Pharmaceutical Development Archives - Almac

Almac Group Expands Bioavailability Enhancement Capabilities – Addressing a critical need in drug development

chloefinch — Tue, 09 Sep 2025 14:45:00 +0000

Almac Group has completed a multi-million-pound expansion of its bioavailability enhancement capabilities at its facility in Charnwood, UK.

The significant investment by Almac Pharma Services, will address ongoing industry challenges around solubility and growing global demand for advanced formulation solutions. The investment includes the installation of Buchi S300 and GEA PSD1 closed-loop spray drying technology and extensive expansion of the facility’s analytical laboratories.

This new technology, coupled with existing liquid capsule filling and non-sterile oral liquid formulation solutions at the facility, widens Almac’s bioavailability enhancement capability. The new technologies’ containment capabilities also complement existing potent-handling capabilities at the site.

This latest clinical investment expands on Almac’s long-standing pre-clinical expertise in bioavailability and amorphous solid dispersion development using a range of technologies including spray drying and melt extrusion. Almac also offers advanced particle engineering technologies and supporting analytical capabilities.

This expansion of market-leading technologies and expertise across Almac’s scientific teams now bridges the gap between pre-clinical and clinical drug development and gives clients even greater access to a range of advanced formulation approaches. This results in delivering a faster route to market for our clients, improved therapeutic performance and ultimately better patient outcomes.

James Hurst, VP Operations and Charnwood Site Head, Almac Pharma Services said: “This investment is a direct response to the growing demand for sophisticated formulation solutions. Spray drying is a cornerstone technology for enabling next-generation therapeutics, and our expanded capabilities ensure we remain at the forefront of pharmaceutical innovation. Our clients trust us to deliver precision, speed, and scientific excellence – this investment reflects our ongoing commitment to supporting clients with advanced technologies and expertise that drive success.”

This latest announcement builds upon the Group’s £11m investment in global analytical capabilities and comes just months after Almac Pharma Services officially opened its 100,000 square foot commercial manufacturing facility at its global headquarters in Craigavon, Northern Ireland. The £65 million facility further strengthens Almac’s end-to-end service offering, reinforcing the company’s ongoing commitment to expanding capacity, advancing technological innovation, and supporting clients worldwide with industry-leading pharmaceutical development and manufacturing solutions.

Find out more about our Bioavailability Enhancement Capabilities

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Almac Pharma Services Opens Doors on £65m New Commercial Manufacturing Facility

thomasdrake — Tue, 11 Mar 2025 16:00:00 +0000

Almac Group has today announced the official opening of a new, state-of-the-art, £65m commercial manufacturing facility for Almac Pharma Services at its global headquarters in Craigavon, Northern Ireland.

The new 100,000sq ft facility enhances existing capabilities in commercial manufacture of oral dose treatments for a variety of therapeutic areas. The high-specification production suites, managed by Almac Pharma Services’ experienced scientific and operational teams, are fully equipped with the latest in pharmaceutical manufacturing technology and includes an extension to current production scales of potent and highly potent drug products.

Construction of the building was completed in late 2024 and following successful completion of validation activities, manufacture of GMP batches will commence next week (18th March) in the regulatory approved facility. This Centre of Excellence has been designed with flexibility and a wide range of uses in mind and includes opportunities for partner companies to install custom and / or dedicated technology tailored to their individual and emerging pipeline needs.

“We are thrilled to officially open our new commercial manufacturing facility at our global headquarters site,” said John McQuaid, President and Managing Director, Almac Pharma Services. “This investment underscores our commitment to supporting our clients’ growing needs with the highest level of service and expertise.

“The new facility not only expands our range of capabilities but also reinforces our position as an industry leader in pharmaceutical development and commercial manufacturing with an ability to tailor our services to suit individual products. It also demonstrates our commitment to working in true partnership with our clients as we support them in bringing important new therapies to the patients we serve.”

This £65 million investment by Almac Pharma Services in Craigavon marks a significant milestone in Almac Group’s ongoing global expansion programme. Almac Group initially committed to £250 million in capital investment and a growth of 1,800 new jobs across the Group globally in 2022. Since then, the Group has increased its projected investment figure to over £400 million.

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Almac Pharma Services expands with exciting career opportunities

thomasdrake — Wed, 26 Feb 2025 15:52:49 +0000

Almac Pharma Services is hosting an information day at the Seagoe Hotel, Portadown on Tuesday 1^st April from 12pm to 7pm.

Almac is actively recruiting for a range of roles based at the headquarters in Craigavon, which are available to suit people no matter what their qualifications or experience. All of the jobs offer a competitive salary and huge potential to progress in a rewarding and varied career.

