences Higher Level Apprentices (HLAs) have been successful at this year’s World Skills UK National Competition. Anastasiya Kovtun won bronze and Wiktoria Kurkowska and Abigail Magill both received Highly Commended.

Almac’s Higher Level Apprentice success in WorldSkills UK National Competition

Anastasiya and Abbi from Almac Sciences and Wiktoria from Almac Pharma Services are currently completing their HLA programme through the organisation’s partnership with Southern Regional College. This partnership provides a range of apprenticeship opportunities for students interested in a career at Almac.

Almac’s HLAs competed among 500 finalists at the competition which took place across the UK this week. As a bronze medal winner, Anastasiya may have the opportunity to represent the UK at the “Skills Olympics” in France in 2024.

World Skills UK is an independent charity which partners with employers, education and government and is a member of the global body, WorldSkills, created to support young people via competitions-based training, assessment and benchmarking.

Tanya Graham, Sciences’ Head of Analytical Services, said: “We offer huge congratulations to Anastasiya, Abbi and Wiktoria on their success in the WorldSkills UK development programme. We are delighted for you and extremely proud of the achievement of all our HLAs who competed.

“Almac’s apprenticeship programmes enable students to develop the technical knowledge and skills they need to support projects at different stages in drug development. The support and mentorship we offer our apprentices, as well as the opportunity to take part in competitions like WorldSkills, really helps our apprentices develop valuable interpersonal skills and grow in confidence in their respective roles.”

Almac’s partnership with Southern Regional College has created 66 apprenticeship jobs, over two thirds of whom are still working within the group and we are aiming to train over 100 apprentices by 2025.

ENDS

The post Almac’s Higher Level Apprentice success in WorldSkills UK National Competition appeared first on Almac.

Odyssey Trust invests £3 million in state-of-the-art new centre to offer Learning Innovation for Everyone

davidkane — Thu, 01 Dec 2022 08:00:00 +0000

The Odyssey Trust has opened a state-of-the-art learning centre, LIFE at W5, as part of a major extension to its mission to offer Learning Innovation For Everyone.

Representing a capital investment of circa £3million, the facility will support the learning and skills pipeline in Northern Ireland, creating and nurturing future talent for STEM and technology sectors. Working in partnership with industry partners including Microsoft, Almac and Belfast Harbour, the Odyssey Trust anticipates the centre will offer skills-based learning and training programmes and outreach to over 160,000 people over the next five years.

The impressive 20,000sq. foot space occupies the former Bambu Beach Club and is part of the overall reimagining of the Odyssey complex. LIFE at W5 will offer on-site and digital outreach programmes to foster and facilitate opportunities for young people in industries with real and tangible career opportunities.

Particular effort will be made to identify and engage with hard-to-reach schools, young people and adult learners in underrepresented communities, through strategic linkages and direct community engagement work.

Commenting at the opening, Robert Fitzpatrick, CEO, The Odyssey Trust said: “Building on over 20 years of STEM based learning in W5, this dedicated hub will provide a new home for learning, that is welcoming and accessible to all. We wanted to create a space, outside of the realms of formal education, where people from across Northern Ireland could come to learn more about themselves, and perhaps the opportunities they have missed, or may not have considered previously.

“We believe this space has the potential to be a catalyst to properly engage and deliver the new 10x Skills Agenda, that will increase understanding and awareness of technologies and associated careers pathways. Ultimately, we hope to help nurture, develop, and retain talent that will be crucial to our future economic and societal wellbeing. This vision aligns with the charitable objectives of The Odyssey Trust to improve the life chances for people in Northern Ireland.”

Collaborative partnerships with industry will be core to the success of the programmes offered by the new centre, which it is hoped will reach in excess of 40,000 participants each year.

Judith Harvey, Group Head of Education and Public Engagement, Odyssey Trust said: “As a charitable Trust, we want to make a difference. Our programming will focus on accessible and inclusive approaches to gaining employability and life skills, not just for young people, but across all life stages, promoting true lifelong learning.

“Working collaboratively with our founding partners Microsoft, Almac and Belfast Harbour, we are developing programmes that will have a positive impact on people’s lives, whilst addressing the skills gaps needed to grow the NI economy and create jobs. Programmes will have inbuilt progression and industry accreditation opportunities, linked to employability pathways.”

Within LIFE at W5, Microsoft has invested in the creation of a dedicated Microsoft Dream Space experience for the students and teachers of Northern Ireland to access. The fully immersive STEM experience has been developed by Microsoft in partnership with educators to inspire, encourage and challenge students to think creatively in areas such as computer science, AI, Mixed Reality, and robotics.

Speaking about the investment Anne Sheehan, General Manager, Microsoft Ireland said: “At Microsoft, we’re passionate about helping young people to engage in STEM learning and shift their perceptions about the role technology can play in their future career choices. With digital technology reshaping how we live, work, and learn, it is important that young people develop digital skills at the earliest opportunity. That’s why, four years ago we invested in the Microsoft Dream Space experience and just recently announced our commitment to its continued growth and expansion over the next four years.

“We’ve had many students from Northern Ireland based schools both participate in our virtual Dream Space offering and attend our hub at our campus in Dublin, however, it was always an ambition of ours to have a physical Dream Space experience here in Northern Ireland. It’s great to have reached this milestone and to be here today celebrating the official opening. We look forward to our continued partnership with the team at Odyssey Trust and the impact we can have together.”

Almac will build on its work in MED-Lab, W5’s interactive medical themed exhibition area, to develop STEM programmes and career-based learning, exploring potential opportunities in medical and life sciences.

Dr Stephen Barr, Managing Director and President of Almac Sciences and Almac Discovery said: “We are delighted to be a partner with the Odyssey Trust on LIFE at W5. As a business that employs over 6,500 individuals globally, our success depends on the talent and skills of our most important asset, our people. At Almac we know that career pathway decisions can start as early as 10 years of age and so investing in the potential of Northern Ireland’s young people is crucial to developing the next generation of talent.”

As an extension of its community outreach partnerships with the Belfast Giants and W5, Belfast Harbour will support the development of programmes that will serve underrepresented communities.

Joe O’Neill, Chief Executive of Belfast Harbour, said: “As a socially responsible port that is committed to inclusivity, equality and providing a gateway to opportunity for all, Belfast Harbour is excited to support the opening of the new LIFE at W5 centre. The centre’s core objective to create tangible new career opportunities for young people aligns with Belfast Harbour’s own commitment to encourage and support the development of skills and to improve access to employment in our local communities.”

For further information, visit www.w5life.co.uk

ENDS

Notes to editors:

The Odyssey Trust Company is a registered charity and was established to, ‘hold, manage, safeguard and develop the investment in the Odyssey project for the benefit of all the people of Northern Ireland’.
The Odyssey Trust provides educational advancement and Learning activities at W5, the interactive science and discovery centre, and by offering a wide range of recreation and leisure activities and events in The SSE Arena, Belfast, and the Odyssey complex. The Odyssey is widely recognised as one of the most successful millennium projects funded by the Big Lottery in Northern Ireland.
In 2019, the Odyssey Trust acquired circa 20,000 sq. ft of space within the extended footprint of the former Odyssey Pavilion, which was designated as a potential new Learning Centre.
Significant conversations with industry partners led to the development of a plan to deliver this new space, which includes a sustainable recurrent funding model for 10 years.
To date the Trust has invested circa £3m capital in this innovative project.

The post Odyssey Trust invests £3 million in state-of-the-art new centre to offer Learning Innovation for Everyone appeared first on Almac.

Almac Group Hosts Internationally Recognised Chemistry R&D Forum in Belfast

amoreland — Tue, 15 Nov 2022 11:46:33 +0000

Nordic-Irish Process Chemistry Conference re-scheduled to June 2023

Almac Sciences, a member of the Almac Group, has announced that the Nordic Process Chemistry Forum, an internationally recognised forum for leaders in chemistry, will be held in Belfast, Northern Ireland for the very first time in the forum’s history. Traditionally hosted by Nordic-based companies, this move has resulted in the forum being renamed to the Nordic-Irish Process Chemistry Forum in advance of the event, which was originally scheduled to run in May 2020 but rescheduled due to the global COVID-19 pandemic.

As a leader in process chemistry and R&D, Almac Sciences will serve as the host during the forum from 6^th to 8^th June 2023. The Nordic Process Chemistry Forum has a long history of attracting some of the most respected and innovative speakers in the world of chemistry, and the Belfast event will be the 9th event forum.

Since the event was founded in 2004, by a group representing pharma company AstraZeneca and CRO/CMO Syntagon, all based in Sweden, the main driver of the forum has been to bring scientists together who are involved in the design and scale up of chemical processes. The event facilitates networking, addresses pertinent chemical challenges, and fosters idea sharing and hosts new chemical trends. The upcoming event in Belfast is no exception— a fantastic line-up of industrial and academic speakers has been secured for this event, covering a range of subjects within the process chemistry field. A dedicated website has been created for this event (see below) and expression of interest is now open with opportunities for participation.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac and Arran Chemical Company commented: “We have established excellent relationships with the Nordic Process Chemistry industry and are delighted to be entrusted to host this event in Northern Ireland. The rich chemistry expertise and innovative research taking place among industry and academia across the EU and within the island of Ireland will be showcased this at the event. We are delighted to re-schedule this prestigious event and look forward to hosting our guests in Belfast where chemistry will be brought to life.”

Professor Hans-Jurgen Federsel, co-Founder of the Nordics forum, said: “The basic idea behind starting the Nordic Process Chemistry Forum was the feeling that this part of the world was in dire need of a meeting where chemists, notably active in an industrial setting, could meet biannually and share top scientific and technical achievements. Unfortunately, the global pandemic prevented the 2020 event going ahead but I’m personally very happy that my friends at Almac have remained committed to re-organizing the event which will be hosted for the first time outside the realm of the original Nordic countries.”

The Nordic Irish Process Chemistry Forum will be held from 6 – 8 June 2023 at W5, Belfast, Northern Ireland. Visit the dedicated webpage at https://npcf2023.com to register interest and find out more participation opportunities.

#END#

About Almac Group

A unique culture delivering exceptional solutions

Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia.

We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Hosts Internationally Recognised Chemistry R&D Forum in Belfast appeared first on Almac.

Almac Sciences and UCD strengthen collaboration with prestigious SFI grant

evewallace — Tue, 06 Sep 2022 08:00:00 +0000

Development of continuous flow enzyme cascade processes

Almac Sciences, a member of the Almac Group, and University College Dublin (UCD), have been awarded a Science Foundation Ireland (SFI) ‘Frontiers for the Future’ grant.

The €420,000 grant will enable the exploitation, for the first-time, of emerging enzymes such as ene-reductase (ERED) and carboxylic acid reductase (CAR) enzymes in continuous flow reactors to develop new routes to chemical products. Almac Sciences and UCD will work together to establish the use of enzymatic multi-step reactions in continuous flow reactors as readily and widely applicable tools for the sustainable synthesis of fine chemicals.

The project team, co-funded by Almac Sciences, will include one postdoctoral researcher and two PhD studentships over the next 4 years based primarily in UCD. Both PhD students, Ruairi Bannon and Philip Jamieson, have undertaken industry placements within Almac as part of their undergraduate studies. The placement has equipped them with key transferable skills and valuable insights into critical decision-making for flow processes with industrial relevance.

Lead academic at UCD, Dr Marcus Baumann said “This project will further build on our existing collaboration with Almac Sciences, strengthening expertise for continuous flow within Ireland with a focus on enhancing the application of continuous flow within the biocatalysis sphere.”

Almac and UCD have collaborated on various projects over the last few years and have recently been awarded SSPC’s Industry Impact of the Year, recognising their joint development of continuous flow processes using enzymes.

Almac continues to enhance its flow service offering with a completed £500,000 investment to date already in place. This project further establishes Almac Sciences in the field of flow chemistry and builds on novel methodologies applicable for industrial scale transformations.

Dr Megan Smyth, Team Leader Custom and Flow Chemistry, Almac Sciences commented: “Collaborations such as these established with Marcus and UCD are of the utmost importance to us in Almac Sciences. By supporting development of students, we can ensure a pipeline of expertly trained flow chemists in line with our growing capabilities. For Ruairi and Philip, the opportunity to avail of expertise at Almac Sciences and UCD fosters key interdisciplinary skills and research excellence in the area of flow. I am excited to work closely with them both throughout their studies and wish them every success.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Sciences and UCD strengthen collaboration with prestigious SFI grant appeared first on Almac.

Almac Group Expands Laboratory Scale Jet Milling Capabilities for Formulation and Toxicology Studies

davidkane — Tue, 02 Aug 2022 07:00:00 +0000

Craigavon, Northern Ireland – August 2022 – Almac Sciences, a member of the Almac Group, has invested in additional milling capabilities to now provide small scale, non-GMP prototype batches of jet milled material for formulation trials and toxicology studies, including a new Hosokawa Alpine 50AS spiral jet for micronisation of drug substance prepared directly from a tightly controlled crystallisation process.

Jet milling can be an essential process to reduce the particle size of a powder to less than 10 µm. It is also well recognised that by reducing the particle size of a drug substance, the surface area of the powder increases to support faster dissolution or adsorption, subsequently improving its bioavailability. This approach is commonly used for drugs that exhibit poor aqueous solubility or for drugs that are inhaled.

By introducing a Hosokawa Alpine 50AS Spiral Jet mill to Almac Sciences’ toolbox, Almac is now offering small scale non-GMP jet milling on gram to kilogram scale to support the existing GMP jet milling service offering.

Dr Jonathan Loughrey, Physical Sciences Manager, Almac Sciences, commented: “Milling and micronisation are key technologies for pharmaceutical development. Using our experience and knowledge of solid form and formulation development, we are now able to take the next step into providing non-GMP prototype batches of jet milled material for formulation trials and tox studies. By using the existing expertise and available equipment for materials characterization, the Physical Sciences group can now prepare and characterise prototype jet milled batches for direct shipment to our clients or a site specified by them”.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, commented: “Almac Sciences is a science and technology partner, and we are committed to investing in the latest equipment and key technologies to accelerate drug development. We listen to the needs of our clients and are happy to have closed a capability gap in our existing jet milling and micronisation service offering. Being able to offer this key technology from gram to kilogram scale to support non-GMP drug substance development, we can help to accelerate development of drug substances that may exhibit challenging solubility profiles so life changing treatments may be available to patients faster.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Expands Laboratory Scale Jet Milling Capabilities for Formulation and Toxicology Studies appeared first on Almac.

Rising talent receives prestigious £1.5M UKRI Future Leaders Fellowship

evewallace — Wed, 15 Jun 2022 13:00:00 +0000

Further investment set to expand Sciences’ continuous flow platform

Craigavon, Northern Ireland – 15 June 2022 – Almac Sciences, a member of the Almac Group, is delighted to announce Dr Megan Smyth, Team Leader, Custom & Flow Chemistry, has been awarded a highly competitive UK Research and Innovation (UKRI) Future Leaders Fellowship (FLF). The Research and Development grant, worth £1.5 million, funded over a 4-year period, enables further enhancement of innovative continuous manufacturing in tandem with a strong focus on development of strategic leadership thus strengthening the business skills for the Fellow.

The FLF scheme facilitates the development of the next wave of world-class research and innovation leaders for both academia and business. The FLF scheme also supports the Fellows through their ambitious and challenging projects in conjunction with the host organisation.

The project will deliver a platform technology to expand Almac Sciences’ service offering in oxidative chemical continuous processing for the benefit of its global customers. Aerobic oxidations are extremely atom efficient, however fall into a unique category of reactions which are difficult to perform in batch at scale due to safety concerns.

Through horizon scanning it was identified there is a need to the develop an industrially useful oxidative flow platform using air as oxidant. This FLF project will address this need and is necessary for CDMOs like Almac to lead competitively here in the UK.

Dr Megan Smyth commented: “Using flow technology opens up many opportunities to replace traditional stoichiometric oxidants with inexpensive, green and abundant oxygen. Through this grant, my team and I will exploit innovative approaches such as ultrafine bubbles and 3D printing to streamline chemical processing resulting in cost savings for our customers. This oxidative platform will allow us to back integrate raw material synthesis into our manufacturing assets in the UK and Ireland resulting in more secure supply chains.”

Prof Tom Moody VP Technology Development & Commercialisation said: “The overall impact of the project will be diverse and will positively affect the environment, economy and society. It will aid in supporting the competitive edge for the UK chemical manufacturing industry, to securing high skilled jobs for Northern Ireland which will undoubtedly have a multiplier effect. It will also lead to improving sustainability metrics and lowering environmental burden by the essential reshoring of key chemical manufacture to minimise our reliance on Asia.”

Along with exceptional scientific advancements from the innovative research, the Fellowship is a unique programme designed to allow businesses to attract, retain and develop the very best early career innovators delivering new knowledge and understanding and tackling some of the greatest challenges of our time.

Megan added: “I am thrilled to receive this Fellowship which will equip me with a cutting-edge combination of research excellence and transferable management skillsets. The FLF will help to address future economic and societal challenges at Almac Sciences and for the UK. My ambition is to lead a technology platform, driving increased business revenue beyond proof of concept, to manufacture and subsequent supply of chemicals here in the UK. It is an exciting time for me, my team and Almac Sciences.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Rising talent receives prestigious £1.5M UKRI Future Leaders Fellowship appeared first on Almac.

Almac Sciences and Queen’s University Belfast Collaboration Successfully Flows Through Mid-point

allie — Wed, 22 Sep 2021 07:00:00 +0000

Continuing to expand technology capabilities through Innovate UK funded Knowledge Transfer Partnership

Craigavon, Northern Ireland – 22nd September 2021 – Almac Sciences, a member of the Almac Group, has successfully reached the midway point of its continuous flow technology project made possible through an Innovate UK funded Knowledge Transfer Partnership (KTP) in partnership with Queen’s University Belfast.

The aim of the Innovate UK funded KTP is to further enhance established flow technologies platforms at Almac Sciences. The technology will be used for development and manufacture of key raw materials and unlock capacity to perform challenging chemical transformations. The KTP scheme supports business growth through identification of new skills and transfer of the latest academic concepts to deliver a strategic innovation programme.

Modular flow technology for continuous manufacture of chemicals is one of the most exciting technologies in the international pharmaceutical and fine chemical industries. There have been significant efforts in the design of flow equipment and processes globally which includes multi-phase flow reactors, gas/liquid mixers and structured catalysts to offer manufacturing flexibility and robustness in continuous production of chemicals.

The Almac team is now delighted to report its KTP project has passed the mid-point with multiple successful outcomes including dissemination through peer-reviewed publication and several conference presentations detailing the development of a continuous flow packed bed catalytic process for hydrogenation of aromatic nitrobenzoic acids to produce corresponding anilines.

Academic Supervisor, Dr Haresh Manyar, Senior Lecturer in Chemical Engineering at QUB, commented “The hydrogenations under investigation are more efficient, less consumptive and safer than the corresponding batch process. Various industrially important aromatic anilines were produced in excellent yields with high throughputs. A continuous flow approach meant no evidence of genotoxic intermediates and, with the modular reactor design, it can be scaled to produce several kilos without extensive redesign.’ He added ‘This unique collaboration with Almac Sciences is a key milestone for Catalysis research at QUB and we are delighted to work together to advance flow technology within an industrial setting.”

For Almac Sciences, the KTP has a positive reach through increasing competitiveness and productivity with a recent investment of £325,000 in continuous flow, including flow hydrogenation capabilities of up to 100 bar pressure and 300°C. Dr Megan Smyth, Technical Leader, Almac Sciences discussed the positive impact the KTP project has had on the expansion of service offerings within the Technology Group adding, “the ongoing successful knowledge transfer has allowed Almac to deliver kilogram manufacture of product for our customers.”

Dr Scott Wharry, Custom and Flow Chemistry Manager and Company Supervisor, Almac Sciences said “Research and innovation are at the heart of what we do on a daily basis within our Technology group. This KTP project has not only increased capacity but has allowed in-depth understanding on which we can build a platform capability which will underpin future process development and further innovation. I wish the team continued success and look forward to seeing the final outcome of the project.”

#ENDS#

The post Almac Sciences and Queen’s University Belfast Collaboration Successfully Flows Through Mid-point appeared first on Almac.

Almac Group and PILA PHARMA Ink Manufacturing Agreement

allie — Tue, 10 Aug 2021 07:00:00 +0000

Availability of API is a key factor in progressing ongoing type 2 diabetes clinical studies

Craigvon, U.K.- 10 August 2021- – Almac Sciences, global provider of integrated drug development services and member of the Almac Group, is delighted to announce that the company has signed a manufacturing agreement with Swedish biotech company, PILA PHARMA, for the production of XEN-D0501 active pharmaceutical ingredient (API).

From its global headquarter facilities in Northern Ireland, Almac Sciences will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and possibly in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, and subsequently, PILA PHARMA has demonstrated good safety results as well as efficacy, i.e. a statistically improved endogenous insulin response to oral glucose versus placebo in patients with type 2 diabetes, thus demonstrating proof of principle of XEN-D0501.

Commented by Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company, “Almac Sciences is delighted to be working with PILA PHARMA and supporting their API manufacture. The project showcases deployment of our technology platforms including integration of green chemistries and we look forward to further opportunities in this space.”

Dorte X. Gram, CEO, PILA PHARMA states, “The availability of new API is key for us to be able to conduct planned 3-month toxicology studies, that are in turn a prerequisite for initiating our main goal, conducting a clinical phase 2b study with XEN-D0501 in type-2 diabetics. I am, therefore, very pleased to have signed off this agreement and we look forward to the collaboration with Almac on timely delivery of new API.”

The global company has proven expertise in small and large molecule analytics, API supply, stable & 14C radiolabelling, formulation development & solid-state services and earlier this year announced the completion of its £5 million two-storey centre for biocatalysis, flow chemistry technologies and peptide research and development.

The post Almac Group and PILA PHARMA Ink Manufacturing Agreement appeared first on Almac.

Almac Group Announces Four-Year PhD Scholarship at UCL

kelly — Mon, 08 Mar 2021 08:00:00 +0000

Unique academic /industry collaboration supports discovery of novel enzymatic alkylation technology

Craigavon, Northern Ireland – 08 Mar 2021 – Almac Sciences, a member of the Almac Group, has announced its collaboration with University College London (UCL) aimed at investigating the use of enzymes for selective alkylation.

The exclusive programme builds on their strong relationship, first announced in 2013, and will see Almac co-fund a BBSRC London Interdisciplinary Biosciences PhD Consortium (LIDo) iCASE PhD scholarship over the next four years to investigate selective alkylations using enzymes.

Alkyl groups can have a significant beneficial effect on the physicochemical and biological properties of bioactive compounds. However, it is very difficult to achieve selective alkylation reactions using traditional synthetic approaches and toxic reagents are typically used. Enzymatic alkylation provides a highly valuable alternative method using a specific class of transferase enzymes. They are particularly useful enzymes for the regioselective alkylation of compounds as well as the diversification of compound libraries.

Almac is interested in developing the use of these transferase enzymes in selective alkylation reactions with the aim of constructing novel enzyme cascades for the sustainable synthesis of structurally diverse compounds.

Lead academic at UCL, Prof. Helen Hailes says ‘We are very excited to continue to work with Almac Sciences on the discovery and application of transferase enzymes for the selective derivatisation of pharmaceutically relevant compounds and for incorporation into enzyme cascades.”

This latest development demonstrates Almac’s ongoing commitment to innovation as it continues to engineer its technology platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors. This investment comes just weeks after the company announced it had completed a £5 million R&D centre within which its multi-million programme to accelerate enzyme discovery (INSIGHT^TM) is currently underway.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: “We have a strong track record working with UCL that spans more than a decade and look forward to working with Helen, and her new PhD student, Matthew Salinger. I wish Matt every success in his studies and look forward to our first publication together as we welcome him to our new custom-built technology centre at our global headquarters.”

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Announces Four-Year PhD Scholarship at UCL appeared first on Almac.

Almac Group Completes £5million Research & Development Centre

kelly — Tue, 23 Feb 2021 07:00:00 +0000

Significant expansion of biocatalysis, flow chemistry, and peptide capacity

Craigavon, Northern Ireland – 23 February 2021 – Almac Sciences, a member of the Almac Group, has completed a £5 million investment in a new two-storey centre for biocatalysis, flow chemistry technologies and peptide research and development.

Almac Sciences has grown rapidly over the last 5 years with significant investments in its non-GMP and GMP manufacturing plants to support increased client manufacturing demands. Adding to this growth, the first phase of expansion for technology development has been completed with the opening of a new facility housing additional R&D scientists to develop new technology and projects for Almac’s established biocatalysis, flow chemistry and peptides businesses. Additional capacity has also been created to enable further growth of its chemical development offering.

The 2,000m², two-storey dedicated technology centre is located at the Group’s global headquarter campus and consists of 32 fume hoods, an engineering workshop for tooling and has capacity to accommodate up to 100 employees. Active recruitment for 20 additional staff members is underway and with a significant number of projects already commenced.

The completion of this new facility further showcases Almac’s dedication to innovation and investment in technology as it continues to engineer its technology platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors and comes just months after Almac announced its multi-million pound investment to further develop a program to establish IN Silico Informed metaGenomic Harvesting Technology (INSIGHT) continuing its commitment to develop flow processes.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: “The investment in this new, state-of-the-art facility has been critical to support the rapid expansion of our innovative technology offering across different disciplines. As our technology evolves, we are experiencing an ever-increasing pipeline of projects taking advantage of our integrated offering from development through to manufacture. It is an exciting time to be at Almac as our technology success breeds success. We look forward to driving innovation for our clients in this new centre.”

The next phase of development is currently underway with further announcements expected in the coming months.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Completes £5million Research & Development Centre appeared first on Almac.

Almac Group Further Expands Global Biologics Testing Solutions

kelly — Tue, 26 Jan 2021 07:00:00 +0000

£0.5M investment in mass spectrometry support accelerates biologics development and approval

Craigavon, Northern Ireland – 26 January 2021 – Almac Sciences, a member of the Almac Group, has announced additional expansion of its biologics testing laboratory with significant investment in mass spectrometry equipment.