There are opportunities available within manufacturing and packaging operations, including Grade II and III Senior Operators with various shift patterns including early/late rotating shift and permanent night shifts. Salaries range from £33,998 for a Grade II position (early/late rotating shift) up to £44,638 for a Grade III position (continental night shift).

The company is also hiring Graduate Production Technicians suitable for individuals with a third level education (e.g. HNC, HND (or higher) in a Life Science or Engineering subject), and no previous experience. This offers a clear career pathway where successful hires can expect to progress to a Production Technician within two to three years, dependent on performance.

There are numerous opportunities available for Production Technicians aimed at individuals with significant relevant experience working within the pharmaceutical industry or in an engineering environment.

Representatives from operations and engineering will provide company overviews with more information on the type of roles available, career pathways across the Almac Group and an insight into the company culture. HR representatives will also be present to provide advice on completing application forms and discuss the benefits that exist within Almac.

Tom Hegarty, Director, Operations – Manufacturing, Almac Pharma Services said: “We are excited to open our doors to passionate and talented individuals who are keen to make a difference in the pharmaceutical industry.

“Our open day is a fantastic opportunity to learn about the diverse and rewarding career paths at Almac Pharma Services. Join us to meet our dedicated team, explore our innovative roles, and discover how you can grow with us. We look forward to welcoming you and helping you take the next step in your career journey.”

To find out more about the roles or register for our recruitment event visit – https://www.almacgroup.com/careers/recruitment-open-day-craigavon/

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Almac Pharma Services announces recruitment event following major expansion at Craigavon HQ

thomasdrake — Mon, 28 Oct 2024 14:33:39 +0000

Almac Pharma Services, is hosting a recruitment event at the Crowne Plaza Hotel, Belfast on 25th November from 4pm to 7:30pm.

Almac is actively recruiting for over 30 roles to suit people no matter what their qualifications or experience. All of the jobs offer a competitive salary and huge potential to progress in a rewarding and varied career.

The recruitment event will give prospective applicants the opportunity to learn more about the work of Almac Pharma Services and an insight into the company’s culture from managers and team members. HR representatives will also be on hand to provide advice on completing the application form and to discuss the benefits and progression pathways that exist within Almac.

Available roles include Technicians, Specialists and Team Leaders within the Production, Operations, Analytical and Quality teams as well as Formulation Development and Technical Specialist roles within its Scientific, Engineering, and Technical departments. The company is also looking for individuals with previous project management experience for a variety of rewarding roles across its multiple client-facing departments.

Mark English, VP Operations at Almac Pharma Services commented: “This is a fantastic opportunity for individuals to join our growing team and contribute to our mission of advancing human health. With the recent expansion of our facilities, we are excited to offer a wide variety of roles that cater to a huge range of individuals regardless of their qualifications and experience. We look forward to welcoming prospective applicants and showcasing the rewarding career paths available within Almac.

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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.

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Almac Pharma Services Appoints New VP Finance

brendanhagan — Mon, 30 Sep 2024 12:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Samantha Fitzpatrick as its Vice President of Finance.

As part of Almac Pharma Services’ executive leadership team, Samantha will oversee financial planning, analysis and accounting. In addition, she will collaborate with global department heads to progress a business partnership approach aimed at transforming financial reporting and systems to enhance availability and clarity of financial information. This will facilitate improved decision-making across all aspects of the organisation and support the next phase of growth for the organisation.

Samantha holds a BA (Hons) in Accounting and is a member of the Institute of Chartered Accountants Scotland (ICAS). She has over 15 years of experience in financial leadership roles within Fast-Moving Consumer Goods (FMCG) organisations, including Irwin’s Bakery and Moy Park. She has a proven track record in supporting strategic business growth and joins Almac from Finnebrogue Artisan where she served as Deputy Chief Financial Officer and Financial Controller.

“We are delighted to welcome Samantha to the Almac Pharma Services executive team,” commented John McQuaid, President and Managing Director, Pharma Services. “Samantha’s extensive experience, skill set and leadership will be instrumental in guiding Pharma Services through our next phase of growth. We look forward to the positive impact she will undoubtedly bring to our business.”

The appointment comes just months after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

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Almac Pharma Services Joins European Paediatric Formulation Initiative (EuPFI)

thomasdrake — Fri, 30 Aug 2024 08:00:00 +0000

Charnwood, UK – 30 Aug 2024 – Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, is proud to announce it has become a member of the European Paediatric Formulation Initiative (EuPFI).