The new high-resolution mass spectrometer has been installed at Almac’s global headquarters, located in Northern Ireland, and will support its biologics offering for the analysis of peptides, proteins, glycoproteins and antibody products. This adds to the existing industry support at its new biologic testing laboratory based in Athlone, Ireland, announced just three months ago, which supports QC release and characterisation of biologics.

The £500,000 investment in a Thermo Orbitrap LC-MS instrument substantially increases the company’s capabilities in solving biologic analytical challenges and underlines Almac’s commitment to providing the latest in cutting-edge analytical solutions, equipment and facilities for its global client base. The instrument is capable of offering a complete analysis package to cGMP including amino acid sequencing, peptide mapping, disulfide bridge analysis using MS and MS/MS, glycosylation analysis, identification of post-translational modifications e.g. acetylation, phosphorylation in addition to biomarker discovery.

With this additional service, clients will benefit from an extended range of mass spectrometry services including the quantitation of genotoxic impurities, structure elucidation, isotopic purity determinations and high-resolution mass spectrometry of both large and small molecules.

John Robson, VP Analytical Services, Almac Sciences commented, “This new mass spectrometer reinforces Almac’s vision of delivering the best for our customers and substantially enhances the level and depth of services we provide.”

John Malone, Analytical Manager added, “We are delighted with this vital investment – whilst customer focus is always our priority, we are confident that the enhanced service offering will benefit our clients further.”

The addition of this equipment further complements the well-established range of analytical services already offered from Almac’s global analytical testing facilities located in the UK, Ireland and North America.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Further Expands Global Biologics Testing Solutions appeared first on Almac.

Almac Group Granted Phase I Award Under the ‘Sustainable Innovation Fund’ to Aid COVID-19 Recovery

kelly — Thu, 10 Dec 2020 09:00:00 +0000

Craigavon, Northern Ireland – 10 December 2020 – Almac Sciences, a member of the Almac Group, has announced it has secured an award under ‘The Sustainable Innovation Fund: Small Business Research Initiative (SBRI) phase 1’ to undertake a project in order to help businesses across the UK recover from the impact of COVID-19 in a sustainable manner.

The initiative is being led by Innovate UK, the UK’s innovation agency, and is a SBRI competition, which will fund organisations to develop and demonstrate new products or services to help businesses and/or the public sector in the UK recover from the coronavirus pandemic in a sustainable manner, demonstrating the impact and potential of a clean growth-led recovery and transition to net zero.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company (Ireland), will lead a team of experts to complete the project entitled ‘Manufacturing Oxidative Products’ over the next 3 months. The funding received from the SBRI will enable the team to demonstrate both innovative flow chemistry and biocatalytic routes to oxidative products as a technology platform for exploitation by UK fine chemical and pharmaceutical industries.

The findings of the project will then be submitted to phase 2 of the Sustainable Innovation Fund and, if successful, could receive additional funding of up to £3 million over a 1-year period to continue the innovative research, development and testing.

Professor Moody commented “The team and I are excited to receive this phase I award from Innovate UK enabling us to conduct vital research into a sustainable method of manufacturing an adequate supply of oxidative products. The coronavirus pandemic has affected many businesses, and indeed individuals, across the world and we are proud to have been selected based on our expertise and capability, to play our part in the sustainable recovery process.”

Innovate UK Executive Chair Dr Ian Campbell said: “In these difficult times we have seen the best of British business innovation. The pandemic is not just a health emergency but one that impacts society and the economy.” He added “Almac’s project, along with every initiative Innovate UK has supported through this fund, is an important step forward in driving sustainable economic development. Each one is also helping to realise the ambitions of hard-working people.”

The COVID-19 pandemic has resulted in an unexpected and unparalleled disruption to UK jobs, businesses, the economy at large and society in general. Recovering will take considerable time and ongoing investment, but the opportunity exists to recover in a sustainable way, resulting in increased prosperity with lower carbon emissions.

This news comes just one month after Almac announced it has been awarded a grant of ~$500,000 by the COVID-19 Therapeutics Accelerator towards developing cost effective, scalable processes for the production of the active pharmaceutical ingredient (API) of the drug remdesivir. Find out more here.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

About Innovate UK

Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas.

We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth.

We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions.

Innovate UK is part of UK Research and Innovation. For more information visit www.innovateuk.ukri.org.

About SBRI

The SBRI programme uses the power of government procurement to drive innovation. It provides opportunities for innovative companies to engage with the public sector and gain contracts to solve specific problems.

Competitions for new technologies and ideas are run on specific topics and aim to engage a broad range of organisations.

SBRI enables the public sector to engage with industry during the early stages of development, supporting projects through the stages of feasibility and prototyping. For more information visit https://www.gov.uk/government/collections/sbri-the-small-business-research-initiative.

The post Almac Group Granted Phase I Award Under the ‘Sustainable Innovation Fund’ to Aid COVID-19 Recovery appeared first on Almac.

Almac Group Works to enable efficient manufacturing of remdesivir in Response to COVID-19

kelly — Tue, 17 Nov 2020 08:00:00 +0000

Grant awarded from the COVID-19 Therapeutics Accelerator

Craigavon, Northern Ireland – 17th November 2020 – Almac Sciences, a member of the Almac Group, has been awarded a grant of ~$500,000 by the COVID-19 Therapeutics Accelerator towards developing cost effective, scalable processes for the production of the active pharmaceutical ingredient (API) of the drug remdesivir.

Remdesivir, an antiviral medication, is the first drug to be approved by the US Food and Drug Administration (FDA) as a treatment for COVID-19 after a trial showed it cut recovery time by five days. In order to ultimately lower raw material usage, increase global yields and lower the overall cost of goods (COG) for the remdesivir development process, Almac Sciences has devised a plan to improve the overall route of synthesis to remdesivir including application of synthetic flow methodology and biocatalysis.

This investment supports efforts to combat the COVID-19 pandemic through the rapid process development and manufacturing of remdesivir.

“We are delighted to receive funding from the Therapeutics Accelerator to apply our skills in the fight against COVID-19,” said Dr Stefan Mix, Head of Biocatalysis, Almac Sciences. “With the skillset of our multidisciplinary teams, we are confident that our developmental approach to the manufacture of remdesivir will positively impact patients’ lives who are in urgent need, regardless of their location.”

“This project highlights Almac’s strength in technology deployment through application of both innovative flow chemistry and biocatalysis technologies to support development of processes which are economical, greener and safer to perform” says Prof. Tom Moody, VP of Technology Development and commercialisation at Almac Sciences and Arran Chemical Company.

The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, with funding from an array of public and philanthropic donors to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale up of treatments.

This news comes just six months after Almac announced it was supporting two COVID-19 clinical studies in Sub-Saharan Africa through a grant also awarded from the COVID-19 Therapeutics Accelerator.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Works to enable efficient manufacturing of remdesivir in Response to COVID-19 appeared first on Almac.

Almac Sciences Achieves Thought Leadership Milestone

kelly — Wed, 14 Oct 2020 07:00:00 +0000

Professor Tom Moody Exceeds 100 Technical Publications Since Tenure at Almac

Craigavon, Northern Ireland – 14 October 2020 – Almac Sciences, a member of the Almac Group, is pleased to congratulate Professor Tom Moody, VP of Technology Development and Commercialisation, for achieving the impressive milestone of over 100 peer reviewed publications since beginning his tenure with the organisation.

Professor Moody is a seasoned technical expert in chiral chemistry and biocatalysis with more than 18 years of extensive academic and industry experience. In recent years, his publications have centred on the economic and environmental benefits of “green” chemical methods, including biocatalysis, a direct and simple way to synthesise complex achiral and chiral compounds, and most recently innovations in continuous flow chemistry.

At Almac Sciences and Arran Chemical Company, Professor Moody is responsible for driving new technology processes from conception to commercial scale-up across multi-disciplinary research including enzyme engineering, biocatalysis, flow chemistry, isotope chemistry, custom synthesis and commercial production.

He previously held the role of Head of Biocatalysis and Isotope Chemistry, where he led the development of Almac Sciences’ Biocatalysis Technology platform selectAZyme^TM. He also played an integral role in the integration of Arran Chemical Company Ltd into Almac Sciences and ensured smooth transfer of manufacturing projects from Craigavon to the Arran site in Athlone, Ireland.

Professor Moody is a tenured honorary professor at Queens University Belfast in the area of Green Chemistry. In addition to his accolades in Chemistry including a Bachelor of Science (BSc) in Chemistry (First Class Hons) and a PhD in Organic Chemistry he holds a Master’s in Business with Distinction in Business Strategy.

Professor Moody commented, “At Almac Sciences, it is a fundamental value of our organisation to be innovative and share acquired technical knowledge that will advance our industry, particularly in areas that can reduce the environmental impact and cost of chemical production. I am grateful for the many opportunities I have received to share the innovative methods we’re developing with the wider industry and academic communities through publication and look forward to the continued opportunity to do so in the future.”

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Sciences Achieves Thought Leadership Milestone appeared first on Almac.

Almac Group Appoints Vice President of Small Molecule API

kelly — Wed, 07 Oct 2020 07:00:00 +0000

Craigavon, Northern Ireland – 06 October 2020 – Almac Sciences, a member of the Almac Group, has announced the appointment of Dan Bayston as Vice President of Small Molecule API.

Dan has been a key member of the company’s global Chemical Development and Scale-up team for the past 17 years. His unique knowledge, strong technical background and delivery track record has driven significant innovation in our service offering during this time and, in recent years, he has become increasingly involved in customer management, business performance assessment and business strategy.

Dr Stephen Barr, President & Managing Director, Almac Sciences, commented “Dan’s experience, credentials and working relationship with both his team, and the wider Business Unit, makes him a well-respected leader. This promotion is well deserved and I, and the rest of the Sciences’ Executive team, look forward to working with him in his new role.”

Prior to joining Almac in 2003, Dan completed a BSc at the University of Sheffield, a PhD at the University of Louvain-la-Neuve (Belgium) and held a Post-doctoral research position at the University of Oxford.

In addition, he has almost a decade of experience in various process development roles with a UK based chemical services company.

#ENDS#

About Almac Group

A unique culture delivering exceptional solutions

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Appoints Vice President of Small Molecule API appeared first on Almac.

Arran Chemical Company Continues Unique Industry – Academia Collaboration with Athlone Institute of Technology

davidkane — Tue, 08 Sep 2020 07:19:44 +0000

Announcing a new four-year PhD scholarship to deliver greener and more economic alternatives to chemical production methods

Athlone, Ireland, 08 Sept 2020 – Arran Chemical Company, a member of the Almac Group, has embarked on its second collaboration project with Athlone Institute of Technology (AIT) to support a four-year PhD programme which will investigate a novel library of Laccase enzyme biocatalysts in oxidative green chemistry.

Leading the project is Hong Ann Gan, the 2020 recipient of AIT’s President’s Doctoral Scholarship award. Hong recently completed a BSc (Hons.) in Medicinal Chemistry and Chemical Biology at UCD achieving a First-Class Honours Degree and will commence the project in October. Hong, originally from Malaysia, will be jointly supervised by AIT’s Dr. Sean Reidy, Lecturer in Chemistry, Dr. Noreen Morris, Lecturer in Chemistry, in collaboration with Professor Tom Moody, VP of Technology Development and Commercialisation, Almac Sciences & Arran Chemical Company and Dr. Peter Cairns, Technical Manager, Arran Chemical Company.

The project will focus on greener and more economic alternatives to chemical production methods for the synthesis of oxidative products which is currently an under resourced and studied area. This technology will find application in both pharmaceutical and fine chemical industries. Laccases are considered by many in the biotechnology field as the ultimate green catalyst due to the myriad of functional transformations, broad substrate specificity and relative autonomy due to the fact they only produce water as a by-product. In addition, the high stability, selectivity and mild reaction conditions, make these enzymes particularly attractive as oxidative catalysts for chemical synthesis. It is therefore essential that new methodologies are explored to expedite their use.

This Laccase project has the backing of Professor Moody, who commented: “We are delighted to be supporting AIT once again and look forward to working together over the next four years. Almac will supply the college with all the necessary biocatalysts needed for this investigation and, of course, guidance and expertise from our specialists in this field. We wish Hong every success in his PhD project.”

Dr Reidy stated “This project has the exciting prospect of exposing both the student and supervisors to new and exciting areas of research. A collaboration with Arran Chemical Company, an established global chemical company with a wealth of experience which works with clients globally, will raise the profile of Athlone Institute of Technology as a base of R&D excellence and lead to further opportunities for collaborative research in the future.”

AIT has established strong links with Arran Chemical Company over many years and, together, have carried out a variety of projects on the synthesis and separation of chiral amines. This project is the second such Academia – Industry collaboration between the Almac Group and AIT in recent years. The first project was initiated last summer and focused on the use of biocatalysis in the asymmetric synthesis of chiral amines and diamines. Lauryn Bracken, a recipient of AIT’s President’s Doctoral Scholarship award (2019), is undertaking this work as part of her PhD studies.

#END#

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Arran Chemical Company Continues Unique Industry – Academia Collaboration with Athlone Institute of Technology appeared first on Almac.

Almac Group “CATCH”es a SFI Industry Fellowship

davidkane — Wed, 22 Jul 2020 07:00:00 +0000

Collaboration with University College Dublin further expands its continuous flow platform

Craigavon, N.I., 22 Jul 2020 – Almac Sciences, a member of the Almac Group, “CATCH”es a prestigious Science Foundation Ireland (SFI) Industry Fellowship in collaboration with University College Dublin’s (UCD) flow chemistry specialist, Dr. Marcus Baumann. The Industry Fellowship Programme aims to enhance industry-academia collaborations through funding of research projects focused on knowledge exchange to drive excellence and innovation throughout Ireland.

CATCH – derived from continuous biocatalysed chemicals – underlines a commitment to develop new sustainable technologies that enables the competitive, and environmentally friendly, manufacture of chemical intermediates and active pharmaceutical ingredients (APIs) via the synergetic marriage of continuous flow and biocatalytic processes.

Upon winning the Fellowship, Dr. Baumann commented “This project will enhance my academic profile by extending my research portfolio into industrially relevant fields through close collaboration with a world leading industrial partner like Almac.”

Professor Tom Moody, VP Technology Development and Commercialisation at Almac Sciences and Arran Chemical Company further commented “The CATCH strategy will continue our commitment to exploit sustainable biocatalytic processes to synthesise chemicals in an on-demand flow fashion, thereby minimising the amount of by-products formed and demonstrating the synergies between our flow chemistry and biocatalysis platforms. Importantly, the CATCH project will continue to strengthen industrial and academic knowhow in this exciting field.”

Almac’s flow chemistry experts, Dr. Scott Wharry and Dr. Megan Smyth, are delighted to be working with Dr Baumann and his team at UCD. This news comes in addition to their existing collaboration with Queen’s University Belfast in the area of flow research (APPFlow), which secured a Horizon 2020 funded Innovative Training Network (ITN) Marie Skłodowska-Curie programme to support 4 PhD studentships over 4 years.

The expertise developed throughout this project will further expand Almac’s existing flow chemistry platform ensuring Almac continues to offer customers the best available technology to meet their demanding processing needs today, tomorrow and in the future.

ENDS

About Almac Group

To keep up to date with latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group “CATCH”es a SFI Industry Fellowship appeared first on Almac.

Almac Group Hosts Internationally Recognised Chemistry Forum in Belfast

admin — Fri, 01 Nov 2019 07:45:17 +0000

Newly coined Nordic-Irish Process Chemistry Conference Scheduled in May 2020

Craigavon, N.I., 01 November 2019 – Almac Sciences, a member of the Almac Group, is delighted to announce that the 2020 Nordic Process Chemistry Forum, an internationally recognised forum for leaders in chemistry, will be held in Belfast, Northern Ireland for the very first time in the forum’s history. Traditionally hosted by Nordic-based companies, this move has resulted in the forum being renamed to the Nordic-Irish Process Chemistry Forum in advance of the event.

As a leader in process chemistry and R&D, Almac Sciences will serve as the host during the forum in May. The Nordic Process Chemistry Forum has a long history of attracting some of the most respected and innovative speakers in the world of chemistry, and the Belfast event will be the 9th forum in an unbroken chain of biannual events.

Since the event was founded in 2004, the main driver of the forum has been to to bring scientists together who are involved in the design and scale up of chemical processes. The event facilitates networking, addresses pertinent chemical challenges, and fosters idea sharing and hosts new chemical trends. The upcoming event in Belfast is no exception— a fantastic line-up of industrial and academic speakers has been secured for this event, covering a range of subjects within the process chemistry field. A dedicated website has been created for this event (see below) and registration is now open with opportunities for participation.

Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company commented, “We have established excellent relationships with the Nordic Process Chemistry industry and are delighted to be entrusted to host this event in Northern Ireland. Almac knows, first-hand, of the rich chemistry expertise and innovative research taking place among industry and academia across theEU and our own island of Ireland and we are excited to showcase this at the event. We look forward to hosting our guests in Belfast where chemistry will be brought to life.”

Professor Hans-Jurgen Federsel, Founder of the Nordics forum, commented, “The basic idea behind starting the Nordic Process Chemistry Forum was the feeling that this part of the world was in dire need of a meeting ground where chemists, notably active in an industrial setting, could meet biannually and share top scientific and technical achievements. I’m personally very happy that my friends at Almac took on the task of organizing the 9^th consecutive event of this unbroken series and that we for the first time will be located outside the realm of the original Nordic countries.”

The Nordic Irish Process Chemistry Forum will be held from 12 – 14 May 2020 at the Titanic Quarter, Belfast, Northern Ireland. Visit the dedicated website here to register and download the agenda.

#END#

About Almac Group
A unique culture delivering exceptional solutions

The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Hosts Internationally Recognised Chemistry Forum in Belfast appeared first on Almac.

Arran Chemical Company forms Unique Industry – Academia Collaboration with Athlone Institute of Technology

admin — Mon, 08 Jul 2019 10:19:03 +0000

Four year PhD scholarship will deliver novel, greener chemical synthesis modalities

Athlone, Ireland, 08 Jul 2019 – Arran Chemical Company, a member of the Almac Group, has embarked on a unique collaboration project with Athlone Institute of Technology (AIT) to support a four year PhD programme which will see the use of biocatalysis in the asymmetric synthesis of chiral amines and diamines.

Leading the project is Lauryn Bracken who was the 2019 recipient of AIT’s President’s Doctoral Scholarship award. Lauryn, from Tullamore, County Offaly, Ireland, recently completed a BSc (Hons) in Pharmaceutical Science at AIT and will commence the project in October. She will be jointly supervised by Dr. Noreen Morris, Lecturer in Chemistry and Dr. Sean Reidy, Lecturer in Chemistry, AIT, in collaboration with Professor Tom Moody, VP of Technology Development and Commercialisation, Almac Sciences & Arran Chemical Company and Dr. Peter Cairns, Technical Manager, Arran Chemical Company.

The project will focus on greener and more economic alternatives to chemical production methods for the synthesis of chiral amines and diamines. Approximatively 80% of Active Pharmaceutical Intermediates (APIs) contain groups derived from amines. It is therefore essential that new methodologies are explored to expedite their synthesis.

The basic concept of the project is to displace multistep chemical routes currently used for the synthesis of chiral amines and diamines to simpler, lower cost and less polluting enzymatic processes. Biocatalysis offers an attractive approach for synthesis resulting in greener processes and real benefits for both the environment and overall cost of goods. General benefits of enzyme chemistry include use of water as a safe solvent, lower temperatures and selectivity that is unachievable by chemical methods.

AIT has established strong links with Arran Chemical Company over many years and, together, have carried out a variety of projects on the synthesis and separation of amines. This project has the backing of Professor Moody, who commented: “We are delighted to be supporting AIT once again and look forward to working together over the next four years. Almac will supply the college with all the necessary biocatalysts needed for this investigation and, of course, guidance and expertise from our specialists in this field. We wish Lauryn every success in her PhD project.”

Dr Morris stated “This project has the exciting prospect of exposing both the student and supervisors to new and exciting areas of research. A collaboration with Arran Chemical Company, an established chemical company with a wealth of experience which works with clients globally, will raise the profile of Athlone Institute of Technology as a base of R&D excellence and lead to further opportunities for collaborative research in the future.”

#End#

About Arran Chemical Company
Arran Chemical Company – a member of the Almac Group – is a fine chemical company specialising in the manufacture of products for pharmaceutical and health care, flavour/fragrance, personal care, and other specialised chemical and industrial applications.

We are specialists in chiral chemistry using both chemocatalysis and biocatalysis technologies, but also have practical operating experience over a wide range of modern synthetic reactions. We offer our clients superior chemical solutions with a high rate of success.

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Arran Chemical Company forms Unique Industry – Academia Collaboration with Athlone Institute of Technology appeared first on Almac.

Almac Group Engages with Science Exchange to Promote US Small Molecule Analytical Services

admin — Mon, 25 Feb 2019 07:55:49 +0000

Craigavon, N.I., 25 Feb 2019 – Almac Sciences, a member of the Almac Group, has announced a collaboration with Science Exchange, the world’s leading R&D Services Management company. The partnership will offer online access to Almac’s integrated services from development through commercial scale production of active pharmaceutical ingredients to clients worldwide.

Almac Sciences has profiled its service offerings on the Science Exchange website, including the recently announced full suite of analytical services now offered from its European and North American facilities. Employing 150 highly skilled analysts working in GMP / GLP environments, Almac is positioned as the partner of choice with significant experience in the analysis of both small and large molecules and a range of product types including peptides, biologics, conjugates, potents and controlled substances.

Science Exchange was founded in 2011 with the mission of democratising access to the world’s scientific expertise in order to move the research world forward at a faster pace. Science Exchange’s secure online solution to manage R&D services makes it easy for researchers to access the world’s leading scientific service providers and most innovative technologies.

“Science Exchange gives Almac Sciences another avenue where potential clients can find us in a quick and efficient manner,” says Denis Geffroy, VP Business Development, Almac Sciences. “This unique platform will enable us to provide added value across the clinical development lifecycle and help drive our clients to R&D success.”

Elizabeth Iorns, Ph.D., CEO and Co-Founder of Science Exchange, commented, “We are delighted that Almac has chosen to profile its offerings on our marketplace, where researchers from across the globe can readily access details on Almac’s vast range of services. Clients can use our platform to order services directly from Almac under a single, pre-established contract, enabling them to save time and money.”

###

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organization which has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn.

About Science Exchange, Inc.

Science Exchange is the world’s leading R&D Services Management company, empowering research organizations to accelerate science and drive more innovation success.

With a secure online solution to manage the complete R&D services eCommerce workflow, Science Exchange offers more than 7,000 services from a network of over 2,500 qualified research providers. For more information, visit www.scienceexchange.com.

The post Almac Group Engages with Science Exchange to Promote US Small Molecule Analytical Services appeared first on Almac.

Almac Group Flows into Continuous Technology

admin — Tue, 08 Jan 2019 01:10:20 +0000

Craigavon, N.I., 8 January 2019 – Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its Active Pharmaceutical Ingredients (API) services & chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company (Athlone, Ireland).

Continuous flow manufacture is an innovative technology platform which is gaining momentum within the pharmaceutical industry with the FDA supporting the adoption for the manufacture of APIs. It offers significant improvements in relation to product quality, process safety, reduction in plant footprint and provides the ability to perform chemistry that is difficult or impossible to do in batch mode.

Almac Sciences has a 4-year strategy to develop Flow Assisted Synthesis Technology (FAST) focusing on four key areas; (1) high pressure hydrogenations, (2) high energy chemistry, (3) oxidation and (4) photo-redox LED mediated chemistries. To support this, Almac Sciences has been awarded a Knowledge Transfer Partnership from Innovate UK for the development of novel routes to chiral amines using flow technology. In addition, Arran Chemical Company, in partnership with Queen’s University, Belfast, has been successful in securing a Horizon 2020 funded programme to support 4 PhD studentships for the next 4 years (beginning in 2019) in line with the FAST strategy.

Almac will develop highly flexible, robust, efficient flow technology platforms for continuous manufacture for the benefit of its clients who seek high quality and best-in-class pharmaceutical synthesis.

Prof. Tom Moody, VP Technology Development & Commercialisation, Almac & Arran Chemical Company commented, “The introduction of continuous flow technology further enhances Almac Sciences’ capabilities within API development and manufacture. Flow technology is highly flexible, robust, economic and regarded as the most exciting and innovative growth technology for the preparation of APIs. We are delighted to now offer this within our portfolio and will strive to continue providing world-class solutions to advance human health globally.”

###

About Almac Group

A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Flows into Continuous Technology appeared first on Almac.

Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

admin — Wed, 02 Jan 2019 09:51:01 +0000

Craigavon, N.I., 2 Jan 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce that they have brought online a second stream for High Throughput GMP Peptide manufacturing.

The High Throughput GMP Peptide facility, based in Edinburgh, Scotland, manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Almac has been active in High Throughput manufacturing of neoantigen derived peptides – branded by Almac as NeoPeptides™ – for several years. The NeoPeptides™ facility underwent a conversion from non GMP to GMP through 2018 and has been operating in full GMP mode since September. The facility has undergone a successful MHRA inspection and has now moved into routine GMP supply. Demand for Almac NeoPeptides™ is growing strongly and, in response, the company has moved quickly to bring online a second GMP manufacturing line.

Speed is critical within the field of individualised cancer vaccines and the entire supply chain is focused on minimising the time between the initial patient biopsy and the ultimate vaccine administration. Almac Sciences’ NeoPeptides™ offering is built upon Almac’s track record in high speed manufacturing of peptides from its Edinburgh facility. The key which has enabled Almac to convert this technical competence into High Throughput GMP manufacturing has been the creation and implementation of a bespoke Pharmaceutical Quality System, designed specifically to enable high speed, fully compliant GMP manufacturing. The company can already stand on its track record; in the first eight weeks of GMP operation the facility manufactured and released >80 GMP peptides.

Dr Charles Shields, Vice President Peptides and Small Molecule API commented “Almac’s decision to bring a second GMP NeoPeptides™ manufacturing stream online so quickly after the first is a clear statement of our commitment to the field of individualised cancer vaccines. We understand this market well and intend to maintain our world leading supply position on neoantigen derived peptides. We will be announcing further expansions of our facility and our service offering in the coming months.”