EuPFI is a consortium dedicated to formulating better medicines for children. Their workstreams focus on critical aspects of pediatric formulation development, including age-appropriate formulations, administration devices, taste masking, pharmaceutical excipients, and biopharmaceutics.

As part of EuPFI, Almac Pharma Services’ can contribute to improving access to paediatric medicines by sharing their expertise in this field and collaborating with other industry, academic and regulatory expert partners to identify innovative solutions to the challenges associated with developing medicines for children. By aligning with EuPFI’s mission, Almac will continue its contribution to improving pediatric healthcare worldwide.

Prof Catherine Tuleu, EuPFI’s Founder, added: “We are delighted to partner with Almac to advance ‘little humans’ health! Their unique tailor-made pharmaceutical development and commercial solutions towards paediatric & age-appropriate formulations, as well personalised medicines, is a welcome synergistic addition to our consortium.”

Terry Ernest, Director of Manufacturing Science and Technology, Almac Pharma Services, commented “With over 55 years development experience across Almac, our experts specialise in the design, development, manufacture and packaging of age-appropriate drug products. Becoming a member of the EuPFI enables us to contribute meaningful insights and collaborate with other members as we work together to advance pediatric medicine.”

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Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities

brendanhagan — Tue, 23 Jul 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, is delighted to announce the successful completion of its first US Food and Drug Administration (FDA) inspection of its commercial manufacturing facility in Charnwood, England.

The pre-approval inspection which took place over the course of five days was in relation to a solid oral dose product which the site will manufacture for a global pharmaceutical company. On completion, the inspector concluded the facility, systems and practices comply with FDA requirements with no Form 483 observations or comments reported.

Since its acquisition in 2015, Almac Pharma Services’ facility, which is set within the Charnwood Campus in Loughborough, has experienced significant growth and now employs over 250 highly skilled and experienced individuals. The site provides a wide range of oral dose development and manufacturing specialising in high potency and age-appropriate treatment options.

This successful FDA inspection marks a significant milestone as it represents the final Almac Pharma Services’ site to receive FDA approval. This achievement now complements the existing FDA-approved facilities at the company’s global headquarters in Craigavon, Northern Ireland, Dundalk, Ireland, and its US facility in Audubon, Pennsylvania. It also further reinforces the company’s commitment to upholding the highest standards of quality as it experiences significant growth across its product development, manufacture and commercialisation services to meet ongoing client needs.

Almac Pharma Services’ Vice President, Quality, Ian Markwell commented: “This milestone underscores our commitment to maintaining the highest quality standards and regulatory compliance enabling us to consistently deliver best-in-class services to our clients. With this achievement, we continue to strengthen our position as a trusted, reliable and stable partner as we work together to advance human health for the sake of patients in need.”

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Almac Pharma Services Supports Rapid Launch of BioLineRx’s APHEXDA® (motixafortide)

brendanhagan — Tue, 18 Jun 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has successfully supported the commercial packaging and rapid launch of BioLineRx’s APHEXDA® (motixafortide) into the US market.

APHEXDA®, which is administered by injection, was approved on 11 September 2023 by the U.S. Food and Drug Administration (FDA) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. It is estimated that more than 35,000 people will be diagnosed with the disease and 13,000 will die due to the condition in the US in 2023, according to the American Cancer Society. The symptoms of the disease include bone pain or fracture, low red blood cell counts, fatigue, high calcium levels and kidney problems or infections.

A multi-departmental team comprised of specialists from Almac’s New Product Introduction (NPI), Planning, Quality Control, Quality Assurance and Artwork departments collaborated with the BioLineRx team to gain a full understanding of the product, approval timelines, various considerations, handling and distribution requirements.

Leveraging Almac’s expertise and experience in launch programmes, the teams worked in true partnership to assess various launch models and together agreed a tailored framework to efficiently, and effectively prepare, label and pack the treatment for immediate distribution upon FDA approval ensuring patients’ needs were met on time.

Asaf Aloni, VP Global Supply Chain, BioLineRx commented: “We engaged with Almac Pharma Services about a year before the expected launch. Almac’s teams worked tirelessly and professionally to help BioLineRx launch successfully on the date set by the company. Almac’s true strength lies in its employees and their dedication to help clients achieve their goals.”

Grainne Hughes, VP Business Support Operations, commented: “Congratulations to BioLineRx on this fantastic achievement. We are pleased to have shared our knowledge and experience with the team to enable the successful rapid launch of this much needed therapy to patients in the US. We wish BioLineRx continued success as we look forward to developing our partnership to supply many more patients in the years ahead.”

Almac Pharma Services’ reliability and commitment to partnering to advance human health is most visible through key partnerships with companies such as BioLineRx, who are working to advance life-changing treatments and therapies to patients.