Neoantigen derived vaccines have become a major new strategy within oncology as researchers look to harness the body’s own immune system to fight cancer. The treatment platform is completely individualised. A patient’s tumour is biopsied and genetically sequenced to identify the epitope mutations which are present within the patient’s cancer. These neoepitopes are completely unique to that patient and their tumour. The neoepitopes are then replicated within a series of peptides – typically 10-30. The peptides are manufactured within Almac’s High Throughput GMP manufacturing facility, they are then formulated into a patient-specific cancer vaccine and administered to the patient. Each peptide manufacture is unique; manufacture occurs once and the product is administered to only one patient.

#END#

About Almac Group
A unique culture delivering exceptional solutions

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing appeared first on Almac.

Almac Group Launches Global Analytical Services Capability

admin — Mon, 01 Oct 2018 06:55:18 +0000

Craigavon, N.I., 01 Oct 2018 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce its global analytical services capabilities spanning UK, Europe and North America.

Following the successful acquisition of BioClin Research Laboratories in 2017, Almac’s Sciences Business Unit has united its world-class capabilities to form an analytical group which can meet the varying demands required within its clients’ development programs. From 1^st October, BioClin will rename under the Almac Sciences brand, further strengthening its offering and presenting a unified platform within the pharmaceutical industry.

Employing 150 highly skilled analysts working in GMP / GLP environments from its 3 locations in Craigavon, UK; Athlone, Ireland; and Souderton, Pennsylvania, North America, Almac is positioned as the partner of choice with significant experience in the analysis of both small and large molecules, and a range of product types including peptides, biologics, conjugates, potents and controlled substances.

In order to satisfy client demand, resource at Almac’s PA based facility has also increased by 30%. The 2,500 sq ft laboratory provides GMP analytical support to the pharmaceutical industry including analytical method development and validation, GMP stability studies and clinical and commercial product release.

Dr Stephen Barr, President & Managing Director of Almac Sciences, commented: “We are excited to present to the industry a unified analytical offering to our clients under the Almac name. The investments we continue to make highlights the commitment we have to our global client base to meet their growing clinical and commercial requirements.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

Almac would like to acknowledge and thank all those organisations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.

To keep up to date with our latest news, follow us on Twitter and LinkedIn.

The post Almac Group Launches Global Analytical Services Capability appeared first on Almac.

Almac Group Launches GMP High Throughput Peptide Manufacturing Service

admin — Fri, 27 Jul 2018 07:55:04 +0000

Craigavon, N.I., 27 Jul 2018 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce the successful MHRA registration of its High Throughput GMP Peptide manufacturing facility. Based at the Technopole campus near Edinburgh, Scotland, the facility manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Speed is critical within this therapeutic context as the entire supply chain is focused on minimising “needle to needle” time – i.e. the time between the initial patient biopsy and the ultimate vaccine administration. Almac Sciences’ experts have been associated with the individualised cancer vaccine field for several years and its facility and systems have been set up to enable fully GMP compliant manufacture and release of 20-30 GMP peptides within less than three weeks.

Almac has manufactured multiple High Throughput batches of neoantigen derived peptides –branded by Almac as NeoPeptides™ – for compassionate use treatments, and for P-I clinical trials, from its Edinburgh facility. Over the course of the past ten months the facility has been upgraded and segregated to enable GMP supply. A bespoke Pharmaceutical Quality System has been designed and implemented to enable high speed, fully compliant GMP manufacture. The systems have now been tested through a number of Pivotal Engineering Runs and have demonstrated robust performance and the ability to consistently achieve the less than three weeks peptide manufacturing target. GMP supply is expected to commence in Quarter 3, 2018.

Dr Charles Shields, Vice President Peptides and Small Molecule API, Almac Sciences commented “Almac is very excited to be at the leading edge of this revolutionary approach to immuno-oncology. The systems and capabilities we have established are world leading, but our vision goes beyond today’s performance and we already have clear plans for how to deliver higher capacity and faster manufacturing rates.”

###

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IVRS technology (IXRS®) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Launches GMP High Throughput Peptide Manufacturing Service appeared first on Almac.

Almac Group Appoints David Taylor as Head of Manufacturing Operations

admin — Tue, 01 May 2018 07:55:07 +0000

Craigavon, N.I., 01 May 2018 – David Taylor joined the Almac Group in November 2017 as Head of Manufacturing, Almac Sciences. He is tasked with the overall accountability for small molecule API and peptide manufacturing in Craigavon, and delivering on Almac’ Sciences’ supply chain operations at the Northern Ireland site. David has worked in the pharmaceutical and fine chemical industries for over twenty-two years, and brings with him a strong background in both the technical and manufacturing disciplines, allowing him to lead multidisciplinary teams to deliver streamlined operational outcomes. In an industry with significant emphasis on safety, quality and regulatory compliance, David has the skill set needed to anticipate and successfully communicate planning and procurement changes to customers, clients and third-parties abroad.

Dr Charles Shields, VP Peptides & Small Molecule API commented “We are delighted to welcome David to Almac. He clearly brings an impressive track record which is especially important to us as we continue to drive global sales and operational excellence. With his expertise and level of experience he will prove to be a great asset to our senior management team.”

After graduating from Newcastle Polytechnic and completing his PhD and post doctoral studies at the University of Sunderland, David worked as a chemist transferring fine chemicals and API manufacturing processes from lab scale through to full commercial scale. He transferred from R&D into manufacturing, leading large teams of shift operators for the cGMP manufacture of a range of APIs and registered intermediates on a top tier CoMAH site at ChiRex (now Sterling Pharma).

Following that, David gained experience in manufacturing, project and program management and has led teams to deliver projects in pre-clinical process development and multi gram synthesis to early phase multi kilo manufacture and through to late phase full scale process validation, product stability (full ICH study) and regulatory filing submission (DMF, CEP). He has worked at sites around the UK for Piramal Healthcare, Aesica and the Wasdell group.

David latterly gained senior leadership experience in drug product manufacture at Wasdell manufacturing (formerly SCM Pharma) and was accountable on the MHRA and Home office licences.

###

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

The post Almac Group Appoints David Taylor as Head of Manufacturing Operations appeared first on Almac.

Almac Group Appoints Dr Stefan Mix as Head of Biocatalysis

admin — Mon, 29 Jan 2018 09:00:55 +0000

Craigavon, N.I., 29 January 2018 – Almac Group, the global contract development and manufacturing organisation, has announced the appointment of Dr Stefan Mix to the position of Head of Biocatalysis, effective from 2 January 2018.

Stefan joined the Almac Sciences business in April 2005 as a chemist working in the lab on process development projects for chiral materials and has been part of the biocatalysis team since its beginnings. He has gained broad industrial experience including applications of biocatalysis, crystallisation development, process development for chiral building blocks and APIs, and technology transfer to manufacturing network partners, and was promoted to Biocatalysis Team Leader in 2012. All this time he has played a significant role in the development of Almac Sciences’ Biocatalysis Technology platform which has seen rapid growth and has multiple applications across a range of project scales and industry sectors.

In his new role, Stefan, who is the author of several publications will be responsible for the development and application of platform technologies within Almac Sciences leading a team of almost 50 scientists, in addition to supporting and directing commercialisation of new technology.

Stefan will report directly to Professor Tom Moody, VP Technology Development & Commercialisation, who congratulated him on his promotion: “Stefan’s wealth of knowledge, expertise and experience within biocatalysis and chemical synthesis has been critical to the success of our biocatalysis offering within Almac Sciences. I am delighted to announce Stefan’s promotion and wish him every success in his new role.”

Stefan was born in Berlin / East Germany, where he also completed his secondary education. After graduating with a Diploma in chemistry, he received his doctorate in 2004 from the Technical University of Berlin where he worked in a group under Professor Siegfried Blechert on stereoselective synthetic methodology and olefin metathesis.

###

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com

The post Almac Group Appoints Dr Stefan Mix as Head of Biocatalysis appeared first on Almac.

Almac Group Launches Bespoke Elemental Impurities Laboratory

admin — Wed, 24 Jan 2018 08:45:02 +0000

Craigavon, N.I., 24 January 2018 – The pharmaceutical industry is currently facing stringent new demands on elemental impurities from regulators stipulating the control and documentation of elemental impurities in drug products, drug substances and excipients. In response to these demands, Almac Group has announced significant investment in a state-of-the-art elemental impurities analysis laboratory at their European Headquarters, Craigavon, UK.

In compliance with USP <232 & 233>, EP (2.4.20) and ICH Q3D, all components, processes, packaging and final product must be risk assessed or tested for the presence of elemental impurities. Inductively coupled plasma mass spectrometry (ICP-MS) is widely recognised as the most suitable technique to meet the requirements of these, and future, regulatory requirements.

The new temperature controlled laboratory will incorporate industry-leading ICP-MS instruments; Thermo iCAP RQ C2 and Agilent 7900, in addition to MARS 5 and 6 microwave digesters. This investment enhances the existing well-established Almac ICP-MS testing service already available to clients.

Almac’s dedicated elemental impurities analysis team has already worked with many pharmaceutical companies to address the challenges of these new regulatory guidelines. A recent example was published in the Journal of Pharmaceutical and Biomedical Analysis: “Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP232/233” vol. 145, pp. 84–90, Oct. 2017.

“With this investment, we are in a position to fully support our global clients in both the pharmaceutical and biopharmaceutical sectors through the challenges of these new regulatory guidelines,” commented Dr Osama Chahrour, Leader of ICP-MS Services, Almac Sciences.

“Almac continues to invest heavily in state-of-the-art instruments and laboratories to meet the challenges of new regulations. This enables us to focus on fully supporting our clients through their drug development programs,” added Dr John Malone, Analytical Manager, Almac Sciences.

Almac Group

ENDS

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

To keep up to date with our latest news, follow us on Twitter and LinkedIn

The post Almac Group Launches Bespoke Elemental Impurities Laboratory appeared first on Almac.

Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

admin — Tue, 02 Jan 2018 08:55:53 +0000

Craigavon, N.I., 2 January 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce that they have brought online a second stream for High Throughput GMP Peptide manufacturing.

The High Throughput GMP Peptide facility, based in Edinburgh, Scotland, manufactures neoantigen derived peptides for use in the production of patient specific, individualised cancer vaccines.

Dr Charles Shields, Vice President Peptides and Small Molecule API commented “Almac’s decision to bring a second GMP NeoPeptides™ manufacturing stream online so quickly after the first is a clear statement of our commitment to the field of individualised cancer vaccines. We understand this market well and intend to maintain our world leading supply position on neoantigen derived peptides. We will be announcing further expansions of our facility and our service offering in the coming months.”

###

About Almac Group

‘A unique culture delivering exceptional solutions’

To keep up to date with our latest news, follow us on Twitter and LinkedIn or visit almacgroup.com.

The post Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing appeared first on Almac.

Almac Group Receives Annual Industrial Award from the Institute of Chemistry of Ireland

admin — Tue, 05 Dec 2017 08:30:36 +0000

Professor Tom Moody accepts accolade on behalf of Biocatalysis Team

Craigavon, N.I., 05 Dec 2017 – Almac Group, the global contract development and manufacturing organisation is delighted to announce Professor Tom Moody, VP Technology Development & Commercialisation at Almac & Arran Chemical Company, has received the prestigious Institute of Chemistry of Ireland Industrial Chemistry Award 2017.

Judges awarded Tom and his team with the honour based on the excellence demonstrated within Almac Sciences’ enzyme technology development research program. This is achieved through the unique collaboration between the biocatalysis team within Almac, headquartered in Northern Ireland, and Arran Chemical Company, Athlone, a member of the Almac Group since 2015.

The award was established to recognise the achievement of an individual chemist, or team of chemists, for making a significant contribution to the chemical or pharmaceutical industry in Ireland and the recipient is invited to present during the annual Eva Philbin Lecture – a series of keynote lectures in education institutions across Ireland. Eva Philbin was the first woman president of the Institute of Chemistry of Ireland. She began her career as a chemist in industry in 1939, and was chief chemist at two commercial companies before joining the chemistry department at University College Dublin in 1945.

Professor Moody presented his lecture on the subject of “Enzyme “feeds” rapid development and commercialisation” during the award ceremony held at the Albert Lecture Theatre, Royal College of Surgeons in Dublin, Ireland on 4^th December.

Tom leads a team of biocatalysis experts and is a distinguished chemist with an international reputation. He graduated from The Queen’s University Belfast with a 1st Class BSc(Hons) in chemistry before returning to gain a Ph.D. in Physical Organic chemistry. He has also completed a Masters Degree in Business graduating with distinction specialising in business strategy. His work has earned him numerous accolades and is co-author and author of >60 publications and patents. He is also an honorary Professor at Queen’s University of Belfast in the area of biocatalysis.

Upon receiving the award Professor Moody commented: “On behalf of the team at Almac Sciences and Arran Chemical Company, I am thrilled to receive this prestigious award. It is a true honour to be recognised in this way by the Institute of Chemistry and be invited to present a lecture in honour of Eva Philbin who is undoubtedly one of the most inspirational chemists of our lifetime. Special thanks to my entire team for their dedication, commitment and passion which has made winning this award possible.”

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The post Almac Group Receives Annual Industrial Award from the Institute of Chemistry of Ireland appeared first on Almac.

Almac Group Appoints Professor Tom Moody as VP of Technology Development and Commercialisation

admin — Tue, 13 Dec 2016 15:07:35 +0000

Craigavon, N.I., 12 December 2016 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Professor Tom Moody to the position of VP Technology Development and Commercialisation within Almac Sciences, effective from 1 December 2016.

Tom joined Almac in October 2001, moved into management in 2008 and has held the position of Senior Manager for the last 4 years operating in his role as Head of Biocatalysis and Isotope Chemistry. Over this time he has led the development of Almac Sciences’ Biocatalysis Technology platform which has seen rapid growth and has multiple applications across a range of project scales and industry sectors.

In the last year he has played an integral role in the integration of Arran Chemical Company Ltd into Almac Sciences and ensured smooth transfer of Biocatalysis manufacturing projects from Craigavon to the Arran site in Athlone, Ireland.

In his new role, Tom will be responsible for the development and application of platform technologies within both the Sciences and Arran businesses, in addition to supporting and directing commercialisation of new technology. He will have direct operational responsibility for the Biocatalysis and Isotope Chemistry businesses and the R&D function within Arran.

Tom will report directly to Dr Stephen Barr, President & MD, Almac Sciences who congratulated him on his promotion:

“Tom’s considerable expertise and experience within biocatalysis and chemical synthesis has been crucial in developing the Sciences, and more recently, Arran businesses. In addition, his ability to form incredibly strong relationships with our clients has been critical to the growth and success of these particular service offerings. I am delighted to announce Tom’s promotion to VP and wish him every success in his new role.”

Tom holds a Masters in Business with Distinction in Business Strategy, a PhD in Organic Chemistry and a Bachelor of Science (BSc) in Chemistry (First Class Hons).

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

https://www.almacgroup.com

The post Almac Group Appoints Professor Tom Moody as VP of Technology Development and Commercialisation appeared first on Almac.

Almac Group Wins Prestigious Research and Development Award

admin — Fri, 14 Oct 2016 06:57:35 +0000

Craigavon, N.I., 14 October 2016 – Almac Group, the global contract development and manufacturing organisation is delighted to have won the coveted Research and Development achievement award at this years’ Pharma Industry Awards.

The annual event aims to recognise and celebrate the most original and innovative individuals and companies that demonstrate excellence within the Irish Pharma sector and the glittering awards ceremony took place in the Ballsbridge Hotel, Dublin on the evening of Thursday 13^th October.

Almac received the award for demonstrating its excellence in enzyme technology development through their “selectAZyme™” research program. This is achieved through the unique collaboration between the biocatalysis team within Almac’s Sciences business unit and Arran Chemical Company which was acquired by the Almac Group in November 2015. The “selectAZyme™” program is centred around Almac’s enzyme platform which delivers a diverse A-Z range of enzymes for development and scale-up within medicinal chemistry, metabolite synthesis and specialty chemicals for large scale manufacturing projects.

An independent panel of recognised and expert individuals within the pharmaceutical sector judged the entries and determined the winners based on a number of key attributes. Almac beat off stiff competition and clearly demonstrated its team integration, innovation, increased business performance, skills benefit to the Northern Irish and Irish economies plus the environmental benefits associated with biocatalysis technology to pick up the prestigious trophy.

Professor Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac & Head of Technology at Arran Chemical Company commented “This award further demonstrates the combined capability, expertise and experience of the Almac and Arran Chemical Company teams. We are delighted to be recognised at the Pharma Industry Awards and pride ourselves on our ability to provide high quality, flexible and innovative solutions to meet our global clients’ requirements.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

https://www.almacgroup.com

The post Almac Group Wins Prestigious Research and Development Award appeared first on Almac.

Almac to partner with ZYMtronix to deploy its universal enzyme immobilisation platform

admin — Mon, 23 May 2016 08:37:49 +0000

ZYMtronix and Almac are collaborating on a National Science Foundation (NSF) sponsored project focusing on the stabilisation and immobilisation of metabolic enzymes for biooxidation applications. These enzymes have the potential to be powerful tools for accessing difficult to synthesise drug metabolites and oxidation products. However, they can be relatively unstable under chemical processing conditions and difficult to use in production.

“Almac is the ideal partner for ZYMtronix to deploy its universal enzyme immobilisation platform to enhance Almac’s monooxygenase enzyme collection. The project will allow both companies to provide the industry with efficient immobilised catalysts for mild and selective oxidation of chemical intermediates and APIs with reduced production costs,” said Dr. Stéphane Corgié, CEO of ZYMtronix.

Professor Tom Moody, Head of Biocatalysis at Almac commented:

‘We look forward to adding ZYMtronix technology to our expanding biocatalysis capabilities. Although monooxygenases have great potential for efficient synthesis of otherwise difficult to access products, implementation has been limited by slow reaction rates and need for high enzyme loadings. ZYMtronix technology has the potential to overcome these limitations.’

About Almac Group

‘Partnering to Advance Human Health’

Almac Group has supported the global biopharmaceutical industry with their drug development activities and bringing new drugs to market to advance human health for more than 40 years. Privately owned and headquartered in Craigavon, Northern Ireland, the company employs in excess of 4,000 personnel in the United Kingdom, United States and Asia. Almac’s commitment to quality is guaranteed through a comprehensive range of standard operating procedures and fully documented quality systems developed in accordance with global pharmaceutical guidelines. Almac’s research targets five main branches: diagnostics, sciences, clinical services, clinical technologies and pharmaceutical services. The Almac Biocatalysis group, led by Prof. Tom Moody, consists of computational, molecular- and microbiologists, enzymologists, organic chemists and analysts; the group has demonstrated expertise in gene identification, expression, enzyme evolution, fermentation, enzyme production and biotransformation scale-up. Expertise ranges from enzyme production to the synthesis of complex chiral APIs from milligram to ton scale.

About ZYMtronix

‘Biocatalysis in Motion’

ZYMtronix Catalytic Systems, Inc. (DBA ZYMtronix, Inc.) is a life science company formed in 2013 as a spin-off from Cornell University research. The company provides the industry – pharmaceutical and enzyme manufacturers – cost-effective solutions to maximize the use of enzymes in drug discovery and drug manufacturing. In traditional chemistry, making pharmaceutical drugs requires a long series of labor-intensive, expensive reactions, but employing immobilized enzymes cuts the number of necessary reactions and can reduce energy and the use of hazardous chemicals. The founders, Stéphane Corgié, PhD (CEO-CTO) and Juan Diego Alonso JD-MBA (CFO) are joined by Dr. Joseph Marasco who leads the company’s business development efforts as Chief Business Officer of Pharmaceutical Operations.

The post Almac to partner with ZYMtronix to deploy its universal enzyme immobilisation platform appeared first on Almac.

NEW Fluorescence Lifetime Platform Unveiled at SLAS

admin — Mon, 25 Jan 2016 16:01:58 +0000

Melbourn, UK, 20 January 2016. Combining their well-established expertise in drug discovery automation plus peptide and protein engineering and manufacture, TTP Labtech and Almac Group have formed a strategic partnership to bring you a fully integrated fluorescence lifetime platform. Being launched on Booth 621 at the Society for Laboratory Automation and Screening (SLAS) Conference in San Diego, USA the new platform comprises TTP Labtech’s new ameon^® lifetime reader and Almac’s FLEXYTE^® lifetime assays and reagents for precise lifetime assays, to provide a simple one-stop shop for robust, cost-effective drug screening and profiling.

On the booth, the new compact ameon lifetime reader will be on show which offers a step-change in lifetime data acquisition. Experts will also be on hand to explain how the reader can be combined with FLEXYTE lifetime reagents for the screening of common drug targets such as protein kinases and proteases, as well as challenging epigenetic targets. Applying such a powerful combination allows researchers to reduce compound-related assay interference, select fewer false leads and obtain the reliability normally associated with biophysical methods at the compound screen stage.

For scientists wanting to find out more about the unrivalled advantages of this accessible lifetime technology, there is a lunch tutorial entitled “An exciting talk: use of fluorescence lifetime technologies for high-throughput protein kinase screening and profiling” delivered by leading industry speakers on Monday 25th January from 12.30-13.15 in Room 1A. Please click the link to register https://discover.ttplabtech.com/SLAS-2016-lifetime-workshop.html. There are also poster presentations from AstraZeneca and GlaxoSmithKline detailing their recent experience with the platform.

Dr Wayne Bowen, CSO at TTP Labtech, stated: “We have listened, and in partnership with major pharma companies, have developed an intelligent approach to improve the efficiency of compound screening. Most screening methodologies continue to be impacted by too many false hits and the limited throughput of orthogonal biophysical technologies; the intrinsic robustness of Almac’s FLEXYTE lifetime reagents coupled with the precision of TTP Labtech’s new ameon lifetime reader sets a new benchmark for cost-effective screening through better discrimination of lead compounds at an earlier stage within the drug discovery process.”

Dr Charles Shields, VP of Peptides & Small Molecule API at Almac commented: “We believe that the strategic partnership between TTP Labtech and Almac will bring to the screening community a true step-change in assay performance with the ability to uncover previously obscured leads and the potential to access new chemical space.”

About TTP Labtech – natural innovators

From its global headquarters based near Cambridge, UK, TTP Labtech creates, designs and manufactures robust and innovative automated laboratory instrumentation and consumables for both the academic and industrial sectors of pharmaceutical and biotech research.

TTP Labtech is part of TTP Group plc, a company that originated from The Technology Partnership (TTP) which is Europe’s leading independent centre for innovation. Since 2002, TTP Labtech has successfully combined cutting edge science with first rate engineering. Innovation is at the core of the company and is illustrated by the passion and expertise of its personnel and evidenced by the novel products and technologies that are brought to market.

TTP Labtech provides state-of-the-art solutions developed for specific product areas: cell-based screening (acumen Cellista^®, mirrorball^®); sample management (comPOUND^®, arktic^®, lab2lab) and low volume liquid handling (mosquito^®, dragonfly^®).

For further information, please visit www.ttplabtech.com.

About Almac Group – ‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS^® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For further information, visit almacgroup.com or e-mail media@almacgroup.com.

The post NEW Fluorescence Lifetime Platform Unveiled at SLAS appeared first on Almac.

Almac Acquires Arran Chemical Company and Expands Biocatalysis Services

admin — Tue, 03 Nov 2015 13:56:56 +0000

Craigavon, N.I., UK, – 03 November 2015 – Almac Group, the global contract development and manufacturing organisation, today announced the acquisition of 100% shares of Arran Chemical Company, an independent and privately owned organisation based in Athlone, Ireland.

The addition of Arran Chemical Company marks a new chapter in Almac’s continuous growth, with significant increase in scale (a range of reactors up to 6,300L and total capacity of up to 45m³) the new combined business will integrate Biocatalysis technology with large scale intermediates manufacture.

Located in County Roscommon, just two hours away from Almac Group’s Headquarters, the existing Arran Chemical Company specialises in the manufacture of products for the pharmaceutical, flavour/fragrance, personal care and other specialised chemical and industrial applications. Both companies have more than 25 years’ experience and have been working together closely on multiple projects over the past 5 years.

The bespoke facility offers a full range of scales including kg lab, multi-purpose pilot plant and manufacturing plant. Arran’s assets strongly complements Almac Sciences’ existing business and will allow both entities to continue growing in their respective market.

“This is a very exciting opportunity for both Almac and Arran Chemical Company.” said Dr Stephen Barr, Managing Director, Almac Sciences. “Based on our combined strength, scale and technology, we will offer commercial products and pharmaceutical intermediates using our current world leading Biocatalysis technology platform enabling us to address our global clients’ growing demands for a high quality, integrated, efficient service and we are delighted to be able to support our clients in this way.”

Anthony Owens, Managing Director, Arran Chemical Company commented “We are very pleased with this significant development which enables us to continue to deliver high quality products to our global customer base in addition to offering a broader range of solutions. This move builds on our established presence in the industry and we look forward to merging our expertise and experience with Almac’s undoubted success to match the increasing requirements of customers across the whole spectrum of the industry.”

About Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 3,900 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit almacgroup.com or e-mail media@almacgroup.com.

The post Almac Acquires Arran Chemical Company and Expands Biocatalysis Services appeared first on Almac.

Almac Group Appoints Dr. John Robson as VP Quality Operations

admin — Fri, 10 Jul 2015 11:14:25 +0000

Craigavon, UK – 07 Jul 2015 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Dr. John Robson to the position of Vice President Quality Operations for its Sciences’ Business Unit.

Dr. Robson will be responsible for the operation of their analytical services business and overseeing quality across their sites located throughout the UK and US. In addition to his direct operational responsibilities, he will also be an integral member of the senior leadership team, focusing on strategy development and implementation to expand and grow their global operations.With over 20 years of experience in a number of business leadership, quality and analytical roles Dr. Robson joins Almac directly from Lonza Biologics where he held the position of Global Head of Analytical Services. Prior to this, he served as Vice President and General Manager, Early Development at Covance, and Global Head of Bioanalytical Services at MDS Pharma Services.

Dr. Robson holds a PhD in Analytical Chemistry from the University of Plymouth in addition to a BSc in Environmental Chemistry and also holds an MSc in Organic Geochemistry from Newcastle University.

“John has an impressive track record and will bring a wealth of industry experience to the existing Management team. We are delighted to have him join us.” said Dr. Stephen Barr, Managing Director of Almac’s Sciences business unit.

The post Almac Group Appoints Dr. John Robson as VP Quality Operations appeared first on Almac.

Almac Group Drives Biocatalysis Leadership with a Further $7M Investment

admin — Thu, 05 Feb 2015 11:48:03 +0000

Craigavon, UK, February 2, 2015 – Almac Group, the global contract development and manufacturing organization, today announced a $7 million investment in a significant collaborative research and development expansion with Queens University Belfast (QUB) supported by Invest Northern Ireland in the area of biocatalyst discovery and development.

The ground-breaking project involves the further development of the Group’s biocatalysis services and will enable the team to build upon their considerable existing expertise.

The 3 year development programme will be in conjunction with QUB to provide new, best-in-class biocatalyst platforms and products for the global active pharmaceutical ingredient, flavour & fragrance, agrochemical and fine chemical sectors.

The investment will establish a unique dedicated biotechnology research team who will accelerate the development of bioinformatics, molecular modelling and enzyme evolution. This will facilitate the introduction of faster and superior methods to access novel enzymes with unique properties that are required for scale-up chemistry.

“The biocatalyst is the future for scale-up chemistry involving chirality as it provides efficient, clean and robust processes. The $7m R&D investment demonstrates Almac’s continued commitment to biocatalysis, supporting further growth in our expertise and capabilities in biotechnology”. Notes Head of Biocatalysis Professor Tom Moody.

Dr Chris Allen, Senior Lecturer in the School of Biological Sciences is Principal Investigator on the grant at QUB. He said: “Biocatalysis and industrial biotechnology are now becoming critical drivers in both the local and global economies. This research project will help to build the knowledge base and expertise in these fields for both Almac Sciences and QUB. The project also demonstrates how different subject areas in QUB – in this case Biological Sciences and Chemistry – can be combined to develop exciting new research opportunities.”

Other academic staff involved are Dr Meilan Huang (School of Chemistry & Chemical Engineering) and Dr Leonid Kulakov (School of Biological Sciences).

Invest NI has offered Almac Group £1.5 million of research and development assistance, this project is part-financed by the European Regional Development Fund under the Investment for Growth and Jobs Programme 2014-2020.

Jeremy Fitch, Invest NI’s Executive Director of Business Solutions said: “This investment in collaborative research and development is good news for Northern Ireland’s growing life sciences sector and will help to strengthen Almac’s expertise in biotechnology.

“Almac has a reputation for excellence in the international pharmaceutical sector and this latest R&D investment will ensure that it remains in a competitive position and can continue to meet the needs of its global client base.”

Stephen Barr, Managing Director, Almac’s Sciences business unit commented: “Today’s announcement is the latest in a series of investments made by Almac over recent years and represents our commitment to building and sustaining an innovative service offering to satisfy growing client demand. We very much look forward to working together with our clients on this exciting project”

The post Almac Group Drives Biocatalysis Leadership with a Further $7M Investment appeared first on Almac.

Almac wins Laboratory Team of the Year at The Irish Laboratory Awards 2013

admin — Tue, 10 Dec 2013 09:44:12 +0000

Almac‘s Enzyme Research and Development team have been recognised at The Irish Laboratory Awards by winning “Laboratory Team of the Year.”

The awards, the first of their kind in Ireland, were held to recognise the success and achievements of Ireland’s internationally renowned scientists in areas including innovation, leadership and collaboration, and focus on the on-going work of Irish scientists to grow and develop sustainable, globally competitive science research.

The 30-strong Almac Biocatalysis Team has been at the forefront of innovation and solutions to a large number of Pharmaceutical companies and API manufacturers across the world. Enzymatic technology is increasingly displacing chemical processes, yielding a higher quality product at a more attractive price while making significant benefit to the environment.

Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac commented, “Our team is recognised globally as a key player in the area of biocatalyst research and development and we are delighted to have won this award.”

“It is now acknowledged that the need for green, economic, robust and scalable processes is at the forefront of customer research plans for the synthesis of chiral APIs and intermediates. This award demonstrates our continued success in this field, and the Enzyme Research and Development team is a key to our future.”

The post Almac wins Laboratory Team of the Year at The Irish Laboratory Awards 2013 appeared first on Almac.

Almac’s Strengthened Facilities Accommodates Demand of Late Stage API Manufacture

admin — Wed, 13 Nov 2013 11:04:06 +0000

Almac is pleased to report that the expansion of its API manufacturing facilities has allowed significant growth in its late stage manufacturing service.

The facility upgrade included installation of two 1,000L reactors and state-of-the-art pressure filter dryer, which now allows production of highly potent API manufacture up to 500kg with a dedicated nitrogen jet mill for micronisation.

Denis Geffroy, VP Business Development, commented: “Over the past few years, Almac’s API business has continued to grow at a double digit pace. The facility expansion was much needed and the results are already striking with several Phase III and Commercial projects awarded.”

Almac’s clients also leverage Almac’s API and Drug Product integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines whilst maintaining scientific continuity. This year Almac has completed its first joint commercial API and Drug Product manufacture which demonstrated the advantages of integrated operations.

“Today, our API business is made of 30% late phase and commercial projects, compared to just 5% 3 years ago, which gives a clear indication that our strategy to invest through expansion was the right one.” added Denis.

Notes to Editors

About Almac

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

The post Almac’s Strengthened Facilities Accommodates Demand of Late Stage API Manufacture appeared first on Almac.

Novozymes Biopharma announces collaboration with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies

admin — Tue, 22 Oct 2013 08:07:04 +0000

Combined service offers drug development companies efficiencies in time and resource

Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, is delighted to announce its new collaboration with Almac, to provide a combined service for drug development applications in the field of drug targeting and pharmacokinetic improvements. The collaboration will allow clients to utilise Almac’s world-class manufacturing assets and protein conjugation capability to link Novozymes’ Recombumin® Flex technology successfully to their peptide and small molecule drugs. This subsequently improves the pharmacokinetics and has already been shown to improve drug targeting in oncology and rheumatoid arthritis. Collaborations with commercial partners have already begun and will continue to expand in early 2014.

Novozymes and Almac have a solid history of cooperation in peptide and small molecule conjugation projects. The formalisation of this collaboration offers drug developers the immediate benefit of continuity of service provision through the stages of clinical development -delivering efficiencies in time and internal resource, whilst increasing the chances of clinical success. Clients will also benefit from extensive experience in product and service provision to the pharmaceutical industry with access to a comprehensive level of both technical and regulatory support.

Novozymes’ Recombumin® Flex technology will be the focal point of this collaboration. Novozymes has modified the amino acid sequence of human albumin to increase its receptor affinity, providing novel properties including improved half-life extension and drug targeting. This technology naturally complements Almac’s expertise in peptide and small molecule manufacturing, and can also be allied to its world-class protein conjugation technology offerings. As a result, clients will be able to successfully use Almac’s technology to link Recombumin® Flex to their drug products as part of one contract service offering.

“By working alongside Almac, we are confident that we will be able to create more opportunities for developers seeking to benefit from the Recombumin® Flex technology.” stated Dermot Pearson, Marketing Director at Novozymes Biopharma. “The advantage of working with two companies well versed in providing products and services to the pharmaceutical industry is that customers gain the assurance that their needs will be provided for, not just in the short term, but right through to commercial supply.”

Denis Geffroy, VP Business Development for Almac stated: “This alliance has clear benefits for companies involved in both drug development and delivery technologies: a complete service can be recommended utilising the core expertise of both parties at an early stage of clinical development, thus significantly enhancing the success of drug development programmes.”

Both Almac and Novozymes Biopharma will be exhibiting at CPhI WorldWide: Almac in Hall 4.2 L08, and Novozymes Hall 6.2 62E47.

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers’ business and the use of our planet’s resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Contact:

Novozymes Biopharma:

Sally Vernon, Marketing Communications Manager

Email:SYKE@novozymes.com>

Tel. +44 115 955 3355

MEDIA CONTACTS

INVESTOR CONTACTS

Europe René Tronborg

Office: +45 4446 2274

Mobile: +45 3077 2274

retr@novozymes.com

USPaige Donnelly

Office: +1 919 494 3209

Mobile: +1 919 218 4501

pagd@novozymes.com

ChinaZhu Xiaoqing

Office: +86 106 298 7888+362

Mobile: +86 138 012 40590

xqzh@novozymes.com

BrazilAna Cecilia Amarante de Oliveira

Office: +55 41 3641 1096

Mobile: +55 41 9619 7594

aaov@novozymes.com

USThomas Steenbech Bomhoff

Mobile: +1 919 649 2565

tsbm@novozymes.com

About Almac

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland, with US operations based in Pennsylvania, North Carolina and California.

To learn more about Almac please visit almacgroup.com, e-mail info@almacgroup.com or follow us on Twitter at https://twitter.com/AlmacGroup.

Contact:

Almac:

Denis Geffroy, VP Business Development

Email:denis.geffroy@almacgroup.com

Tel. +44 2838 332200

Contact:

De Facto Communications

Tristan Jervis

E-mail : T.Jervis@Defacto.com

Tel: 00 44 207 861 3019

Mobile: 00 44 771 363 8396

The post Novozymes Biopharma announces collaboration with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies appeared first on Almac.

Almac Launches New [14C]-labelled ADCs Service Offering

admin — Mon, 07 Oct 2013 09:00:37 +0000

Almac has today announced the launch of a new offering for the provision of [14C]-labelled Antibody Drug Conjugates (ADCs).

In recent years the interest in antibody drug conjugates for the targeted treatment of various cancer types has grown massively, and the need for evaluation of the pharmacokinetic profile of these ADCs is becoming more important. Radiolabelling of drugs remains the most effective methodology to facilitate absorption, distribution, metabolism and excretion (ADME) studies, and therefore [14C] labelling of ADCs is becoming a critical part of their development.

The [14C] label is typically placed on either the active drug or the linker moiety, or can be incorporated into both.

Almac’s expertise in this area comes from the integration of biology, chemistry, peptide and purification science, analytical and quality disciplines within their isotope laboratories. The ability to deliver labelled linkers, payloads and complete the bioconjugation within one team shortens timelines and results in a more cost effective solution to clients.

Dr Tom Moody, Head of Biocatalysis and Isotope Chemistry at Almac commented: “As ADCs become more prevalent in drug development, our isotope expertise and technology has kept pace with our customers’ needs. Almac are in the unique position for the provision of all the services required to manufacture [14C] labelled ADCs and this can make a real difference to First in Human study programmes.”

Dr William Watters, Almac’s Isotope Manager added: “The merging of our Biocatalysis and Isotope Chemistry groups, coupled with the presence of an experienced Peptide Synthesis team, ensures that we have the right technical mix to successfully deliver on these complex projects.”

Almac has vast experience in the synthesis of [14C] labelled small molecules, peptides, linkers, and ADCs to both non-GMP and cGMP standards. Almac was also awarded a license by the MHRA in 2009 for the manufacture of [14C] radiolabelled drug product.

The post Almac Launches New [14C]-labelled ADCs Service Offering appeared first on Almac.

Almac Receives FDA Inspection Approval

admin — Wed, 20 Feb 2013 10:03:02 +0000

Following from successful MHRA audits in 2011, Almac’s Sciences Business Unit has completed a successful inspection of its analytical facilities at its Craigavon Headquarters, Northern Ireland from the US Food and Drug Administration (FDA). The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements.

The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences are named as the contract test laboratory. The 3-day inspection covered the Quality and Laboratory Control systems and included tours of all test laboratories and specialist analytical facilities including mass spectroscopy laboratories. .

Commenting on the approval, President and Managing Director, Stephen Barr said:

“We are delighted with the outcome of this inspection. We have now established a track record with both authorities which highlights our strong focus on compliance and regard for regulatory standards. This outcome is even more significant with the completion of our expanded API facility, and focus on late phase clinical development projects. Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.”

Alan Chambers, Head of Quality Assurance added,

“This success confirms Almac’s dedication to delivering the highest quality standards. To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce. We are committed to building on these strong foundations with continual investment within our quality systems.”

Almac is also pleased to announce expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP Active Pharmaceutical Ingredients (API) manufacturing capacity, and expansion of its stability storage chambers with also a doubled capacity increase.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Almac Receives FDA Inspection Approval appeared first on Almac.

Almac Successfully Completes Knowledge Transfer Partnership with Queens University with Highest Accolade

admin — Mon, 21 Jan 2013 09:47:28 +0000

Almac is pleased to announce the successful completion of the Knowledge Transfer Partnership (KTP) with Queens University, Belfast to develop, improve and embed bioprocesses in order to facilitate the delivery of novel products for its biocatalysis business. The project was awarded the highest grade of “Outstanding” by the KTP Grading Panel for it’s achievement in meeting KTP’s objectives.

The overall partnership aim was to allow technology transfer of fermentation and molecular / microbiology expertise from Queens University to Almac. Almac met the specific partnership objectives by not only sharing a program of work with academics at Queens, but also attending training courses organised through University College London and embedding key learning back into the company.

The resulting success of this collaboration is that Almac can now deliver a fully integrated fermentation, optimisation and bio-product service to its customers. Since completion of the KTP, Almac have successfully scaled fermentation and bio-oxidation reactions to thousands of litres.

Dr Tom Moody, Head of Biocatalysis and Radiolabelling Services, is understandably delighted with the results of this partnership: “To receive the highest grade of Outstanding is a huge achievement for Almac, and testament to the commitment of the team involved. Not only have we further strengthened our long-standing relationship with Queens University, but we have also increased our service offering within the biocatalysis field to our clients, thus allowing us to compete in an area which was previously beyond our reach.”

This achievement follows from an extremely successful year for Almac’s biocatalysis service offering. 2012 saw the launch of its metabolite synthesis services, winning a Belfast Telegraph Award in Excellence in Technology, and announcing an industry-leading biocatalysis collaboration with DSM Pharmaceutical Products.

Notes to Editors

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Almac Successfully Completes Knowledge Transfer Partnership with Queens University with Highest Accolade appeared first on Almac.

Almac and TTP Labtech form alliance in fluorescence lifetime technology

admin — Mon, 07 Jan 2013 09:55:25 +0000

Combining cutting edge science with first rate engineering

FLEXYTE™ assays harness the power and potential of fluorescence lifetime technology

Almac and TTP Labtech announced today the formation of an alliance in the field of fluorescence lifetime (FLT) technology to provide class leading screening performance. This will give customers of either party access to a broad range of biological applications coupled with the next generation of microplate reader technology.

FLT as a reading modality offers a robust, antibody-free, homogeneous assay platform which enables the user to avoid interference from fluorescent compounds within a screening library. Developed utilising experience in peptide engineering and chemical synthesis and design, Almac’s FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling. The evolving assay platform offers solutions for many major therapeutic target classes including kinases, proteases, phosphatases, DUB and an increasing number of epigenetic targets.

TTP Labtech’s Ameon™ system represents the next generation of FLT reader technology. By offering real-time decay curve analysis, the Ameon™ system provides a revolutionary combination of speed, precision, and data quality for FLT assays that can be readily integrated into HTS workflows.

‘The development of the Ameon™ reader by TTP Labtech has introduced an exciting new dimension to FLT technology and we are pleased that Almac’s FLEXYTE™ customers will be able to benefit from this advance in reader technology’ said Dr Stephen Barr, President and Managing Director of Almac Sciences.

‘We are excited by the potential of the FLEXYTE™ and Ameon™ reader combination to deliver robust, cost-effective screening results and enhanced productivity through better discrimination of lead compounds’ said Dr Wayne Bowen, Chief Scientific Officer of TTP Labtech.

Video Interview:

Wayne Bowden from TTP Labtech tells SelectScience how this alliance will give customers access to a broad range of biological applications coupled with the next generation of microplate reader technology. Wayne also tells us more about TTP Labtech’s Ameon™ system, which represents the next generation of FLT reader technology. In addition Robert Grundy from Almac discusses how FLEXYTE™ assays harness the power and potential of FLT to provide an efficient and economical platform for screening and profiling. Click here to view

Editors’ notes

About Almac

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About TTP Labtech Limited

Based near Cambridge, UK, TTP Labtech creates, designs and manufactures robust, reliable and easy-to-use instrumentation to offer life scientists better tools and techniques, simplifying complex operations, saving time and material costs.

We provide state-of-the-art solutions developed for specific product areas including: cell-based screening (acumen^®, mirrorball^®); sample management (comPOUND^®), low liquid handling (mosquito^®) and the management of analytical automation (lab2lab).

TTP Labtech is owned by its employees, and our continued drive to innovate combines cutting edge science with first rate engineering, manufacturing and outstanding customer support.

For further information please visit www.ttplabtech.com

The post Almac and TTP Labtech form alliance in fluorescence lifetime technology appeared first on Almac.

Almac Concludes Commercial API Manufacturing Facility Expansion Plans

admin — Tue, 09 Oct 2012 08:11:35 +0000

In response to client requirements, Almac’s expansion of their API manufacturing facility at its European Headquarters in Craigavon, UK is near completion, and will be operational by the end of the year. This upgrade includes installation of two 1,000L reactors and state-of-the-art pressure filter dryer, which allows production of GMP Active Pharmaceutical Ingredients (API) up to 150kg batch size.

Almac’s strategy to increase market share in late phase clinical development is reaping rewards, and clients are already seeing the advantages of having one constant manufacturing partner through each phase of clinical development. “Almac’s investment has further demonstrated our goal of being the outsourcing partner of choice through all stages of clinical development.” stated Denis Geffroy, VP Business Development. “We are delighted to have the scale to share the manufacturing journey with our clients from preclinical phase to full commercialisation.”

Clients can also leverage Almac’s API and Drug Product integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines whilst maintaining scientific continuity. Almac’s advantage of hosting all facilities on one site have led to the successful technology transfer of small molecule and peptide projects from lab development to large scale manufacture.

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 10E41) and AAPS (Booth 3027) conferences.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Concludes Commercial API Manufacturing Facility Expansion Plans appeared first on Almac.

Almac and DSM Sign Collaboration Agreement in Biocatalysis

admin — Mon, 08 Oct 2012 08:27:25 +0000

Almac is delighted to announce a collaboration agreement with DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), in the field of biocatalysis to provide sustainable manufacturing services to the pharmaceutical industry.

The agreement grants both parties access to their enzyme platform technologies, services and expertise for the manufacturing of active pharmaceutical ingredients (APIs). Almac’s expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale. This will give customers of either party access to enzyme expertise and assets resulting in cost-effective, green processing at all phases of development from preclinical to commercial manufacturing scale. This collaboration will also enable Almac to offer its customers a preferred partner for large-scale production.

Alexander Wessels, CEO of DSM Pharmaceutical Products, stated, “Working with the Almac Group marks further advancement of DSM’s stated strategy towards strategic partnerships to excel in providing new customer solutions. DSM is a global leader in applied biocatalysis, providing high quality custom manufacturing and development services to the pharmaceutical and biopharmaceutical industries. Via this agreement, we maintain our commitment to the future of pharma manufacturing, adding to our green chemistry toolbox, which also includes complex chemical solutions and more efficient manufacturing with micro reactors, where DSM is unique in its pilot to commercial scale up offering.”

Dr. Tom Moody, Head of Almac Biocatalysis, stated “This collaboration has come at the right time as more and more customers need scalable green technologies to access difficult-to-make chiral chemicals. Having access to the right enzymes today will drive ‘hit to process’.” The introduction of enzymes into processes earlier in the drug discovery pipeline will therefore help to drive cost down as the projects move forward”. Dr. Stephen Barr, Managing Director of Almac’s Sciences business unit, added, “The synergies between Almac and DSM are not superseded today by any other collaboration in this area. Our customers will see real rewards from the fact that any bioprocess developed can go from conception to manufacture quickly within this agreement.”

Daniel Mink PhD, Corporate Scientist Biocatalysis and (Bio)-Organic Chemistry at DSM comments:

“One important success factor for implementing enzymatic routes is access to a diverse range of biocatalysts. DSM is continuously expanding its unique enzyme collection of more than 3,000 enzymes through in-house development as well as innovative partnering models. The collaboration with Almac completes the latest phase in this process. Together we will be able to offer a complete package serving the pharmaceutical industry at all stages of development from preclinical to commercial scale — bringing biocatalysis to the next level.”

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

About DSM – Bright Science. Brighter Living.™

Koninklijke DSM NV is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of about € 9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsmpharmaceuticalproducts.com and www.dsm.com.

The post Almac and DSM Sign Collaboration Agreement in Biocatalysis appeared first on Almac.

Almac Launches New Histone Reagents Catalogue and Custom Synthesis Service

admin — Mon, 17 Sep 2012 08:27:59 +0000

Almac has today announced the launch of a new reagent offering based on the provision of homogeneous full length histones with defined patterns of modification. The histone reagents will prove a highly valuable tool for researchers seeking to prosecute key drug targets in the field of epigenetics.

Almac’s unique array of platform technologies for the chemical synthesis of proteins, enable the provision of pure full-length natural histones containing a wide variety of post-translational modifications at any specified site(s) within the protein. The reagents are set to be offered through a catalogue of modified histones and additionally as a custom synthesis service to meet bespoke customer demands. Almac believes this will provide the epigenetic research community with a unique source of enabling research tools. The modified histone reagent provision complements Almac’s growing range of FLEXYTE® FLT assays for epigenetic targets.

‘This is a first class example of how Almac can harness its unique protein synthesis capability to provide a much needed source of tools to the epigenetic research field. I am delighted that we are able to offer such capabilities.’ commented Dr Charles Shields, Vice President of Peptide and Protein Technologies at Almac.

Notes to Editors

About Almac

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Launches New Histone Reagents Catalogue and Custom Synthesis Service appeared first on Almac.

Almac and VTU Technology form collaboration to provide customers with high yielding, fast-track generation of site-specific modified products

admin — Mon, 11 Jun 2012 08:16:44 +0000

Approach enables homogenous labelled product with retained biological activity

Almac and VTU Technology announced today their collaboration to offer joint services for the expression of recombinant proteins with site-specific modification and labelling, such as PEGylation for half-life extension of proteins.

Almac has previously developed technology for site-specific C-terminal modification of recombinant proteins. The technology can be applied to the generation of PEGylated proteins for half life extension, labelled proteins for PET and SPECT imaging, engineered and bispecific proteins and protein drug conjugates. Currently available protein labelling technologies produce products which are labelled at multiple sites in an uncontrolled manner. This inevitably results in a heterogeneous population of labelled molecules resulting in a net decrease in potency compared to the unlabelled analogue. The Almac approach allows the specific labelling site to be selected and controlled and generates a homogeneous labelled product in good yield with retained biological activity.

VTU Technology, a leading supplier of exclusive technologies and comprehensive services for the development of high yielding, high-performance Pichia pastoris protein expression strains and processes and Almac have recently completed a case study to prove the applicability of Almac’s site-specific PEGylation technology to proteins (single domain antibodies) produced through secreted expression from Pichia pastoris. The study clearly demonstrates the advantageous combination of a powerful eukaryotic expression system with a versatile approach for site-specific C-terminal protein modification and is applicable to a wide variety of modifications including attachment of polymers such as PEG, small molecule labels and synthetic peptides.

“We are delighted that our Pichia pastoris platform enables the production of intein-fusion proteins at high yields and proved to be perfectly compatible with Almac’s site-specific protein modification technology”, said Dr. Thomas Purkarthofer, Head of Business Development at VTU Technology.

“This collaboration between VTU Technology and Almac will help to further demonstrate the broad applicability of our Pichia protein production platform”, Purkarthofer added.

The Almac-VTU Technology alliance provides several benefits to biopharmaceutical companies seeking fast-track protein expression and process development and subsequent site-specific protein modification. This integrated service platform combines two proven and unique technologies. VTU Technology’s high-expression Pichia technology and speed in expression strain and process development along with Almac’s expertise in peptide and protein engineering techniques for the improvement of drug products. This ‘One-Stop-Shop’ offers customers an integrated approach with a smooth technology transfer throughout all phases.

“This exciting collaboration with VTU Technology has enabled us to demonstrate the utility of our unique protein engineering technology in Pichia therefore making our site-specific protein labelling solutions more accessible to the biotechnology community” commented Dr Stephen Barr, President and MD of Almac’s Sciences Business Unit.

VTU Technology and Almac will be exhibiting at the BIO 2012 International Convention in Boston and will be available to provide more information on intein-fusion protein expression and site-specific protein modification at booth 3265 and booth 1422 respectively.

Notes to Editors

About Almac:

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered inCraigavon,Northern Ireland.US operations are based inPennsylvania,North Carolina andCalifornia.

About VTU Technology:

VTU Technology is a leading contract research and development company, providing services for the fast track generation of high performance, industrial protein production strains and economically viable protein production processes for pharmaceutical companies and other protein manufacturers.

VTU’s exclusive Pichia pastoris expression platform is based on its 1^st and 2^ndgeneration AOX1 promoter libraries enabling proper fine-tuning of protein expression. Applied by VTU’s sophisticated team, this cutting-edge platform facilitates the delivery of unparalleled expression levels often achieving more than 10 g/L secreted protein (20 g/L peak expression level) within a few weeks development time for a wide range of proteins including serum proteins, cytokines, fusion proteins, Fabs, antibody derived fragments, scaffold proteins and enzymes.

VTU Technology is part of VTU Group, a provider of comprehensive technology services with over 200 employees and several sites and offices acrossEurope.

For more information about VTU Technology, please visit www.vtu-technology.com or e-mail office.technology@vtu.com.

The post Almac and VTU Technology form collaboration to provide customers with high yielding, fast-track generation of site-specific modified products appeared first on Almac.

selectAZyme™ grows into metabolite synthesis

admin — Mon, 13 Feb 2012 09:10:24 +0000

The biocatalyst group at Almac has doubled in size in the last year and is reaping rewards with major business growth in chiral building block supply, evolution and commercial manufacture projects as well as metabolite synthesis.

“Biocatalysis is now Almac’s first choice for any scale-up chemistry involving chirality resulting in cheaper, cleaner and robust processes” says Head of Biocatalysis, Dr. Tom Moody.

Metabolite synthesis is another tool within the selectAZyme^TM service offering that Almac has developed significantly in recent years, providing access to both oxidative and glycosylated products. Recombinant and microbial P₄₅₀ and glycosylating technology have been developed for accessing metabolites at mg to 100s grams scale. These enzymes mimic human systems and are a powerful tool for accessing metabolites rapidly and efficiently, typically in one step from the parent API.

Almac’s biocatalyst technology platform is well represented by the green selectAZyme^TM logo emphasising the “green” credentials the technology offers, from medicinal chemistry scaffold and metabolite synthesis through to commercial manufacture.

The application of biocatalysis results in reduced energy costs, lowered impact on the environment and efficient multi-tonne processing in timelines comparable to traditional chemistry.

Future plans involve discovery and development of novel P₄₅₀ and transaminase enzymes using metagenomic techniques which will significantly enhance and differentiate the portfolio of enzymes currently available to Almac and its customers.

If your process requires “greening” up, contact Almac’s biocatalysis group.

Almac will be exhibiting at the forthcoming Informex trade show, 14 – 17 February at Booth 2001.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post selectAZyme™ grows into metabolite synthesis appeared first on Almac.

Almac Celebrates MHRA Audit Successes

admin — Mon, 23 Jan 2012 09:21:21 +0000

Almac’s Sciences Business Unit has achieved dual success in MHRA inspections at both their Craigavon Headquarters, Northern Ireland and Elvingston, Scotland sites. Both inspections were the first biennial audits to confirm continued compliance with Investigation Medicinal Products (IMP) licenses and GMP certificates.

The first inspection audited Almac’s isotope chemistry facility in support of their IMP license. During the inspection, tours of the new manufacturing finishing suite and associated infrastructure, in support of the extended API facility were conducted.

Following the MHRA’s acceptance of Almac’s response report, Almac’s licence will be applicable to both radiolabelled and non-labelled IMPs.

The second inspection covered Almac’s analytical laboratory in Elvingston, Scotland, supporting its GMP certificate as a contract analytical facility. The Inspector complimented Almac’s analytical team on their professionalism and laboratory high standards. As a result of this successful audit, two GMP certificates will be issued for human and veterinary applications.

Commenting on this dual success, President and Managing Director, Stephen Barr said:

“We are delighted with the outcome of these inspections. It is reassuring to know that the value we place on our staff and facilities is recognised in this way, and adds further credibility to our wealth of experience and services we offer.”

Alan Chambers, Head of Quality added,

“This success is just reward for the hard work and professionalism of the radiolabelling and analytical teams at both of our sites. We can all take pride in the success of these audits and their positive affirmation of the quality system to which all staff at Almac contribute.”

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

The post Almac Celebrates MHRA Audit Successes appeared first on Almac.

MGB Biopharma and Almac Collaborate on Contract Manufacturing Project

admin — Tue, 17 Jan 2012 09:45:29 +0000

MGB Biopharma and Almac’s Sciences Business Unit have entered into a collaboration where Almac will manufacture the production of their lead gram positive antibacterial compound MGB-BP3.

The compound is a DNA minor groove binder and is currently in pre-clinical development with IND filing targeted for Q3 2012. CEO Dr Miroslav Ravic said “We were very quickly impressed with the approach taken by Almac and they have already shown an intuitive understanding of what it takes to support a small company like ours. We look forward to a continued successful relationship”.

Rick Dyer, VP Operations, Almac further commented “Almac has a wealth of expertise in early phase clinical development and we are delighted to undertake this phase of work for MGB Biopharma and hope this is the first of many successful projects between our companies.”

Following on from their expertise in early phase and steady growth in late phase clinical development, Almac recently announced a capacity expansion within its API facility, further leveraging its API and Drug Product integrated offering. This expansion will allow Almac to continue its commitment to deliver high quality API at competitive prices to its customers.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors

The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

The post MGB Biopharma and Almac Collaborate on Contract Manufacturing Project appeared first on Almac.

Almac’s rapidd continuing to accelerate early stage development 2 years on

admin — Tue, 25 Oct 2011 08:54:14 +0000

October 2009 saw Almac launch an integrated early development service, rapidd^TM, to address the issues of time, cost and attrition in early clinical candidate development by taking a lead drug development candidate to Phase I regulatory submission in under 12 months. Two years on, Almac are pleased to report strong demand for the early stage development package.

rapidd^TM works by offering a lean, flexible package, fully compliant with ICH guidelines, and integrated services between Almac and selected global CROs which is managed by Almac through a dedicated programme management team.

In 2011 alone, three integrated programmes have been completed with a further 5 ongoing, or in late planning stages. Over the past two years, interest has remained strong in both the NCE and biopharmaceutical markets from a range of clients from virtual biotech companies to large pharma with both small molecule and peptide candidates.

“rapidd^TMenables our clients to make significant savings against conventional lead times from careful programme optimisation and avoidance of tech transfer time and other common issues which arise in a multiple partner process”, commented Denis Geffroy, VP Business Development. “We are delighted that our rapidd^TMprogramme has proven so successful in helping to eliminate these barriers. With our range of single-site services and capabilities, we are confident that our package brings even more added value in our clients’ pre-clinical development programmes.”

In the current uncertain financial climate, Almac’s clients have benefited from the flexible approach rapidd^TM offers – from taking advantage of Almac’s pre-clinical expertise to enabling payment schedules to be structured in line with agreed investor milestone payments.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

The post Almac’s rapidd continuing to accelerate early stage development 2 years on appeared first on Almac.

Almac Invests in New Commercial API Manufacturing

admin — Mon, 24 Oct 2011 08:35:41 +0000

In order to satisfy increasing demands, Almac are expanding their manufacturing capacity to over 30m³ at its European Headquarters in Craigavon, UK. The upgraded facility will include reactor vessels with state of the art clean room product isolation and drying equipment to allow Highly Potent API manufacture up to 600kg batch size.

With currently 6 API and advanced chiral intermediates in Phase III clinical development, Almac has steadily increased its market penetration in late phase clinical development, leveraging its API and Drug Product Integrated offering. This major expansion will allow Almac to continue its commitment to deliver high quality API at competitive prices to its customers. Denis Geffroy, VP Business Development stated: “We are delighted with the progress made over the past 2 years to increase our presence in late phase clinical development. This capacity increase will allow a smooth transition from late phase clinical development to full commercialisation. Scale was becoming a limiting factor for some of our client projects and this new capacity is a strong commitment to offer project continuity. It opens up a new chapter in Almac’s API manufacturing capability”

It is anticipated that the facility will be built, commissioned and validated within the next 2 years. In the meantime, Almac will continue progressing late stage manufacturing projects within their existing facilities and with a number of key supplier relationships. Dr Rick Dyer, VP Operations added, ““This expansion allows us to build on our expertise in early phase clinical development projects and further continue our success within late phase projects so clients need not transfer some of our well developed processes elsewhere due to lack of scale. This investment will further place Almac as the supplier of choice to satisfy all client requirements from preclinical phase to full commercialisation.”

Almac’s advantage of hosting all facilities on one site have led to the successful technology transfer of small molecule and peptide projects from lab development to large scale manufacture.

Additionally, the increase in chiral late stage projects is attributed to Almac’s selectAZyme^TMtechnology platform. Almac is applying their enzyme technology to customer processes resulting in shorter and more stream lined syntheses. The customer sees immediate benefits due to lower chemical and manufacturing costs as well as applying green credentials to their process which is in line with the need to minimise environmental factors. Initially launched in 2009 with the sale of six enzyme kits, Almac’s biocatalysis capabilities have expanded to the supply of 100s of kgs of both chiral intermediates and APIs. Dr Tom Moody, Head of Biocatalysis notes “Biocatalysis is now recognised as a premier solution for solving complex chemistry problems due to its rapid implementation, economic benefits and “green” reputation. It is the technology of choice for chiral chemistry within Almac.”

Using selectAZyme^TM technology as opposed to conventional routes to APIs has significantly improved yields, productivity and timelines for multi-step syntheses. Denis Geffroy further commented, “We believe that our biocatalysis offering is unique within the marketplace and when coupled with our skills and expertise in synthetic chemistry, it opens immediate benefits to our customer projects. Our growth in this area, coupled with our planned facility expansion will give our clients maximum opportunity for success in their product development projects.”

For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 41C18) and AAPS (Booth 2837) conferences.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

The post Almac Invests in New Commercial API Manufacturing appeared first on Almac.

Almac Introduces selectAZymeTM

admin — Wed, 04 May 2011 08:56:32 +0000

Almac’s biocatalysis business continues its strong growth and boosts its visability with the launch of the selectAZyme^TM brand.

As anticipated, Almac’s biocatalysis business has expanded from its 2009 launch with the sale of six enzyme screening kits, to the current supply of 100s of kgs of chiral intermediates for drug substance manufacture, regular enzyme supply to specialty chemical companies and continued growth of its screening kits offering. Biocatalysis is increasingly recognised as an alternative solution for solving complex chemistry problems due to its rapid implementation, economic benefits and ‘green‘, reputation. Almac’s growth in this area was further enhanced last year through a $4 million R&D investment. The natural next step for the business is the launch of the selectAZyme^TM brand to enhance its recognition.

“The selectAZyme^TM brand conveys Almac’s strong biocatalysis offering. Almac is providing a diverse, A-Z range of enzymes including reductases, transaminases, hydrolases, nitrilases and many others. In collaboration with our customers, Almac selects the optimum enzyme to provide an efficient and cost effective process. Almac enzymes are used in the A-Z of applications from medicinal chemistry to full production and in the manufacture of specialty chemicals. The key strength of enzymes is the high selectivity of the chemical reactions they catalyze”, comments Dr. Tom Moody, Head of Biocatalysis.

The rapid scale-up from biocatalyst screening to production prompted the recent paradigm shift to bioprocessing acceptance for the synthesis of APIs and fine chemicals. Biocatalysis is Almac’s first choice for any scale-up of chiral chemistry due to the cost, efficiency, robustness and ‘green’ benefits that result.

Metabolite synthesis is another tool within selectAZyme’s service offering providing access to both oxidative and glycosylated products. Almac has implemented state-of-the-art biocatalytic technology for rapid metabolite synthesis, isolation and structural identification. Almac has developed recombinant P450 technology for accessing metabolites at mg to 100s grams. These enzymes, which mimic human P450 systems, are a powerful tool for accessing metabolites rapidly. Moody further elaborates, “The marriage of microbial and recombinant enzymes is a real powerhouse in accessing difficult to synthesise metabolites. The scale-up capability allows Almac to rapidly take “hits” from conception to gram delivery as and when the customer requires the products.” In addition, Almac can also supply radiolabelled versions of these metabolites utilizing their in-house Isotope Chemistry group.

Almac also offers technology consultancy, aiding and supporting clients to set-up and run enzyme screening and scale-up in their own labs. Almac does not impose any IP roadblocks to implementing the technology and provides a simple and direct path for customers to access the benefits of biocatalysis. Recently Dr. David Rozzell, a world renowned authority in biocatalysis, has signed-on as Scientific Advisor to help Almac advance the technology.

The selectAZyme^TM service complements Almac’s speciality capabilities, including radiolabelling, polymorph and solid form optimisation, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Discovery Services, including API and Drug Product Development and GMP Manufacture.

For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 861 3938 or e-mail: t.jervis@defacto.com.

Notes to Editors:

About Almac Group

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post Almac Introduces selectAZymeTM appeared first on Almac.

BioFocus and Almac collaborate to offer fluorescent lifetime assays

admin — Mon, 28 Mar 2011 11:49:44 +0000

BioFocus and Almac have initiated a collaboration which will provide BioFocus customers with compound screening and profiling services using Almac’s FLEXYTETM fluorescence lifetime (FLT) assays. FLT as a reading modality offers a robust, antibody free, homogeneous assay platform which enables the user to avoid interference from fluorescent compounds within a screening library.

BioFocus has launched an FLT screening and profiling service utilising the FLEXYTETM assay platform and now offer campaigns against targets including proteases, phosphatases and kinases. The unique properties of FLT have also been harnessed to open up access to previously inaccessible epigenetics target classes. Several approaches can be taken using the FLEXYTETM platform including fragment based screens and kinetic profiling.

‘Being able to incorporate FLT in our service offering enables BioFocus to provide clients an approach to screening and profiling that will unlock significant potential within their drug discovery efforts’ commented Dr Kate Hilyard, VP Biological Sciences, BioFocus.

‘We are delighted that BioFocus has chosen to add our FLEXYTETM platform to their service offering. We feel that this will allow a broad range of drug discovery groups access to the power of FLT’ said Dr Stephen Barr, President and Managing Director of Almac Sciences.

For media enquiries please contact:

Tristan Jervis , Associate Director

DeFacto Communications

T.Jervis@Defacto.com

Tel: + 44 2078 613019

Robert Grundy, PhD

Director Research Alliance, Almac Discovery Ltd

Robert.grundy@almacgroup.com

T: +44 (0) 28 3833 2200

About BioFocus

BioFocus aims to expand its partners’ drug pipelines by accelerating the gene-to-drug candidate discovery process. This is achieved through a comprehensive discovery platform, which includes target discovery in human primary cells, focused as well as diverse compound libraries, in vitro and cell-based screening, structural biology, medicinal chemistry, ADME/PK services, supported by unique chemogenomic and informatics tools, and compound library acquisition, storage and distribution services. As a service division of Galapagos, BioFocus has over 250 employees in four countries worldwide. More information at www.biofocus.com

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new $120m North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post BioFocus and Almac collaborate to offer fluorescent lifetime assays appeared first on Almac.

Almac discusses its investment in biocatalysis lauding cost and environmental benefits on OutsourcingPharma.com

admin — Tue, 23 Nov 2010 14:16:15 +0000

Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.

Click here to listen to the podcast featuring Tom Moody, head of Almac’s biocatlaysis unit (Almac Sciences business unit).

About Almac

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall.

For more information on Almac, please visit almacgroup.com or email info@almacgroup.com

The post Almac discusses its investment in biocatalysis lauding cost and environmental benefits on OutsourcingPharma.com appeared first on Almac.

Almac continues biocatalysis business growth with a further $4m R&D investment

admin — Thu, 07 Oct 2010 14:44:52 +0000

The need for green, economic, robust and scaleable processes for the synthesis of chiral APIs and intermediates prompted Almac (CPHI Booth 4F32) to build and fully integrate a biocatalysis group into its service portfolio. Last year Almac launched carbonyl reductase, transaminase, hydrolase, nitrilase, and nitrile hydratase enzyme screening kits and is continuing to both advance the biocatalysis business – and to broaden application of its biocatalysis expertise with a further $4m R&D investment.

The investment will be used primarily to focus around discovery of new biocatalytic platforms that can be rapidly implemented and scaled delivering cost effective processes to chiral intermediates. Other areas of research will investigate hyper-activation of biocatalysts reducing enzyme loadings, as well as development of efficient and robust drivers for cofactor recycle and problems with equilibriums.

As anticipated, the business has advanced from the sale of enzyme screening kits, then to screening and optimising custom transformations, and finally to the supply of 10s then 100s of kgs of chiral intermediates.

For example, preliminary screening was carried out to demonstrate that a carbonyl reductase (CRED) bioreduction could replace a resolution for the preparation of a chiral alcohol. Having identified a CRED at small scale, Almac prepared a hundred grams of the chiral alcohol and integrated it into the API process development programme.

The next step was to manufacture 30 kgs for incorporation into the GMP API manufacture for Phase I clinical trials.

The rapid scale-up from biocatalyst screening has been the critical success factor for the recent paradigm shift to bioprocessing acceptance for the synthesis of APIs and fine chemicals.

“The biocatalyst is now Almac’s first choice for scale-up chemistry involving chirality as it provides efficient, clean and robust processes. The $4m R&D investment demonstrates Almac’s continued commitment to biocatalysis, supporting further growth in our expertise and capabilities in biotechnology” notes Head of Biocatalysis Dr. Tom Moody.

“Clean-up” application:

The latest addition to the application of Almac biocatalysis expertise is for the “clean-up” of chemical reactions (Moody, T. Pharma Chem, April/May edition, 36-38, 2010). Impurities produced in multi-step processes are often difficult to remove, particularly if they are similar in structure to the desired product. When crystallisation or partition does not provide sufficient purity, Almac has used a biocatalytic process to selectively modify impurities. The impurities are then sufficiently different in physical properties from the desired product that they can be removed using conventional separation techniques.

“Biocatalysis provides a mild, regio & chemoselective process to modify impurities, thus altering their physical properties to facilitate their removal” says Tom Moody.

ENDS

Contact:

Tom Moody

Head of Biocatalysis

Almac

T: +44 (0) 28 3833 2200

F: +44 (0) 28 3833 2299

Tristan Jervis

Account Director

De Facto Communications

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

Notes to Editors

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,800 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters, which started in July 2008, and employees will relocate during the fall.

For more information on Almac, please visit almacgroup.com

The post Almac continues biocatalysis business growth with a further $4m R&D investment appeared first on Almac.

Almac extends Site-specific PEGylation Technology to single domain antibodies

admin — Thu, 29 Apr 2010 16:10:47 +0000

Almac will be attending the annual Bio Industry Association convention BIO 2010 where they will announce the extension of their unique site specific PEGylation technology to cover single domain antibody fragments.

In exemplifying the site specific PEGylation technology with single domain antibodies and interferons Almac have demonstrated that therapeutically important complex biological proteins can be engineered to offer viable candidates for development as therapeutic agents.

Currently available PEGylation technologies produce products which are PEGylated at multiple sites in an uncontrolled manner. This inevitably results in a heterogeneous population of PEGylated molecules resulting in a net decrease in potency compared to the un-PEGylated analogue. The Almac approach allows the specific PEGylation site to be selected and controlled and generates a homogeneous PEGylated product. The result is improved efficacy compared to existing PEGylation techniques leading to lower dose levels and consequently lower cost of goods; while still providing improved ADME profile due to the addition of the PEG moiety.

Commenting on the development of Almac’s site specific ligation technology Almac Sciences’ President and Managing Director, Stephen Barr said ‘ The application of our unique ligation technology to the PEGylation of single domain antibody fragments further demonstrates the benefit of Almac’s state of the art peptide and protein engineering techniques for the improvement of drug products.’

Almac will be exhibiting at the BIO meeting in Chicago and will be available to provide more information on site specific PEGylation at booth 5205.

-END-

For further information contact:

Robert Grundy

Director Research Alliances

T: +44 (0) 28 3839 5794

E: robert.grundy@almacgroup.com

T +44 (0)28 3833 2200

Tristan Jervis

Account Director

De Facto Communications

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

About Almac Group:

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS & ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 2008 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac extends Site-specific PEGylation Technology to single domain antibodies appeared first on Almac.

New FLEXYTE® Protease Assays Enable Information-rich Output, Miniaturization and Multiplexing

admin — Wed, 07 Apr 2010 16:15:37 +0000

Almac launches FLEXYTE® protease assay platform – the next step in exploration of fluorescent lifetime technology – at the 2010 Society for Biomolecular Sciences (SBS) meeting in Phoenix (11-15 April).

The new FLEXYTE® protease assays follow on from the great success of FLEXYTE® protein kinase assays launched in 2009. FLEXYTE® protease assays harness the power and potential of fluorescence lifetime technology for robust, efficient and economical screening of proteases. Avoiding radioactivity, antibodies and associated costs, fluorescence lifetime technology enables homogenous, robust and reliable assays with minimized interference from problem compounds, and will allow miniaturization, and multiplexing, while maintaining an information-rich output.

FLEXYTE® protease assays are based on labelled peptide substrates which have been developed for a variety of proteases. The generic peptide approach enables FLEXYTE® protease assays to be configured for a broad range of proteases. Almac will provide a custom assay development service for any protease of interest to customers.

Commenting on the launch of FLEXYTE® protease assays, Almac Sciences’ President and Managing Director, Stephen Barr said: “FLEXYTE® protease assays represent the next step in utilization of fluorescent lifetime technology to produce more robust, reliable and efficient assays in therapeutically important target classes.”

Almac will be exhibiting at the SBS meeting and will be available to provide more information on FLEXYTE® protease and protein kinase assays at booth 229.

-ENDS-

Contact:

Robert Grundy

Director Research Alliances

Almac Group Ltd.

T: +44 (0) 28 3839 5794

E: info@flexyte-assays.com

W: www.flexyte-assays.com

Tristan Jervis

Account Director

De Facto Communications

330 High Holborn

London WC1V 7QD

T: +44 (0)207 861 3838

E: t.jervis@defacto.com

Notes for Editors:

• FLEXYTE® dedicated technical presentations and supporting data are available on request to info@FLEXYTE-assays.com.

• To find out more about FLEXYTE®, visit www.flexyte-assays.com

About FLEXYTE®

FLEXYTE® harnesses the power and potential of fluorescence lifetime technology for robust, efficient and economical screening of protease kinases and proteases.

Avoiding radioactivity, antibodies and associated costs, fluorescence lifetime technology enables homogenous, robust and reliable assays with minimized interference from problem compounds, and will allow miniaturization, and multiplexing, while maintaining an information-rich output.

Generic substrates enable fluorescent lifetime assays to be configured for a broad panel of Ser/Thr protein kinases in a rapid fashion, covering over 100 different kinases – and with performance comparable to radiometric assays. The FLEXYTE® approach is applicable to any protein kinase having the appropriate peptide substrates. Assay reagents and protocols will be available in bulk form for high throughput screening or in kit form for lower capacity assays.

About Almac Group:

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post New FLEXYTE® Protease Assays Enable Information-rich Output, Miniaturization and Multiplexing appeared first on Almac.

Almac Expands Radiolabelling Facilities to Include 14C API and IMP Supply

admin — Fri, 26 Feb 2010 17:18:33 +0000

Launch of new MHRA audited facility will enable Almac to meet the rapid timelines required by Pharma companies in drug development.

Almac, an integrated contract development and manufacturing organisation supporting the international pharmaceutical and biotechnology industries, has further enhanced its radiolabelling capabilities with a significant facility expansion.

The opening of the facility follows Almac’s official accreditation for cGMP manufacturing and the securing an Investigational Medicinal Products (IMP) drug product-manufacturing license, from the Medicines and Healthcare Regulatory Agency (MHRA) in May 2009.

The new laboratories are the culmination of nearly 5-years work by the Almac Group, since originally receiving a Carbon-14 license in 2005, and will be opened by Dr Ken Lawrie of GlaxoSmithKline, and Chairman of the International Isotopes Society (UK Group), on 26 February 2010.

The expanded laboratories will include some 20 new workstations, 14 synthesis and a further 6 ‘general’ workstations for chemistry and analysis. These facilities will be staffed by a 20 strong team of dedicated radiochemists, including Dr Sean Kitson who received the 2006 Wiley Journal of Labelled Compounds and Radiopharmaceuticals Young Scientists award for his work on the elaborate radiosynthesis of the Parkinson’s drug (R)-(-)-[6a-14C]apomorphine.

In addition, the expanded facilities will also feature a new, dedicated manufacturing finishing suite for the development of IMPs used in clinical trials, and the final steps in Active Pharmaceutical Ingredients (API) manufacture. This will allow analytical chemists to carry out critical testing of a labelled IMP and undergo x-ray powder diffraction (XRPD) to determine the degree of polymorphism, all on the same site.

Commenting on the announcement, Almac’s VP, Operations Dr Rick Dyer, said: “Almac has started the New Year with a firm resolution to provide a clear pathway for pharma companies to meet the radiolabelling requirements in Phase 1 to Phase 3 clinical trials, signalling our intent to work very closely with the high quality servicing needs of the sector. Our capability to provide cGMP for final drug candidates, peptides, small molecules and advanced intermediates responds competitively to the demands of the market. Almac also now offers QP release.”

-ENDS-

For further information contact: Tristan Jervis Account Director De Facto Communications 330 High Holborn London WC1V 7QD T: +44 (0)207 861 3838 E: t.jervis@defacto.com

About Almac Group: Almac is a financially stable, privately owned organisation with over 30 years experience. It provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation and analytical development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture and packaging.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post Almac Expands Radiolabelling Facilities to Include 14C API and IMP Supply appeared first on Almac.

Almac Announces that AstraZeneca is to Undertake Evaluation FLEXYTE Protein Kinase Assays

admin — Mon, 18 Jan 2010 17:32:55 +0000

Almac Group Ltd and Edinburgh Instruments Ltd announce that AstraZeneca is to carry out an evaluation of the newly launched FLEXYTE™ protein kinase assay platform.

During the evaluation period AstraZeneca will assess the performance of the FLEXYTE™ platform in its laboratories against specific targets of interest.

‘We are delighted that AstraZeneca have shown this level of interest in our proprietal protein kinase assay platform. Their evaluation of FLEXYTE™ indicates the potential of fluorescence lifetime as a reporting modality for kinase assays’ said Stephen Barr Almac Sciences’ President and Managing Director.

FLEXYTE™ assays harness the potential of fluorescence lifetime and applies it to the process of assaying kinase activity and marks a successful collaboration between Almac Sciences, Edinburgh Instruments and DundeeUniversity.

Avoiding radioactivity, antibodies and associated costs, fluorescent lifetime technology enables homogenous, robust and reliable assays with minimized interference from problem compounds, and will allow miniaturization, and multiplexing, while maintaining an information-rich output.

FLEXYTE™ assay reagents and protocols are available in bulk form, for high throughput screening, or kit form, for lower capacity assays.

-ENDS-

For further information contact:

Robert Grundy

Director Research Alliances Almac Group Ltd. T: +44 (0) 28 3839 5794 E: info@flexyte-assays.com W: www.flexyte-assays.com

Tristan Jervis Account Director De Facto Communications 330 High Holborn London WC1V 7QD T: +44 (0)207 861 3838 E: t.jervis@defacto.com Notes for Editors:

• FLEXYTE™ dedicated technical presentations and supporting data are available on request to info@FLEXYTE-assays.com. • To find out more about FLEXYTE™, visit www.flexyte-assays.com

AboutFLEXYTE™ FLEXYTE™ harnesses the power and potential of fluorescence lifetime technology for robust, efficient and economical screening of protein kinases.

FLEXYTE™ assays have already been developed for 11 different representative protein kinases. Protease assays will follow in the near future, with lipid kinases also in development. The protein kinase programme marks a successful collaboration between Almac Sciences, Edinburgh Instruments and DundeeUniversity.

Generic substrates enable fluorescent lifetime assays to be configured for a broad panel of

Ser/Thr protein kinases in a rapid fashion, covering over 100 different kinases – and with performance comparable to radiometric assays. The FLEXYTE™ approach is applicable to any protein kinase having the appropriate peptide substrates. Assay reagents and protocols will be available in bulk form for high throughput screening or in kit form for lower capacity assays.

About Almac Group: Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters in PA started in July 2008 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

About Edinburgh Instruments: Since its establishment in 1971, Edinburgh Instruments Ltd has become recognised as a leading light in the photonics and electro-optics industries. It is now located in purpose built facilities just outside Edinburgh, where it employs around 60 people.

Over the years Edinburgh Instruments has continually sought to diversify and develop new and innovative products, winning many international design, technology and export achievement awards.

The company has pioneered developments in time resolved fluorescence for over 30 years with some 600 research spectrometers used world-wide in industries as diverse as medical, bio-physical, plasma and semiconductor research, chemical analysis, forensic science, to cutting and marking in industrial applications.

For more information about Edinburgh Instruments please visit www.edinst.com or e-mail sales@edinst.com.

The post Almac Announces that AstraZeneca is to Undertake Evaluation FLEXYTE Protein Kinase Assays appeared first on Almac.

Almac Launches Unique Site-specific PEGylation Technology at BIO Europe

admin — Mon, 02 Nov 2009 11:29:43 +0000

Almac’s site-specific Ligation technology takes advantage of impressive expertise in production and engineering of both recombinant proteins and synthetic peptides to develop a proprietary technology which overcomes issues inherent with other conjugation approaches.

The technology has been developed into an enabling and practical approach for site-specific PEGylation of recombinantly derived proteins.

Currently available PEGylation technologies produce products which are PEGylated at multiple sites in an uncontrolled manner. This inevitably results in a population of molecules PEGylated in locations which crowd the active center or binding regions resulting in a net decrease in potency versus the un-PEGylated analogue. The Almac unique approach enables homogeneous PEGylated populations where the specific PEGylation site can be selected and controlled, thus improving efficacy compared to existing PEGylation techniques, decreasing cost of goods and substance dosed to patient; while still providing improved ADME profile due to the addition of the PEG moiety.

In addition, for synthetic peptides and proteins, Almac has extensive expertise in the synthesis, engineering and labelling of polypeptides of up to 200 amino acids. Site specific PEGylation of synthetic folded polypeptides can be achieved using a generic methodology developed for the site-specific labelling of folded synthetic proteins in high yield.

Commenting on the launch of Almac’s site-specific Ligation technology, Almac Sciences’ President and Managing Director, Stephen Barr said ‘ The application of our unique ligation technology to the field of half life extension with site specific PEGylation will enable our partners to benefit from Almac’s state of the art peptide and protein engineering techniques for the improvement of their drug products.’

About Almac Group:

The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters in PA started in July 2008 and will be completed in 2010.

The post Almac Launches Unique Site-specific PEGylation Technology at BIO Europe appeared first on Almac.

“rapidd” Accelerating Early Stage Development, Minimising Cash Burn

admin — Wed, 14 Oct 2009 10:27:41 +0000

Almac report strong demand in rapidd™ – an early stage development package taking lead drug development candidates to Phase I regulatory submission in under 12 months. Setting a new standard for early stage development packages, rapidd™ was showcased for the first time at CPhI 2009 in Madrid. rapidd™ is being offered by Almac in conjunction with a number of market leading contract research organizations (CROs) – including Covance.

A complete set of solutions, rapidd™ – accelerated process integrated drug development – creates opportunities for added value in pre-clinical development, while offering significant savings.These include reduced cash burn, earlier milestones attainment and competitive advantage from an accelerated drug programme. rapidd™ clients will release management time for added value creation, with time saving-to-market speeding investment returns.

Rapidd™ is a flexible, integrated package offered on a single-contract and managed by a dedicated team under a single contact/project manager. Dramatic savings against conventional lead times come from programme optimisation and avoidance of tech transfer time and other multiple partner issues.

“Rapidd™ rewrites the standard for early stage development packages. The shorter timelines and reduced cash consumption have clear benefits for new product time and cost-to market”,

commented Almac Sciences’ President and Managing Director Director Stephen Barr.

“Almac’s range of integrated, single-site services and capabilities also brings potential for added value in pre-clinical development”,

he added.

Peter Sausen, Global Vice President of Integrated Drug Development at Covance, commented:

“In continually exploring ways to integrate and streamline drug development processes for global clients, we are delighted to be working with Almac on their rapidd™ programme.”

RapiddTM provides all aspects of early stage development including small molecule or peptide API manufacture, formulation development, non-clinical safety assessment, regulatory support and clinical trial supplies.

The rapidd™ service package enables flexible approaches to client requirements and integrated drug development to CTA, FIM or POC.

– ENDS –

For further information contact:

Denis Geffroy

VP Business Development – Almac Sciences

Tel: +44 (0)28 3833 2200

Fax: +44 (0)28 3833 2299

Denis.geffroy@almacgroup.com

About Almac Group:

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

The post “rapidd” Accelerating Early Stage Development, Minimising Cash Burn appeared first on Almac.

Almac and Edinburgh Instruments launch of FLEXYTE fluorescence lifetime assays at MipTec

admin — Tue, 13 Oct 2009 10:42:33 +0000

Almac, a leading provider of integrated research, development and manufacturing services to the pharmaceutical industry and Edinburgh Instruments, manufacturers of fluorescence spectrometers, have launched a fluorescence assay system under the FLEXYTE™ brand – harnessing the power and potential of fluorescence lifetime technology for robust, efficient and economical screening of protein kinases.

FLEXYTE™ will be launched at the MipTec meeting in Basle Switzerland on the 13th – 15th October 2009.

FLEXYTE™ assays have already been developed for 11 different representative protein kinases. Protease assays will follow in the near future, with lipid kinases also in development. The protein kinase programme marks a successful collaboration between Almac Sciences, Edinburgh Instruments and DundeeUniversity.

Generic substrates enable fluorescent lifetime assays to be configured for a broad panel of Ser/Thr protein kinases in a rapid fashion, covering over 100 different kinases – and with performance comparable to radiometric assays. Almac notes that the FLEXYTE™ screen approach is applicable to any protein kinase having the appropriate peptide substrates. Assay reagents and protocols will be available in bulk form for high throughput screening or in kit form for lower capacity assays.

Commenting on the FLEXYTE™ introduction, Almac Sciences’ President and Managing Director, Stephen Barr said:

“FLEXYTE™ will offer significant advantages to screening laboratories of all capacities by applying the benefits of fluorescence lifetime to a high performance kinase assay platform.”

For Edinburgh Instruments, Des Smith, CEO added “We are very excited to be able to offer a platform which applies the power of fluorescence lifetime technology to generic kinase screening through FLEXYTE™ assays.”

FLEXYTE™ integrates the strengths and experience of all three programme partners. Almac Sciences brings proven expertise in the synthesis of fluorescent labelled peptides and proteins, in the development of proprietary fluorophores for fluorescent lifetime applications and in biochemical assay development.

With a history of pioneering developments in time resolved fluorescence spectroscopy, Edinburgh Instruments is focused on the design and manufacture of fluorescence spectrometers, with a world base of more than 500 spectrometers in 45 countries. DundeeUniversity has proven expertise in the protein kinase field, in running screening services and in collaborating with industrial partners.

– ENDS –

For further information contact:

Robert Grundy

Director Research Alliances,

Almac Group Ltd.

+44 (0) 28 3839 5794

info@flexyte-assays.com

www.flexyte-assays.com

Notes for Editors:

FLEXYTE™ dedicated technical presentations and supporting data are available on request to info@FLEXYTE-assays.com.
To find out more about FLEXYTE™, visit www.flexyte-assays.com

About Almac Group:

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com.

About Edinburgh Instruments:

Since its establishment in 1971, Edinburgh Instruments Ltd has become recognised as a leading light in the photonics and electro-optics industries. It is now located in purpose built facilities just outside Edinburgh, where it employs around 60 people.

Over the years Edinburgh Instruments has continually sought to diversify and develop new and innovative products, winning many international design, technology and export achievement awards.

For more information about Edinburgh Instruments please visit www.edinst.com or e-mail sales@edinst.com.

The post Almac and Edinburgh Instruments launch of FLEXYTE fluorescence lifetime assays at MipTec appeared first on Almac.

MHRA Grants Almac IMP License for its Radiolabelling Service

admin — Tue, 21 Jul 2009 11:48:23 +0000

Almac has announced the extension of its radiolabelling services to include drug product – moving the company into the forefront of GMP radiolabelling.

Almac’s customers can access a full range of radiolabelling services for both large molecules (peptides and proteins) and small molecules.

The market is increasingly moving towards GMP requirements for 14C labelling for both API and drug product. Responding to this market demand, Almac has completed its service extension to now include radiolabelling of drug product and QP release. This new service received MHRA approval with an IMP license in May 2009.

The successful MHRA audit built on Almac’s long held reputation as a service provider meeting the highest standards of Quality Assurance.

QA Manager Alan Chambers commented:

“The IMP license award is a major milestone for our radiolabelling offering and now enables Almac to manufacture radiolabelled drug product for direct use in clinical studies. This achievement places Almac at the forefront of the global GMP radiolabelling industry”.

Responding to the news of the success, Almac Chairman and founder, Sir Allen McClay, said:

“I warmly congratulate the Quality Assurance team that were key to this achievement. Quality and Reliability are the standards that will take and maintain Almac at the forefront of our field”.

Almac also offers a fully integrated set of services, RAPIDDTM (Accelerated Process Integrated Drug Development) including API, formulation, analytical, pre-clinical safety assessment and regulatory documentation to complete lead candidate to entry into Phase I clinical trials in under 12 months.

Almac is a US $750m group with over 2,400 employees supplying over 600 companies worldwide – including all the global leaders in the pharma and biotech sectors.

END-

Contact

Denis Geffroy	Roger Johnstone
VP Business Development – Almac Sciences	Deben Editorial Services
Tel: +44 (0)28 3833 2200	Tel: +44 (0)161 614 1450
Mobile: +44 (0) 7834 498942	Mobile: +44 (0)7841 433141
Fax: +44 (0)28 3833 2299	Fax: +44 (0)161 614 1450
Denis.geffroy@almacgroup.com	rdj@debened.co.uk

Notes to the Editor:

About Almac Group:

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS and Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,400 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters started in July 2008 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.

For more information about the Almac Group, please visit almacgroup.com or e-mail info@almacgroup.com

The post MHRA Grants Almac IMP License for its Radiolabelling Service appeared first on Almac.

Almac Launches Biocatalyst Kits

admin — Thu, 23 Apr 2009 13:55:30 +0000

Almac Sciences has launched a range of biocatalysts in comprehensive, easy-to–use kits for customer evaluation. The kits cover hydrolases, carbonyl reductases, nitrilases and transaminases – with development and manufacturing quantities available on a transparent and straightforward GBP/Kg. basis.

Now established as the versatile “4×4” of the chirals tool box, biocatalysis is also increasingly recognised as offering economic and green solutions to complex pharma chemistry problems.

Almac biocatalysts provide access to a broad range of chiral acids, esters, alcohols and amines – and to libraries of enzymes for customer evaluation. (For detailed kit descriptors, see Notes for Editors)

Screening for customer-requested biotransformations, process optimisation and manufacture of chiral products by biocatalysis is also now available from Almac’s Biocatalysis Development Group. (Email: biocatalysis@almacgroup.com)

“Introduction of the new kits aims to deepen customer recognition of biocatalysis benefits”, notes Biocatalysis Team Leader Dr. Tom Moody. “The biocatalyst option is now Almac’s first choice for any scale-up chemistry involving chirality.

“Biocatalysis can provide mild, regio & chemo selective conditions that often cannot be matched by chemical derived routes and it offers economic, robust, scaleable and reliable processes.”

Almac also points to major bonuses from reduced energy costs, lowered impact on the environment and efficient multi-tonne processing in timelines comparable to traditional chemistry.

Biocatalysis has greatly expanded Almac’s technology offering. The Biocatalysis Development Group – including molecular and microbiologists, enzymologists, organic chemists and analysts – is closely linked to Almac’s process chemistry and pilot plant capabilities, with enzyme discovery and development integrated with screening, route definition and subsequent scale up. Rapid implementation of enzymatic steps has significantly improved yield and time-lines in production of complex chiral APIs and intermediates.

The biocatalysis move was previewed at Informex USA, with range introduction at this month’s CPhI Japan exhibition. The latest addition to Almac’s portfolio of connected capabilities, it follows the launch in late 2008 of Solid State Chemistry services.

Almac Science’s main service lines run through contract R&D, custom manufacturing and analytical services. The company has unique offerings in potent & cytotoxic manufacture, peptide and protein synthesis, cGMP and non-GMP radiolabelling (14C), chiral products and technology, solid state chemistry services, micronisation, formulation development and drug product manufacture.

Almac offers integrated services from research through development to delivery of finished pharma products. Services are provided to over 600 global companies – including all the market leaders in the pharma and biotech sectors.

-END-

Dr. Rosaleen McGuckin

VP Business Development – Almac Sciences

Tel: +44 (0)28 3839 5830

Mobile: +44 (0) 7803 830775

Fax: +44 (0)28 3833 2299

rosaleen.mcguckin@almacgroup.com

Roger Johnstone

Deben Editorial Services

Tel: +44 (0)161 614 1450

Mobile: +44 (0)7841 433141

Fax: +44 (0)161 614 1450

rdj@debened.co.uk

NOTES FOR EDITORS:

Biocatalyst kit availability:

- Carbonyl Reductase (CRED) biocatalysts

The kit contains 40 diverse CRED biocatalysts (40×50 mg), pre-prepared phosphate buffer (1×200 mL) ready for use, NAD (1×150 mg) and NADP (1×150 mg) cofactors, DMSO (1×5 mL), glucose dehydrogenase (GDH, 1×500 mg) and glucose (1×5 g) for the recycle system. Detailed user guide included.

- Hydrolase biocatalysts

Screening kits have been built for ease of use and contains 45 commercially available hydrolases (45×500 mg), pre-prepared phosphate buffer (2×200 mL) for hydrolysis and a selection of acyl donors for selective acylation of alcohols and amines (vinyl acetate (1×5 mL), vinyl butyrate (1×5 mL), succinic anhydride (1×5 g), ethyl acetate (1×5 mL) and ethyl butyrate (1×5 mL)). Detailed user guide included.

- Nitrilase and nitrile hydratase (NHase) biocatalysts

Screening kits consist of 9 NHases (9×50 mg) and 5 Nitrilases (5×50 mg), pre-prepared phosphate buffer (1×200 mL) for hydrolysis, DMSO (1×5 mL) and a user guide. R&D quantities and commercial supply of the biocatalysts are available upon request.

- Transaminase (TAm) biocatalysts

Almac is currently developing and evaluating a range of TAm enzymes for both in-house screening and for customer screening. The evaluation consists of R/S selectivity screening, solvent tolerance, reproducibility and methods to ensure high yield where limited by the equilibrium.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture.

The company has over 2,400 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters commenced in July 2008 and is expected to be completed in 2010. Almac was awarded the Belfast Telegraph ‘Business of the Year’ award in 2009.

To find out more about Almac visit almacgroup.com.

< Back to News Page

The post Almac Launches Biocatalyst Kits appeared first on Almac.

Almac Promotes Biocatalysis and Radiolabeling

admin — Thu, 29 Jan 2009 11:35:01 +0000

Almac Sciences is promoting its biocatalysis and Radiolabeling capabilities at Informex (Booth 728).

The development and application of biocatalysis has greatly expanded Almac’s technology offering. Enzyme discovery and development are integrated with screening and route definition for the synthesis of chiral acids, amides, esters, alcohols and amines. Almac now has the capability to create scaleable cloned biocatalysts for synthesis of these compounds.

“Combining this technology with powerful synthetic chemistry and gram-to-tonne manufacturing capability provides a very powerful boost to what we can offer to our customers”

says Biocatalysis Leader Dr. Tom Moody.

“Biocatalysis can provide mild, regio & chemo selective conditions that often cannot be matched by chemical derived routes. The biocatalyst option is the first choice for Almac for any scale-up chemistry involving chirality”,

Dr. Moody adds.

Almac is known for its expertise in custom synthesis at milligram, gram and multi-kilogram scale, through its high quality pilot plant and for technical transfer of processes to its customers. Integration of biocatalysis with this expertise, process development and manufacturing knowledge has allowed solutions to be found to some very challenging problems at large-scale.

Almac has also announced expansion of its GMP and non-GMP radiolabeling (14C) service. The company is one of the few API contract service players with this capability, offered as a standalone service, or to meet diverse needs within a multiphase project.

Business Development VP Dr. Rosaleen McGuckin says that the company’s specialist team is being expanded to meet rising customer demand since the service was first introduced two years ago. We plan to double our capacity in the next few months – and have seen particular recent interest in fermentation radiolabeling, which strongly complements our growing capabilities in biocatalysis”.

Almac can 14C label and formulate any compound – small molecules, peptides, potent, cytotoxic and fermentation products. 14C labeling services cover clinical and pre-clinical supplies; radiochemical stability studies; advice on label position; synthetic route design; storage and repurification and formulation of radiolabeled drug product.

Almac’s main service lines run through contract R&D, custom manufacturing and analytical services, with unique offerings in potent & cytotoxic manufacture, peptide and protein synthesis, cGMP and non-GMP radiolabeling (14C), chiral products and technology, solid state chemistry services, micronization, formulation development and drug product manufacture.

About Almac

The company has over 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters commenced in July 08 and is expected to be completed in 2010.

To find out more about Almac visit almacgroup.com

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin	Roger Johnstone
VP Business Development – Almac Sciences	Deben Editorial Services
Tel: +44 (0)28 3839 5830	Tel: +44 (0)161 614 1450
Mobile: +44 (0) 7803 830775	Mobile: +44 (0)7841 433141
Fax: +44 (0)28 3833 2299	Fax: +44 (0)161 614 1450
E: rosaleen.mcguckin@almacgroup.com	E:rdj@debened.co.uk

The post Almac Promotes Biocatalysis and Radiolabeling appeared first on Almac.

Almac Sciences: a global supply chain approach

admin — Wed, 05 Dec 2007 14:48:20 +0000

05 Dec 2007. With its distinctive “subway map” ad. and marketing campaign, the Almac Sciences network (Hall 16 Stand A75) has numerous stations and no shortage of connections.

Main lines run through contract R&D, custom manufacturing and analytical services. But the standout features are in niche areas and, increasingly, in what VP Commercial Operations Dr. David Moody sees as exceptionally wide ranging service “connectivity” – and the business model that delivers the offer.

Almac Sciences niche specialisms include the ability to deliver potents at 100+ kg scale, cytotoxics at 10s kg scale, chirals and biocatalysis, micronisation, custom synthesis of various peptide classes including peptide cytotoxic conjugates – and cGMP and non-GMP 14C labelling of NCEs from small molecule chirals to long peptides.

Three developments this year have already underlined the strength of Almac Sciences’ niche capabilities and its ability to partner with other key players in a global supply chain.

The first was its announced certification by Safebridge® in the safe handling of potent pharmaceutical compounds for its cytotoxic and potent compound manufacturing operations. Certification covers facilities, containment equipment, procedures and personnel training at the division’s Craigavon, Northern Ireland facility. Almac became the first CMO in Europe to achieve the coveted status.

Simultaneously, it announced collaboration for cytotoxic fill-and-finish services with the Coldstream Laboratories, Lexington, Kentucky – and a key chiral technology agreement with BioCatalytics Inc..

Total supply chain:

“We continue to meet our customers’ diverse and increasingly complex needs by combining Almac’s world class capabilities with complementary services of other leading industry players”,

says David Moody.

“That means a total supply chain approach to manufacturing, with high-flexibility from mgs. to tonnes, irrespective of complexity and regulatory status – and a very special approach to key customers and preferred supplier relationships”.

In the Almac Sciences model,

“global manufacturing”

means the best manufacturing solution, using appropriate large scale API assets – anywhere. As Business Development VP Dr. Rosaleen McGuckin says:

“Given our chemistry, technology and tech transfer skills, the key is often in project management at scale – and adding value within a deep technical relationship with each chosen manufacturing partner”.

Making it happen:

Almac Sciences’

“Supply Chain Solution”

model connects manufacturing chemistry, raw material management, tech transfer and supported manufacture to deliver

“quality on time in full”.

It calls for breadth in manufacturing capabilities, range of manufacturing scale(s), with cost effective asset options and commitment to HSE and to strong, enduring relationships – all combining to maximise speed and flexibility while controlling cost.

According to Dr. Moody:

“Making this happen in practice needs to connect the learning from previous campaigns; targeted process development; effective technical transfer and a collaborative approach to manufacture and project stewardship”.

In a recent example for a US customer, Almac Sciences faced significant raw material supply, quality and timescale challenges.

Applying its

“Supply Chain Solutions”

model it developed a custom raw material manufacturing process, with supply chain construction and management and a

“joint task force”

approach to technology transfer with the appointed manufacturer.

This drove specific gains in process development and improvement, delivering improved yields and operability. Crucially, it also achieved

“de-risked”

future raw material supply.

Once the project was running, Almac Sciences were present for the first run of each step, followed by daily (operational) and weekly (project team) teleconferences to share learning and gains.

Almac was able to supply the customer with QUOTIF against challenging timelines, while achieving all aspects of process economics.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Contact: Dr Rosaleen McGuckin

T: + 44 (0)28 3833 2200

E: sciences@almacgroup.com

W: almacgroup.com

The post Almac Sciences: a global supply chain approach appeared first on Almac.

Almac Sciences: “First in man” approach to peptides

admin — Wed, 05 Dec 2007 14:38:37 +0000

05 Dec 2007. Building on just one of its widely-acknowledged strengths – in peptide synthesis – Almac Sciences (Hall 16 Stand A75) is taking the opportunity of CPhI 2007 to position its “First in Man” approach.

This embraces and offers development of peptide synthesis, full analytical support (including method development and validation, reference standard, QA release and stability studies); GMP batches for Phase I and II (scaling from grammes to several kgs.), and finally support with CMC documentation.

It also stresses the strong connectivity between its cGMP peptide offering and other specialist capabilities within Almac Sciences – including 14C radiolabelling, cytotoxic conjugation and sterile formulation and filling.

Almac Sciences has capability to produce hundreds of peptides per month including conjugation to carrier protein if required. Bespoke custom work can typically include mgs to low gs, with cGMP at low kgs. A product listing includes natural/modified chemokines, with a specialization in long chain peptide synthesis. API production capacity is up to 100s g/batch.

Chemical synthesis capability:

In development of site-specific chemical modification of proteins, chemical synthesis of peptides and proteins has proved especially powerful. It enables numerous side-chain and backbone site-specific modifications to be incorporated into the primary sequence – providing a route for the increasingly sophisticated peptides required by the bio-community.

Almac Sciences has successfully developed a suite of both native and site-specifically modified chemokines. These have broad applications across research and drug discovery and are integral to methods employed by pharma and biotech to accelerate drug discovery.

Combining improved solid-phase synthetic methodology for step-wise chain assembly, tag based purification methods, peptides can be synthesised in high yield.

Service connectivity:

Almac Sciences has strong connectivity between its cGMP peptide offerings and other in-house niche capabilities. These include 14C radiolabelling, with several complex peptide and radiolabelling projects completed, together with cytotoxic conjugations to peptides, and sterile formulation and finishing.

Sterile formulation and filling is through partnership in the US with with Coldstream Laboratories, Lexington, Kentucky. This provides IV formulation and sterile fill for clinical trial applications through its innovative sterile manufacturing facility at the Research Campus, near Lexington.

The company is currently looking to add a European partner for sterile formulation and finishing, with an announcement expected within the next few months.

Part of the Almac Group, Almac Sciences is distinct for its capability to make very long peptides (60 – 100 mer) to GMP. The company’s main facility is its 80,000 sq. ft., £25m. HQ and laboratory complex in Craigavon, Northern Ireland, with additional R&D facilities near Edinburgh, Scotland.

Peptide Service offering:

Services include Clinical grade peptide supply, conforming to GMP ICHQ7A, with supporting development/documentation, with analytical packages and a stability package to support IND. Production is focused through a scale up GMP lab and small scale GMP lab, employing solid phase peptide Synthesis Technology, Fmoc chemistry for long peptides and in-process UV monitoring of coupling and de-protection.
In Purification Technology, RP-HPLC is employed for initial peptide purification, with API purity tailored to customer requirements (High Purity API 95 -99.9%). Isolation is via Lyophilisation in class 100,000 clean room, with Class 100,000 and 10,000 facilities for freeze drying of API and packaging in a class 10,000 environment
Scale up and optimization strategy is focused on developing/optimizing all areas of the total process, with emphasis (eg) on purification and freeze drying time to enhance throughput and serve the cost-of-goods agenda.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

Contact: Dr Rosaleen McGuckin

T: + 44 (0)28 3833 2200

E: sciences@almacgroup.com

W: almacgroup.com

The post Almac Sciences: “First in man” approach to peptides appeared first on Almac.

Almac Sciences Invest In Edinburgh Facility

admin — Thu, 08 Mar 2007 12:21:05 +0000

New half million pound investment will lead to eight new jobs in Elvingston

Almac Sciences has supported drug discovery, development and commercialisation through contract R&D, custom manufacturing and analytical services, since 1992. The service package has been steadily developed to include speciality offerings in cytotoxic and potent manufacturing; peptides, protein and oligo synthesis, chirals and radiolabelling.

The latest development is expansion of the division’s analytical services offering at its Elvingston facility, outside Edinburgh, with the addition of eight extra staff. The half million pound investment means there is now 27 staff employed at the laboratory in Elvingston. The new additional facilities were fully operational at the end of February 2007.

The investment, in the Analytical Services unit of Almac Sciences, will expand the company’s operations in bioanalysis, characterisation, stability testing, structure confirmation and batch release.

Head of Analytical Operations, Jon Cook said:

“The setting up of this new laboratory is an exciting opportunity. Across all divisions, our company is growing from strength to strength, and this investment is part of our overall growth strategy and ensures that we have the full capability to manage our customer requirements.”

Dr. Rosaleen McGuckin, VP Business Development at Almac Sciences said:

“These new services complement the existing service operations within Almac Sciences, as well as across the Almac Group. With Almac’s unique business model, we will be the leader in the generation of superior solutions for the advancement of human health.”

Ends

Contact

Carl Whyte

Stakeholder Group

02890 339949 / 017841 970678

Notes for Editors:

Almac Sciences is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

Almac Sciences operates from a £25m 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D center near Edinburgh, Scotland. The business has over 200 employees, including 120 scientists.

The post Almac Sciences Invest In Edinburgh Facility appeared first on Almac.

SafeBridge® Certification for Almac Sciences’ cytotoxics plant

admin — Wed, 14 Feb 2007 12:51:54 +0000

Pharma custom services innovators Almac Sciences – a division of the Almac Group – has announced SafeBridge® Certification in the safe handling of potent pharmaceutical compounds for its cytotoxic and potent compound manufacturing operations. Certification covers facilities, containment equipment, procedures and personnel training at the division’s Craigavon, Northern Ireland facility. SafeBridge Consultants, Inc. (SafeBridge®) is recognised for its high level safety, health and environment consultancy support to the pharma, biotech and chemical industries – with the potent compound Certification programme as a noted specialty.

Certification at Craigavon specifically embraces competency in the safe handling of materials in pre-clinical, clinical and commercial scale operations for the production of cytotoxic and potent APIs as well as radiolabelled syntheses. Included are the facilities for cytotoxic manufacture where barrier isolators (glove box technology) contained within dedicated suites are used for the safe handling of these compounds at the 80,000 sq. ft. production complex. These state-of–the-art facilities were expanded in 2003.

Development, kilo-lab and cGMP manufacturing suites have been designed to operate at 0.1μg/m3 OEL for cytotoxic compounds enabling manufacture of cytotoxic products at commercial scale. For potent compound manufacture, the cGMP manufacturing plant, (also operated at 0.1μg/m3 OEL) allows production at ~ ten fold higher levels.

SafeBridge® Certification is a respected benchmark in highly demanding pharma HPS operations that are focused on a handful of international players, including Almac Sciences. Commenting on the certification, Almac Sciences’ Commercial Operations VP Dr. David Moody said:

“This is a further enhancement of our package of supply chain solutions in all-scale production of cytotoxics and potent compounds. SafeBridge® Certification is the gold standard in this rapidly-growing sector of pharma services and sends a highly positive message to the customer and prospective customer communities”.

Dr Rosaleen McGuckin, VP Business Development, added:

“We are delighted to have such an important, independent certification of our facilities and philosophy for the supply of cytotoxic products to our customers.”

John Farris, CIH, President and CEO of SafeBridge® was part of the Certification and evaluation team. He noted:

“Almac Sciences have met our criteria for Certification through the application of engineering controls for the containment of powder handling operations, construction of modern contained facilities in the GMP Labs for kilo scale operations and implementing a comprehensive system of Standard Operating Procedures – including potent compound safety elements”.

Beyond cytotoxics and potents, Almac Sciences’ Craigavon facility has a wide range of connected capabilities in pharma contract services. They include R&D, custom manufacturing, analytical services, peptides, protein and oligo synthesis, chirals and radiolabelling.

SafeBridge’s® potent compound safety Certification programme verifies performance with set criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the programme include on-site assessment of production plant and equipment, training, toxicology, occupational hygiene and environmental control.

assessment of production plant and equipment, training, toxicology, occupational hygiene and environmental control.

Almac Sciences recently announced collaboration for cytotoxic and potent fill-and-finish services with the Center for Pharmaceutical Science and Technology – CPST, at the US University of Kentucky.

Focused on IV formulation and sterile fill for clinical trial applications, the agreement with CPST involves facilities at its new, US $17m. Coldstream research campus, near Lexington.

Other Almac Sciences highlights since mid-2006 have included the launch of Carbon 14 radiolabelling services, and commissioning of a £500,000 package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.

Notes for Editors:

- With capabilities across contract R&D, custom manufacturing and analytical services, Almac Sciences has been supporting drug discovery, development and commercialisation since 1992.Almac Sciences operates from a £25m., 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D center near Edinburgh, Scotland. The business has over 200 employees, including 120 scientists.
- The business is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.
- Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. In total, the Group employs 2,000 people in Northern Ireland, Scotland, England and the USA. See almacgroup.com
- Through its three companies, SafeBridge® provides professional scientific and engineering consulting services and analytical support to clients across the US and internationally, including the UK, Ireland, Continental Europe and Canada. SafeBridge® services also cover environmental health and safety; toxicology; industrial hygiene; analytical lab; safety and loss control and environmental services.
- Staff include occupational and environmental toxicologists, industrial hygienists and safety and environmental professionals. SafeBridge® has key offices in Mountain View California, New York and Liverpool, UK. See www.safebridge.com

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin	Roger Johnstone
VP Business Development – Almac Sciences	Deben Editorial Services
Tel: +44 (0)28 3839 5830	Tel: +44 (0)161 614 1450
Mobile: +44 (0) 7803 830775	Mobile: +44 (0)7841 433141
Fax: +44 (0)28 3833 2299	Fax: +44 (0)161 614 1450
rosaleen.mcguckin@almacgroup.com	rdj@debened.co.uk

The post SafeBridge® Certification for Almac Sciences’ cytotoxics plant appeared first on Almac.

Almac Sciences and BioCatalytics Inc. to co-operate on key pharma products

admin — Wed, 14 Feb 2007 12:29:02 +0000

Almac Sciences has announced a key chiral technology agreement with BioCatalytics Inc. – a leading global player in enzyme catalyst technologies. Under the agreement, effective immediately, Almac Sciences and BioCatalytics will co-operate on an exclusive basis for the development of processes and manufacture of a group of chiral intermediates and APIs. Clinical phase and launched products are covered at all scales.

Almac Sciences will scale-up and embed BioCatalytics’ technology in a range of

“manufacturing solutions”

, in line with its supply chain solutions and virtual manufacturing business model. The objective here, says Dr David Moody, VP Commercial Operations,

“is to provide Almac Sciences’ customers with the best manufacturing solution, sited in the most appropriate assets …anywhere”.

“Chirality is already a major strength within our portfolio of connectable drug development and commercialisation services. The ability to develop and apply BioCatalytics’ excellent chiral technology is a significant addition to our portfolio”.

BioCatalytics is best known for the global pharma services industry’s most comprehensive range of enzymes and related technologies for chemical synthesis, including major platforms for both resolution and chiral synthesis.

BioCatalytics’ President and CEO David Rozzell added:

“We look forward to working with Almac Sciences to commercialize processes using our proprietary enzymatic systems. Through this partnership customers will gain the benefit of BioCatalytics’ broad enzyme technology coupled with Almac’s manufacturing expertise for the production of key chiral intermediates and APIs”.

Based in Pasadena CA., BioCatalytics offers a range of enantiomerically pure chiral chemical compounds and custom services to support its capabilities in enzymes and drug metabolite synthesis. The company’s Human Cytochrome Biocatalyst product line won the CPhI Worldwide Gold Innovation Award in Paris last October. BioCatalytics extended its operations to Europe during 2006, establishing BioCatalytics Europe GmbH in Grambach, Austria.

Recent agreements:

The technology agreement with BioCatalytics is the latest in a series by Almac Sciences to connect with key technologies. The company most recently (7 February) announced a collaboration with the University of Kentucky’s Center for Pharmaceutical Science and Technology (CPST) for cytoxic fill and finish services for clinical trial applications.

The CPST agreement completed Almac Sciences’ supply chain solutions package in cytotoxics and potents – adding to significant in-house process research, development, manufacturing and logistics capability at its Craigavon, Northern Ireland complex.

Service package:

Almac Sciences supports drug discovery, development and commercialisation through contract R&D, custom manufacturing and analytical services. The package includes speciality offerings in cytotoxic and potent manufacturing; peptides, protein and oligo synthesis, chirals and radiolabeling.

In 2006, the division – part of the Almac Group – launched Carbon 14 radiolabeling services, and commissioned a US $1m. package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.

Notes for Editors:

Almac Sciences is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.
Almac Sciences operates from a £25m. 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D .center near Edinburgh, Scotland. The business has over 200 employees, including 120 scientists.
Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. Almac Group employs 2,000 people in Northern Ireland, Scotland, England and the USA. See also: almacgroup.com
Biocatalytics Inc. In addition to its range of enzymes and their process technologies, the company actively develops patented technology for the production of pharma. intermediates – including non-natural amino acids, beta-amino acids, chiral alcohols, chiral amines, amino alcohols and other chiral compounds.

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin		Roger Johnstone
VP Business Development – Almac Sciences		Deben Editorial Services
Tel: +44 (0)28 3839 5830		Tel: +44 (0)161 614 1450
Mobile: +44 (0) 7803 830775		Mobile: +44 (0)7841 433141
Fax: +44 (0)28 3833 2299		Fax: +44 (0)161 614 1450
rosaleen.mcguckin@almacgroup.com		rdj@debened.co.uk

The post Almac Sciences and BioCatalytics Inc. to co-operate on key pharma products appeared first on Almac.

CPST fill-and-finish agreement for Almac Sciences’ cytotoxics

admin — Wed, 14 Feb 2007 11:33:11 +0000

CPST fill-and-finish agreement for Almac Sciences’ cytotoxics

Almac Sciences is to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology – CPST, at the University of Kentucky. Under an initial agreement, CPST will provide IV formulation and sterile fill of cytotoxics and potents for clinical trial applications.

The contract will be delivered through CPST’s newly commissioned, highly innovative sterile manufacturing facility at the University’s Coldstream Research Campus, near Lexington. The US $17m. facility officially opened in May 2006.

This non-exclusive agreement with CPST completes Almac Sciences’ supply chain solutions package in cytotoxics and potents, for which it already has significant in-house process research, development, manufacturing and logistics capability at its Craigavon, Northern Ireland complex.

CPST General Manager Joe Wyse, Ph.D commented: “CPST is delighted at these opportunities to add Almac Sciences to a distinguished roster of major pharma and bio services players that have seen our ability to add value to their programmes – and to welcome them to our new Coldstream facility”.

Dr. David Moody, VP Commercial Operations for Almac Sciences, said: “Collaboration with CPST is an important link in completion of our supply chain in cytotoxics for clinical trial applications.

“This is another example of our commitment to specialised, interconnectable services that create powerful supply chain solutions. We will continue to meet our customers’ diverse and increasingly complex needs by combining Almac’s world class capabilities with the complementary services of other leading industry players”.

Almac Sciences’ business manager for cytotoxics programmes, Dr Rosaleen McGuckin, added: “CPST’s facilities and track record are impressive. Their sterile fill capability complements our upstream service offer in cytotoxics – and promises to similarly meet our emerging requirement in formulation of cytotoxic peptide conjugates”.

Dr. McGuckin emphasised that connection with CPST would benefit customers by significantly complementing Almac Sciences’ solid-dosage formulation capabilities – and by adding to its menu of project management and supply chain services.

Almac Sciences manufactures cytotoxic APIs in dedicated facilities, which were expanded in 2003 following significant investment. Packaging, labelling and distribution services for clinical trial supplies are provided through sister division, Almac Clinical Services.

Additional CPST capabilities:

In addition to cytotoxic and potent API containment, CPST’s 20,000 sq. ft. Coldstream facility, with a current staff of 25, has capabilities in non-sterile liquids and suspensions, sterile liquids; lyophilized product filling; APIs; biologics and advanced formulations.

CPST is a fully integrated, FDA-registered analytical and formulation development and pharma clinical supplies cGMP manufacturing facility. It has the capacity to develop and manufacture semi-solid dosage forms and solutions for safety/toxicity studies and Phase I and early Phase II clinical studies. Customers include pharma companies, leading bio companies, academic institutions and US federal agencies.

By 2011, the Coldstream facility is projected to have annual revenues of US $15m. and be employing up to 50 science-based and other professional staff.

Almac service package:

Through contract R&D, custom manufacturing and analytical services, Almac Sciences has supported drug discovery, development and commercialisation since 1992. The service package has been steadily developed to include speciality offerings in cytotoxic and potent manufacturing; peptides, protein and oligo synthesis, chirals and radiolabelling.

In 2006, the division – part of the Almac Group – launched Carbon 14 radiolabelling services, and commissioned a $1m. package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.

_______________________________________________

Notes for Editors:

Almac Sciences is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

Almac Sciences operates from a £25m. 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D center near Edinburgh, Scotland. The business has over 200 employees, including 120 scientists.

Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. Almac Group employs 2,000 people in Northern Ireland, Scotland, England and the USA. See almacgroup.com

Founded in 1986, CPST has completed well over 200 projects and grants focused on analytical formulation development and manufacture of existing drugs and NCEs. In addition to the Coldstream facility, the headquarters in Lexington – located in the College of Pharmacy and part of the University of Kentucky – has nearly 5,000 sq. ft. of lab and manufacturing facilities. See: www.cpst.com

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin Roger Johnstone

VP Business Development – Almac Sciences Deben Editorial Services

Tel: +44 (0)28 3839 5830 Tel: +44 (0)161 614 1450

Mobile: +44 (0) 7803 830775 Mobile: +44 (0)7841 433141

Fax: +44 (0)28 3833 2299 Fax: +44 (0)161 614 1450

rosaleen.mcguckin@almacgroup.com rdj@debened.co.uk

The post CPST fill-and-finish agreement for Almac Sciences’ cytotoxics appeared first on Almac.

Almac Sciences Scales Up for Peptides

admin — Tue, 10 Oct 2006 11:32:11 +0000

Almac Sciences Scales Up for Peptides

Almac Sciences (formerly CSS) has recently commissioned a £500,000 package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides. The move completes capabilities for highly flexible, milligrams-to-kilos peptide manufacturing.

Building on major existing investment, the latest developments are a logical step for a company with a strong reputation in the synthesis of extremely long peptides and the GMP manufacture of small molecules.

The synthesis and purification techniques that the company has devised to make GMP peptides of up to 170 amino acids in length are now being applied to clinical trial candidates of any size.

New investment at the large scale, multi-product site at Craigavon, Northern Ireland has included automated peptide synthesis equipment, preparative HPLC and a freeze drying suite. New equipment for small scale peptide synthesis has also been added to the inventory of Almac Sciences’ production and R&D center near Edinburgh. The sites are served by a combined team of over 20 peptide scientists.

VP Commercial Operations Dr. David Moody commented: “This latest investment package marks a significant addition to our suite of peptide capabilities – taking Almac Sciences into the ‘GMP at any length and any scale’ class”.

The developments form the first major announcement by Almac Sciences (ICSE Stand 4E77) since its mid-year namechange – from CSS – under the re-branding of the Almac Group.

Almac Sciences’ Senior Business Manager for peptides programmes, Denis Geffroy, commented: “This is a timely and important development for our customers. Application of Almac technology to the whole peptide space brings compelling quality, cost of goods and response time benefits to a new family of customers.”

Almac Sciences’ expanded range of peptide products and services includes:

A diverse range of site specifically labelled and native chemokines

Rapid supply of high quality custom peptides for antibody production

Mg to kilogram scale supply of custom peptides under GMP for clinical trials

Dr. Moody added: “This investment delivers our objective to provide customers with a mix of niche and mainstream offerings – from drug discovery stage services to large-scale production – between which they can make their own connections. The supply of peptide-cytotoxic conjugates is a recent example of this connected service in action.”

Previous 2006 developments:

The GMP peptide development is the latest in a series this year. Almac Sciences (when still CSS) introduced its Carbon-14 radiolabelling services commercially at InformexUSA in February. It can now radiolabel compounds at any stage between drug discovery and launch, including small molecules, peptides, oligos, cytotoxics and conjugates.

Also at Informex USA, the division launched its Chiral Building Blocks Package – which was further extended in April, just ahead of CPhI Japan, with the addition of (S)-Phenylbutyric acid.

The new range comes from the company’s work on bio-catalysis, both internally (Quinuclidinols) and in collaboration with IEP – covering Propylene Carbonate and Styrene Oxide, with Propylene Carbonate now ready for manufacture. These developments mark another success story for The Chiral Consortium, which the company co-founded in 2004. The other players are chemo-catalysis specialist ChiralQuest, of the US, and Germany’s bio-catalytic reduction technology leaders IEP.

Almac Sciences has a long established tradition in contract R&D, custom manufacturing, and analytical services. In recent years, this strong base has been augmented with speciality offerings; peptides, protein and oligo synthesis; cytotoxic and potent manufacturing; manufacture of chirals; radiolabelling – and now large scale GMP peptide manufacturing.

_______________________________________________

Notes for Editors:

Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. In total, the Group employs 2,000 people in Northern Ireland, Scotland, England and the USA.

In addition to Almac Sciences, the divisions are now: Almac Clinical Services (formerly CTS) focused on preparation and management of clinical trial supplies; Almac Clinical Technologies (formerly ICTI), specialising in integrated technology and service solutions to accelerate clinical trials; Almac Pharma Services (formerly PDMS) providing formulation development through to commercial scale pharma manufacturing and Almac Diagnostic Services (formerly ArraDx), providing gene expression profiling and generation of novel diagnostic products to improve patient management.

For further information contact:

Dr. Rosaleen McGuckin

VP Business Development – Almac Sciences

Tel: +44 (0)28 3839 5830

Fax: +44 (0)28 3833 2299

rosaleen.mcguckin@almacgroup.com

sciences@almacgroup.com

The post Almac Sciences Scales Up for Peptides appeared first on Almac.

CSS Radio Goes Live; Chiral Building Blocks Range Announced

admin — Thu, 16 Feb 2006 11:29:55 +0000

CSS Radio Goes Live; Chiral Building Blocks Range Announced

INFORMEX^® provided the backdrop for a twin North American launch by CSS (Booth#327) of its new Carbon-14 radiolabelling services and Chiral Building Blocks range. Both introductions play to the company’s “connections” agenda of adding strongly-differentiated capabilities to give customers a unique and powerful combination of services.

The radio labelling service was previewed in Europe in late 2005, but manufacturing started just last month (January) and the Chiral Building Blocks rollout is all-new.

CSS – Chemical Synthesis Services – is part of Northern Ireland’s ALMAC Sciences group and one of Europe’s leading providers of pharma chemistry, analytical and manufacturing services. CSS provides capabilities in contract R&D, custom manufacturing, analytical services, peptide, protein and oligo synthesis and chiral manufacturing.

Radiolabelling Service:

With completion of an initial investment programme in late 2005, CSS is now able to provide radiolabelling services for the development of compounds at any stage between drug discovery and launch. This additional CSS capability includes the labelling of peptides, oligonucleotides and cytotoxics. The service has been designed to be synergistic with the company’s long established offerings in the synthesis of metabolites and APIs.

“There is clear demand for this type of standalone service: sufficiently flexible to compete with existing providers and in an area of growing demand to meet often complex customer needs”, says CSS’ VP Commercial Operations Dr. David Moody.

“Specific differentiation comes from our GMP offering and builds as customers “connect” with our specialist chemistry capability. We can now synthesise and label just about any product entering clinical trials”, he adds.

Chiral Building Blocks:

CSS’ new Chiral Building Blocks package, unveiled for the first time at INFORMEX^®, consists initially of four key building blocks, with molecules all available in gram to tonne quantities. These are:

(R)-Propylene Carbonate

(R)-Styrene Oxide

(R)-3-Quinuclidinol

(S)-3-Quinuclidinol

The new range comes from the company’s work on bio-catalysis, both internally (Quinuclidinols) and in collaboration with IEP (Propylene Carbonate and Styrene Oxide) and marks another success story for The Chiral Consortium, which CSS co-founded in 2004. The other players are chemo-catalysis specialist ChiralQuest, of the US, and Germany’s bio-catalytic reduction technology leaders IEP.

“These productscan now bemanufactured anywhere and are therefore a superb fit with CSS’ ‘virtual manufacturing model’, says Moody. “We expect this approach to drive a major position for CSS as a recognised key supplier of chiral technologies combining quality, responsiveness and price competitiveness”, he added.

CSS operates primarily from a £25m., 80,000 sq. ft HQ and laboratory complex in Craigavon, Northern Ireland, opened in late 2003. Current facilities include two cGMP 50-600L production suites; small molecule kilo labs.; potent and cytotoxic manufacturing suites and state–of-the art R&D laboratories.

CSS has over 200 employees, including 120 scientists.

Notes for Editors:

The main portfolio of CSS’ technologies and services includes: Contract R&D (at lab-pilot plant scales), custom manufacturing – including process development, scale-up, validation, up to 100+ Kg cGMP manufacture; analytical services; cytotoxic process research, development and manufacture; peptide, protein and oligo synthesis; chiral manufacturing and isotopic labelling.

Capability in the chemical synthesis and purification of complex peptides is through the Scottish-based subsidiary CSS-Albachem. Based near Edinburgh, the company was established in 2004 when CSS acquired a controlling interest in Albachem.

In chiral manufacturing, CSS formed the world-leading Chiral Consortium in 2004. To CSS’ expertise in bio-resolution, route invention, scale-up and manufacture the Consortium adds the world-leading chemo-catalysis of US-based ChiralQuest and the bio-reduction capability of Germany’s IEP.

CSS, formed in 1992, is one of five divisions of the ALMAC Sciences pharma services group, operating across drug discovery, API manufacture, clinical trials and drug product manufacture. The group has facilities in the US, London and Northern Ireland.

ALMAC activities by division are: diagnostics (Almac Diagnostic Services); API contract research and manufacture (CSS); clinical supplies packaging, distribution and management (CTS); control and management of clinical trials (ICTI) and formulation, development and commercial scale manufacture and packaging of finished pharmaceuticals (PDMS).

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin

Roger Johnstone

VP Business Development – CSS Deben Editorial Services

Tel: +44 (0)28 3839 5830 Tel: +44 (0)161 614 1450

Mobile: +44 (0) 7803 830775 Mobile: +44 (0)7841 433141

Fax: +44 (0)28 3833 2299 Fax: +44 (0)161 614 1450

rosaleen.mcguckin@css-almac.com

rdj@debened.co.uk

The post CSS Radio Goes Live; Chiral Building Blocks Range Announced appeared first on Almac.

CSS Focuses on Australian Market

admin — Tue, 29 Nov 2005 11:25:03 +0000

CSS – (Chemical Synthesis Services) – one of Europe’s leading providers of chemistry and analytical services – announced at the recent AusBiotech Conference in Perth (20^th-22^nd November) that it plans to extend its global reach to the Australian Market.

The Company – part of Almac Sciences (www.css-almac.com) – believes that it has a strong proposition with the range of services offered and their interconnectivity.

Rosaleen McGuckin, VP Business Development of CSS comments; “At CSS we have a range of services that are individually attractive – from potent manufacturing and analytical services to Radiolabelling and Chirals – and compelling in combination. We believe that we are the only company to offer such a broad range of “connectable” services.”

CSS services are available to cGMP and includeMilligram to 100+ Kilogram synthesis; Synthesis of Cytotoxic and Potent Compounds; Access to world-leading Chiral Technologies; Isotopic Labelling; Peptide, Oligonucleotide and Protein Synthesis; Analytical and Bio-analytical Services (GMP and GLP compliant); stability studies (drug substance and drug product) and; contained micronisation.

The move into the Australian market follows a period of fast growth through internal investment, acquisition and partnership. In the past 3 years the company has invested £25 million (Aus$59.2 million) in buildings and equipment. The company employs over 200 worldwide including 120 scientists, with world leading experts in Peptides and Protein Syntheses; Chiral Technologies; Cytoxic Manufacture and Complex Organic Synthesis.

David Moody, VP Commercial Operations says;

“It seems to us that the highly innovative and expanding Australian biotech community will require improved access to diverse and integrated R&D and manufacturing services. We are determined to meet their most challenging needs with a value proposition second to none”.

CSS also recently made an exciting announcement about the launch of Carbon-14 labelling services on 01 Dec 2005. CSS will provide radiolabelling services for the development of compounds from drug discovery to launch of API. This full service provision will include: synthesis of metabolites; intermediates and API. In an unusual departure from the radiolabelling service provided by others, CSS will also offer GMP synthesis of Carbon-14 labelled API for clinical studies.

David Moody, VP Commercial Operations, comments; “This investment provides our customers with both a highly competitive stand-alone service and the opportunity to meet their most complex needs. In this regard, early indications are that many of our customers are interested in the supply of radiolabelled peptides, chirals and cytotoxics. This is another key step towards fulfilling our ambition of delivering diverse, differentiated and highly ‘connected’ services.”

CSS is an affiliated company of Almac Sciences which provides pharmaceutical services across drug discovery, manufacture of API, clinical trials and drug product manufacture.

Any companies interested in “connecting” with CSS should contact Rosaleen McGuckin on:

+44(0)28 38395830

+44(0)7803 830775

rosaleen.mcguckin@almacgroup.com

All Media Enquiries:

Darlene McCormick

life COMMUNICATIONS

Tel +44(0)2890 248805

Email: darlene@lifecomms.co.uk

sciences@almacgroup.com

The post CSS Focuses on Australian Market appeared first on Almac.

CSS Launches Global Provision of Radiolabelling Services

admin — Fri, 25 Nov 2005 11:24:03 +0000

CSS Launches Global Provision of Radiolabelling Services

CSS – one of Europe’s leading providers of chemistry, analytical and manufacturing services – announced today (01 Nov 2005) the launch of Carbon-14 labelling services on 01 Dec 2005.

CSS will provide radiolabelling services for the development of compounds from drug discovery to launch of API. This full service provision will include: synthesis of metabolites; intermediates and API. In an unusual departure from the radiolabelling service provided by others, CSS will also offer GMP synthesis of Carbon-14 labelled API for clinical studies.

CSS provides organic chemistry expertise, process development, manufacturing and technology transfer capabilities. It is an affiliate company of the Almac Sciences Group, which provides pharmaceutical services across drug discovery, manufacture of API, clinical trials and drug product manufacture. Its operations are based throughout the UK and USA.

Any interested companies should contact Rosaleen McGuckin at CSS on:

+44(0)28 38395830

+44(0)7803 830775

rosaleen.mcguckin@css-almac.com

All Media Enquiries:

Darlene McCormick

life COMMUNICATIONS

Tel +44(0)2890 248805

Email: darlene@lifecomms.co.uk

The post CSS Launches Global Provision of Radiolabelling Services appeared first on Almac.

CSS Albachem Secures a Share of £3.7 million R&D Programme

admin — Fri, 04 Mar 2005 11:23:17 +0000

CSS-Albachem – a Division of Craigavon-based Almac Sciences Group – has secured part of a £3.7 million R&D programme from ITI Life Sciences focused on the development of cell-based, pharmaceutical screening technologies to address a significant bottleneck in the drug discovery and development process.

This is the first programme launched by ITI Life Sciences and follows a detailed analysis of the pharmaceutical market and its existing and future needs for this technology. ITI Life Sciences is a new company driving Scotland’s ambitious plans to identify, develop and commercialise valuable technology-based intellectual assets in the life sciences sector. The group’s aim is to bridge the increasing funding gap between publicly funded early stage research and privately backed commercial development.

The three-year programme will take place in Scotland as a three-way collaboration between CSS-Albachem Ltd, Edinburgh Instruments Ltd and Hannah InterActions Ltd. Edinburgh Instruments is globally recognised in the development and manufacture of high-tech optoelectronics instrumentation whilst Hannah InterActions brings expertise in advanced cell based technologies specializing in cell function and its relevance to cancer. CSS-Albachem are acknowledged experts in the provision of complex and challenging peptides and proteins. Initially the programme is focused on developing instrumentation and cell-based screens for breast cancer, with plans to expand to other disease areas as the technology develops.

Cell-based screening is a key step in the drug discovery and development process where it is used to rapidly evaluate cellular mechanisms of disease as well as the effects of new drug candidates, such as distribution, metabolism or toxicity, in relevant cells.

This information is vital to pharmaceutical companies as it allows the selection of the most appropriate compounds to develop further. Three-dimensional cell cultures represent the most advanced model to date, providing a much closer representation of the biological environment in living organisms than previous biochemical models.

Approximately half of all assays used in this way are cell based and this represented a global market opportunity of US$750 million in 2004. ITI Life Sciences estimates this market will grow by 20% over the coming years and the use of sophisticated fluorescence-detection methods is set to account for two thirds of this.

In the ITI Life Sciences programme, the three participating companies involved will provide complementary expertise in order to develop and commercialise ‘Fluorescence Lifetime’ cell-based assay products, including ‘off the freezer shelf’ cells ready for screening, unique fluorescence-linked reagents and state-of-the-art optics and detection instruments.

David Moody, Vice President Commercial Operations said:

“We are delighted by this important development for us and our industry. We are committed to solving challenging problems for our customers from drug discovery to API supply. Partnerships such as this are important in achieving that end and will remain a feature of our strategy.”

CSS is a dynamic and entrepreneurial company, which has experienced excellent growth since its inception. CSS is Ireland’s leading provider of chemistry and analytical services to the pharmaceutical industry. CSS operates from sites in Northern Ireland and Scotland.

Almac Sciences and its affiliated companies (CSS, CTS, ICTI, PDMS, ArraDx) provide pharmaceutical services across drug discovery, manufacture of API, clinical trials and drug product manufacture. Operations are based in USA (Pennsylvania, North Carolina and California) and London in addition to Northern Ireland.

Notes to Editors

About CSS-Albachem

CSS-Albachem is a Scottish biotechnology company based near Edinburgh, founded on the science of Professor Robert Ramage, a world expert in the chemical synthesis and purification of peptides and proteins. The company is a leading player in the provision of complex and challenging peptides and proteins to the pharmaceutical and biotechnology industries for application in basic research, drug discovery, diagnostics and therapeutics development. CSS-Albachem is part of the Almac Sciences group and was established in 2004, when CSS acquired a controlling interest in Albachem.

CSS recently launched a collaboration with leading chiral technology specialists IEP and ChiralQuest in forming The Chiral Consortium.

Ref: Press Release December 2004

About ITI Life Sciences

ITI Life Sciences is a new company driving Scotland’s ambitious plans to identify, develop and commercialise valuable technology-based intellectual assets in the life sciences sector.

The group’s aim is to bridge the increasing funding gap between publicly funded early stage research and privately backed commercial development.

ITI Life Sciences is one of three new initiatives focused on important areas where Scotland has strong economic and business potential; the other areas are Techmedia and Energy. Each ITI has a minimum of £150 million from the Scottish government to invest over a ten-year period.

ITI Life Sciences operates a sophisticated business model to identify future emerging markets and business opportunities across all areas of life sciences and to evaluate Scotland’s ability to develop commercially viable solutions to meet future global market needs.

Where such opportunities arise, ITI Life Sciences will commission research to develop market-driven intellectual assets that can be commercialised by companies to stimulate long-term, sustainable growth in the Scottish life sciences sector.

For more information, see www.itilifesciences.com

About Edinburgh Instruments Ltd

Edinburgh Instruments (EI) was established in 1971 as one of the first spin-out companies of the Scottish University base. Positioning itself in the specialist optoelectronics instrumentation sector, EI has sold products throughout the world, with the export market accounting for 80% of its sales and a customer base that includes many multinationals as well as highly focussed academic research facilities. In more recent years EI has established a reputation in the field of lifetime fluorescence, with the Fluorescence Lifetime Spectrometer (FLS920) being the current lead product. The technology underpinning this instrumentation is pivotal to EI’s role in the ITI programme, which aims to maximise the advantages afforded by lifetime fluorescence, namely increased sensitivity, specificity and overall robustness, and to couple this with advanced optical components and analytical software to allow detailed interrogation of cellular processes.

www.edinst.com

About Hannah InterActions Ltd

Hannah InterActions Ltd (HIA), through its Hannah Cell Science division, provides cell-based products and cell-biological analysis to clients in the pharmaceutical and biotechnology

The post CSS Albachem Secures a Share of £3.7 million R&D Programme appeared first on Almac.

Chiral Consortium

admin — Tue, 21 Dec 2004 11:22:14 +0000

The cost-efficient synthesis of complex chiral products remains one of the greatest challenges in the manufacture of pharmaceuticals.

In a climate of globalisation of product sourcing and remorseless cost-cutting by major pharma, western suppliers have used chiral technology as a ‘business attracter’. The result has been a bewildering array of technology solutions – each touted as better than the rest with fine chemical companies vying for the title of leader in chiral technology.

CSS – one of Europe’s leading providers of chemistry and analytical services and an affiliate of the Almac Sciences group, – has now entered this arena.

‘The goal is to provide our customers with access to optimum manufacturing solutions while providing maximum flexibility in how those solutions are used,’ said Dr David Moody, VP Commercial Operations at CSS.

Of course, the key issue then is how to gain access to a chiral technology toolbox that merits the claim ‘world-leading’. Invent? Acquire? Again, CSS has a different approach.

‘Wonderful technology already exists in the hands of dynamic, entrepreneurial technology companies. We provide the route invention, scale-up, pilot manufacture and technology transfer – true partnership is the best answer,’ says Moody.

CSS has now formed ‘The Chiral Consortium’ with ChiralQuest and IEP. The Consortium will provide custom chiral synthesis (with manufacture at CSS’ site in Ireland); chiral building blocks and new routes to launched molecules. It looks like an impressive grouping:

ChiralQuest – a subsidiary of VioQuest Pharmaceuticals can claim to possess the broadest and deepest capability in asymmetric chemo-catalysis, thanks to the prodigious output of co-founder and Chief Technology Officer Prof Xumu Zhang. ChiralQuest’s proven technology provides cost-efficient access to an extremely broad range of amines, acids and alcohols.

Ron Brandt, CEO, ChiralQuest states: ‘ChiralQuest’s leading-edge technology represents a new generation of catalysts offering significantly improved turnover and frequency rates coupled with high enantioselectivity. Pharmaceutical and Fine Chemical manufacturers gain a valuable new synthesis resource through the combined efforts of this technology partnership.’

Similarly, IEP can justifiably claim to be the world-leader in bio-reduction technology. IEP’s technology has been proven at multi-tonne scale, and provides highly competitive access to diverse and challenging alcohols, diols and epoxides.

Of the Consortium, Ortwin Ertl, CEO IEP comments, ‘I am delighted to announce this partnership. Our customers will benefit from new derivatised molecules, capitalising on the superb chemical expertise of CSS from IEP’s innovative line of stereopure alcohols and epoxides. Novel stereopure alcohols are accessible in high volume via IEP’s EASOS-technology and superdehydrogenases.’

Will the Consortium expand? ‘We would be happy to welcome technology partners with as much to offer as the current membership. Of course, the trick is to have a compelling proposition for customers, and I think we have one,’ says Moody.

The post Chiral Consortium appeared first on Almac.

CSS Enters Chiral Market Through Collaborations with ChiralQuest and IEP

admin — Tue, 07 Dec 2004 11:20:53 +0000

CSS – one of Europe’s leading providers of Chemistry and Analytical Services – announced today (Tuesday 7th December 2004) that the company has entered the chirals market through collaborations with the world’s leading chemo-catalysis and bio-catalysis providers: ChiralQuest and IEP.

The move underpins CSS’ determination to combine its own innovation with that of the very best technology providers worldwide.

The new partnerships will enable CSS to:

a) Provide custom chiral synthesis: CSS will solve its customers’ challenging synthetic problems using tools provided by ChiralQuest and IEP. Manufacture will be at CSS’ cGMP facility in Northern Ireland

b) Supply Chiral Building Blocks: CSS will provide versatile chiral products in collaboration with each technology partner, taking advantage of manufacturing capacity, globally.

ChiralQuest – a subsidiary of VioQuest Pharmaceuticals, a publicly traded company in the US (VQPH) – is the world-leading provider of chiral chemo-catalytic technology, based at Monmouth Junction NJ, NY, USA. ChiralQuest’s proven technology provides cost efficient access to an extremely broad range of chiral amines, amino acids, acids and alcohols.

IEP is the world’s leading provider of bio-catalytic reduction technology, based at Rheingaustrabe 190-196 D-65203 Wiesbaden, Germany. IEP’s technology has been proven at multi-tonne scale and provides cost-efficient access to diverse and challenging chiral alcohols, diols and epoxides.

David Moody, VP Commercial Operations, CSS comments:

“This is a tremendously exciting opportunity both for us and the industry. We can now offer the pharma market right-first-time manufacturing solutions to complex synthetic problems using our innovative chemistry and the proven tools provided by ChiralQuest and IEP. We will also work with our partners to establish supplies of chiral building blocks hitherto unavailable or prohibitively expensive.”

Ron Brandt, CEO, ChiralQuest, states:

“ChiralQuest’s leading-edge technology represents a new generation of catalysts offering significantly improved turnover and frequency rates coupled with high enantioselectivity. Pharmaceutical and Fine Chemical manufacturers gain a valuable new synthesis resource through the combined efforts of this Technology Partnership with CSS.”

Ortwin Ertl, CEO, IEP adds:

“I am delighted to announce the partnership with CSS. Our customers will benefit from new derivatised molecules, created by the superb chemical expertise of CSS from IEP´s innovative line of stereopure alcohols and epoxides. Novel stereopure alcohols are accessible in high volume via IEP´s EASOS-technology and superdehydrogenases.”

The entry into the chiral market is an important development for CSS as it aims to become a major force in the provision of chiral products worldwide.

Any interested companies should contact David Moody at CSS on:

+44(0)28 38332200

+44(0)7739882442

david.moody@css-almac.com

All media enquiries:

Darlene McCormick Life COMMUNICATIONS on +44 2890 248805

The post CSS Enters Chiral Market Through Collaborations with ChiralQuest and IEP appeared first on Almac.

CSS Launches Unique Consortium at CPhI

admin — Thu, 28 Oct 2004 11:17:11 +0000

CSS – Ireland’s leading provider of chemistry and analytical services to the pharmaceutical industry – has strengthened its business proposition with the creation of a unique consortium, offering a comprehensive technology platform, with complementary technologies aimed at the same chiral target. The consortium was officially launched at the recent CPHI exhibition in Madrid.

CSS is an affiliate company of the Almac Sciences Group which provides pharmaceutical services across drug discovery, manufacture of API, clinical trials and drug product manufacture. Its Operations are based in USA (Pennsylvania, North Carolina and California) and London, in addition to Northern Ireland.

This latest development brings together 4 companies – CSS; Chiral Quest; IEP and Ingenza to create a consortium that will offer a single point of contact for global clients to access a broad range of world leading technology to make chiral drug intermediate.

The companies will collaborate in three main areas – Custom Synthesis; a selction of generic drugs; and a selection of chiral building blocks.

CSS leads the consortium and brings organic chemistry expertise, process development and manufacturing capabilities. CSS will also be providing six development personnel to cover the global pharma market. IEP will bring proprietary enzymatic technology to make chiral alcohols, diols and epoxides. Chrial Quest brings proprietary chemocatalysis technology to make chiral pharmaceutical intermediates and API. Ingenza brings a novel enzymatic approach to making chiral compounds (including Amines) by deracemisation.

David Moody, VP Commercial Operations , CSS comments:

“This is a tremendously exciting development for us – and for the industry – as we can, for the first time, offer the pharma market a single point of contact to access a broad range of the world’s must cutting edge technology in the chiral drug area.”

All media enquiries:

Darlene McCormick

life COMMUNICATIONS

Tel +44(0)2890 248805

Email: darlene@lifecomms.co.uk

The post CSS Launches Unique Consortium at CPhI appeared first on Almac.

CSS Acquires Controlling Interest in Peptide Company ALBACHEM

admin — Mon, 10 May 2004 00:00:00 +0000

10-MAY-04

CSS Acquires Controlling Interest in Peptide Company ALBACHEM

Custom Synthesis and API manufacturing company, CSS, has acquired a controlling interest in Albachem – a world leading peptide synthesis company servicing the pharmaceutical and biotechnology industries.

The strategic acquisition will strengthen the CSS service offering to global clients and further strengthen the company’s provision of niche speciality areas to the pharmaceutical industry.

Dr Stephen Barr, Managing Director of CSS, said:

“This acquisition further enhances CSS’s market differentiation through provision of specialist high technology services.

“It builds upon the chemistry expertise that is within the company and furthers our position at the interface between chemistry and biology.”

Professor Robert Ramage, founder and Scientific Director of Albachem, added:

“For Albachem, this validates our approach in offering robust synthesis of long chain peptides for the diagnostic and therapeutic markets.

“We can now expand our Research and Development capability to meet the changing needs of our established and future customers, throughout drug development. Provision of cGMP synthesis will be a key feature of the company.”

Albachem was founded by Professor Robert Ramage in 1994, within the University of Edinburgh, and moved to new facilities near Edinburgh in 2002. Its vision has been to service the anticipated need for advanced peptide chemistry in biotechnology following elucidation of the human genome. Albachem has developed superior and unique methods for the production of small protein structures that cannot be made by biological recombinant techniques. Professor Ramage and the existing expert team will continue to play a pivotal role in the development of the new company.

CSS is a dynamic and entrepreneurial company which has experienced excellent growth since its inception. CSS is Ireland’s leading provider of chemistry and analytical services to the pharmaceutical industry. CSS operates on three sites within Northern Ireland: Craigavon, Coleraine and Belfast.

Almac Sciences and its affiliated companies (CSS, CTS, ICTI, PDMS) provide pharmaceutical services across drug discovery, manufacture of API, clinical trials and drug product manufacture. Operations are based in USA (Pennsylvania, North Carolina and California) and London in addition to Northern Ireland.

All media enquiries:

Darlene McCormick Life COMMUNICATIONS on +44 2890 248805

The post CSS Acquires Controlling Interest in Peptide Company ALBACHEM appeared first on Almac.

Senator GEORGE MITCHELL Officially Opens New CSS Facility

admin — Mon, 01 Sep 2003 22:57:51 +0000

£25 (US $40) Million Investment in State-of-the-Art Facility for CSS

Senator George Mitchell today (1st September 2003) officially opened Almac House in Craigavon – the new Headquarters of CSS (Chemical Synthesis Services).

A capital investment of £25 (US $40) million in the 88,000 sq ft state-of-the-art facility for innovative sciences makes CSS Ireland’s largest chemistry service provider and strengthens the company’s position as a leading global provider of chemistry services.

The investment will have a positive effect on employment, with an additional 200 jobs being created over the next three to five years.

CSS is owned by Dr Allen McClay CBE, the founder and former Chairman of Galen Holdings plc. The company occupies a strategic position among the companies owned by Dr McClay, which also includes CTS (Clinical Trial Services) and ICTI (Interactive Clinical Technologies Inc). By 2006, approximately 1,400 people will be employed by these companies.

At today’s official opening, which was attended by international customers, local dignitaries, and CSS staff, Dr McClay, said:

“ CSS is an important link in the chain of services our companies provide for Pharma, Biotech and Virtual companies world-wide. In the provision of these state-of-the-art facilities it further strengthens our objective of becoming a global leader in this important sector.

“Increased job creation is one of the positive outcomes of the investment. This new facility will also enable CSS to further develop the global business opportunities that exist and to expand the services we offer in a range of new areas.”

Speaking at the opening, Ian Pearson MP, NIO Minister for Enterprise, Trade and Investment said;

“CSS is a dynamic and entrepreneurial company which has experienced rapid growth on the world stage in its formative years. These premises, which are on a par with the best in the world, indicate confidence in the further development of the company and send out a strong signal to the global market as to the leading edge research being carried out in Northern Ireland and the infrastructure which exists to support it.”

CSS operates on three sites in Northern Ireland. In addition to the Craigavon-based facility there is a Research and Development Facility at Queen’s University Belfast and an analytical services center in Coleraine.

Almac Sciences and its affiliated companies provide pharmaceutical services across a wide range of activities from drug discovery to process development and clinical trials. Additional Operations are based in USA (Pennsylvania, North Carolina and California) and London. CSS, CTS and ICTI were purchased from Galen Holdings plc over the past 18 months.

– Ends –

All media enquiries on CSS:

Darlene McCormick

life COMMUNICATIONS

Tel: 028 9024 8805

Dr Stephen Barr, CSS

Tel: +44 (0) 28 38 332200

NOTES TO EDITORS:

CSS is one of Europe’s fastest-growing contract chemistry companies, providing research chemicals and the full range of analytical services to the pharmaceutical, life science, fine chemical, agrochemical and related industries world-wide.
CSS was acquired from Galen Holdings PLC previously in January 2002 for £25 million.
CSS provides fully integrated support for activities from drug discovery through to Phase I, II, and III and commercialisation and offers its global customers a seamless service from basic R&D and small-scale synthesis to kilogram manufacture operating to cGMP and all supporting services.
The CSS customer base includes 16 of the top 20 Pharma companies worldwide as well as biotechs, virtuals and universities.

CSS services include:
research chemicals for library synthesis
route design and selection
multistage synthesis from grams to kilograms
process development and optimisation
cGMP production including potent compounds and cytotoxics for preclinical toxicology, Phase I, II and III and commercialisation
synthesis of reference materials, metabolites and impurities
analytical and bio-analytical services including method development, method validation and drug substance stability studies
micronisation and particle science services
The Center of Excellence for synthesis of oligonucleotides opened in January 2003. This is an important growth area in CSS’ business.
The 88,000 sq ft state-of-the-art laboratory complex has capacity for over 200 scientists.

New business areas as a result of the investment include:
a facility for the synthesis and handling of potent compounds (including cytotoxics)
a suite dedicated to the synthesis and manufacture of biological molecules including oligonucleotides, peptides and carbohydrates
high Field NMR and Mass Spectometry (MS) facilities
small-scale cGMP laboratories
a medium pressure hydrogenation suite
extensive new R&D and analytical laboratories, and separation science facilities

info@almacgroup.com

The post Senator GEORGE MITCHELL Officially Opens New CSS Facility appeared first on Almac.

API Services & Chemical Development Archives - Almac

Almac Sciences Launches New cGMP Flow Hydrogenation Capability

Almac invests £500,000 in state-of-the-art instrumentation within spectroscopy laboratories

Almac chemist recognised as “Future Leader” at CPHI Celebration Awards 2024

Almac Group announces £11m investment to expand global analytical services

Expert Analytical Solutions

Arran Chemical Company celebrates 40 successful years in business

Almac Sciences awarded Life Sciences Innovative Manufacturing Fund Grant

Almac Group Awarded six 2024 CDMO Leadership Awards

Almac Group Expands Commercial Manufacturing and Packaging as well as Peptide Production Capacity

Almac Sciences extends selectAZyme™ offering to include therapeutic oligonucleotide synthesis

Almac Sciences and HydRegen successfully complete first scale up of their joint development project

Almac selected as finalist for KTP “Best of the Best” awards

Almac Group opens a new custom-built GMP warehouse at its Global Headquarters

Almac Group Wins Life Sciences Team of the Year

Almac Sciences and University College Dublin BROADEN Continuous Flow Chemistry Collaboration

Almac Sciences successfully completes an outstanding Knowledge Transfer Partnership with QUB

Almac Sciences has been awarded the highest grade of “outstanding” by the KTP Grading Panel.

Almac Group Awarded with Six CDMO Leadership Awards Across all Core Categories

Almac Group Opens Registration for Internationally Recognised Process Chemistry Forum in Belfast

Almac Group secures HPRA certification for biologics testing

Almac Group Completes First Stage of GMP API Facility Expansion

Expanded GMP manufacturing facility now operational for use in clinical and / or commercial manufacturing

Almac’s Higher Level Apprentice success in WorldSkills UK National Competition

Odyssey Trust invests £3 million in state-of-the-art new centre to offer Learning Innovation for Everyone

Almac Group Hosts Internationally Recognised Chemistry R&D Forum in Belfast

Nordic-Irish Process Chemistry Conference re-scheduled to June 2023

Almac Sciences and UCD strengthen collaboration with prestigious SFI grant

Development of continuous flow enzyme cascade processes

Almac Group Expands Laboratory Scale Jet Milling Capabilities for Formulation and Toxicology Studies

Rising talent receives prestigious £1.5M UKRI Future Leaders Fellowship

Almac Sciences and Queen’s University Belfast Collaboration Successfully Flows Through Mid-point

Continuing to expand technology capabilities through Innovate UK funded Knowledge Transfer Partnership

Almac Group and PILA PHARMA Ink Manufacturing Agreement

Almac Group Announces Four-Year PhD Scholarship at UCL

Almac Group Completes £5million Research & Development Centre

Almac Group Further Expands Global Biologics Testing Solutions

Almac Group Granted Phase I Award Under the ‘Sustainable Innovation Fund’ to Aid COVID-19 Recovery

Almac Group Works to enable efficient manufacturing of remdesivir in Response to COVID-19

Almac Sciences Achieves Thought Leadership Milestone

Almac Group Appoints Vice President of Small Molecule API

Arran Chemical Company Continues Unique Industry – Academia Collaboration with Athlone Institute of Technology

Announcing a new four-year PhD scholarship to deliver greener and more economic alternatives to chemical production methods

Almac Group “CATCH”es a SFI Industry Fellowship

Collaboration with University College Dublin further expands its continuous flow platform

Almac Group Hosts Internationally Recognised Chemistry Forum in Belfast

Arran Chemical Company forms Unique Industry – Academia Collaboration with Athlone Institute of Technology

Almac Group Engages with Science Exchange to Promote US Small Molecule Analytical Services

Almac Group Flows into Continuous Technology

Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

Almac Group Launches Global Analytical Services Capability

Almac Group Launches GMP High Throughput Peptide Manufacturing Service

Almac Group Appoints David Taylor as Head of Manufacturing Operations

Almac Group Appoints Dr Stefan Mix as Head of Biocatalysis

Almac Group Launches Bespoke Elemental Impurities Laboratory

Almac Group Launches Second Line for High Throughput GMP Peptide Manufacturing

Almac Group Receives Annual Industrial Award from the Institute of Chemistry of Ireland

Almac Group Appoints Professor Tom Moody as VP of Technology Development and Commercialisation

Almac Group Wins Prestigious Research and Development Award

Almac to partner with ZYMtronix to deploy its universal enzyme immobilisation platform

NEW Fluorescence Lifetime Platform Unveiled at SLAS

Almac Acquires Arran Chemical Company and Expands Biocatalysis Services

Almac Group Appoints Dr. John Robson as VP Quality Operations

Almac Group Drives Biocatalysis Leadership with a Further $7M Investment

Almac wins Laboratory Team of the Year at The Irish Laboratory Awards 2013

Almac’s Strengthened Facilities Accommodates Demand of Late Stage API Manufacture

Novozymes Biopharma announces collaboration with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies

Almac Launches New [14C]-labelled ADCs Service Offering

Almac Receives FDA Inspection Approval

Almac Successfully Completes Knowledge Transfer Partnership with Queens University with Highest Accolade

Almac and TTP Labtech form alliance in fluorescence lifetime technology

Almac Concludes Commercial API Manufacturing Facility Expansion Plans

Almac and DSM Sign Collaboration Agreement in Biocatalysis

Almac Launches New Histone Reagents Catalogue and Custom Synthesis Service

Almac and VTU Technology form collaboration to provide customers with high yielding, fast-track generation of site-specific modified products

selectAZyme™ grows into metabolite synthesis

Almac Celebrates MHRA Audit Successes

MGB Biopharma and Almac Collaborate on Contract Manufacturing Project

Almac’s rapidd continuing to accelerate early stage development 2 years on

Almac Invests in New Commercial API Manufacturing