As part of the Group’s ongoing global expansion investment totalling £400m, the company recently announced the completion of a 32,000 square feet custom-built high-volume facility that significantly increases its existing commercial manufacturing and packaging capacity.

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Almac Pharma Services Appoints New VP of Business Development

thomasdrake — Tue, 04 Jun 2024 08:00:00 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Simon Wright as its new Vice President of Business Development.

In his new role, Simon, who holds a BSc in Chemistry, will oversee Almac Pharma Services’ global business development and marketing strategy, in addition to supporting the Senior Leadership team in managing strategic business relationships with existing clients and developing opportunities to drive growth and market expansion for the business.

With a career spanning 30 years, Simon brings a wealth of experience in global business development, strategic leadership, and client relationship management. Most recently, Simon held the position of Head, Global Commercial Operations for Argenta where he was responsible for the management of new and existing customer relationships. Prior to this, he spent over 2 decades with Catalent where he held various senior business development roles and executed effective strategies for building strong relationships with internal teams and customers.

Welcoming Simon to the role, John McQuaid, President and Managing Director, Almac Pharma Services said, “We are delighted to have Simon on board. His experience, coupled with his deep industry knowledge and proven track record of developing successful partnerships, is a vital addition to our senior leadership team. We look forward to working with him as, together, we drive continued growth and success for Almac Pharma Services.”

The appointment comes just 2 months after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

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Almac Pharma Services Supports Industry Consortium to Address Titanium Dioxide Alternative Challenge

brendanhagan — Tue, 30 Apr 2024 08:56:20 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the completion of multiple assessments in support of a global pharmaceutical industry Consortium to help address the challenge of titanium dioxide (TiO₂) usage in drug products.

With over 50 years’ experience in product development and an established reputation for oral dose formulation expertise, Almac Pharma Services was selected by the Consortium to support the critical investigation into TiO₂-free systems with the aim of future proofing the delivery of safe and effective solid oral treatment supply to patients in need.

Due to its unique properties, TiO₂ has been used as a colourant, opacifier and for protection from UV radiation on solid oral dosage forms for decades. In 2022, following an assessment by the European Food Safety Authority (EFSA), the EU commission banned TiO₂ from use in food but allowed its ongoing use in medicines upon the recommendation of the EMA, with a further review scheduled for April 2024. The European Commission is expected to make a final decision on the ban in February 2025 following the update EMA assessment^[1].

To coordinate activities and deliver an industry-aligned assessment, a grouping of (>20) industry leading pharmaceutical companies was formed in 2022 to collectively address this via a new pre-competitive industry Consortium. The aim of the ‘Alternatives Consortium’ was to generate evidence that can be used by the EMA to support the re-evaluation of the feasibility of removing TiO₂ from the list of excipients for use in medicines.

In preparation for the pending EMA review, the time sensitive project was initiated in March 2023 and members of the Consortium provided a full brief of the requirements. In true partnership with key members of the group, Almac’s scientific experts conducted multiple assessments with respect to the processibility and manufacture of TiO₂-free options based on their effectiveness, impact on product and general technical feasibility.

Upon completion of the 12-month investigation involving a significant volume of testing, and meeting all key milestones throughout the project, Almac provided a comprehensive range of observations and significant data sets enabling the Consortium to submit their final report to the EMA.

Alan Carmody, TiO₂ Alternative Consortium, experimental and data interpretation work stream lead: “When the consortium approached Almac we set out a significant challenge to evaluate 34 different film coat systems and 17 hard shell capsule systems. Almac accepted the challenge and have been excellent partners showing resilience and flexibility to meet our requirements and produce the comprehensive data package we required for our submission to the EMA.“

John McQuaid, President & Managing Director, Almac Pharma Services commented on the partnership: “We recognised the enormous challenge a potential ban on titanium dioxide usage could have for many products across the industry. Being able to partner with a global Consortium to support this crucial investigation into suitable TiO₂ alternatives has been incredibly rewarding for our teams as we worked together to find a solution to safeguard patients now, and in the future.”

Last month, Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

[1] https://www.raps.org/News-and-Articles/News-Articles/2023/11/Pharma-groups-fight-proposed-ban-on-titanium-dioxi

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Amicus Therapeutics Inc and Almac Pharma Services Mark 15-year Strategic Partnership with Patient Advocacy Event

admin — Mon, 22 Apr 2024 12:59:41 +0000

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has celebrated a key milestone of its strategic partnership with global biotechnology company, Amicus Therapeutics Inc, by hosting a patient advocacy event for its employees.

Almac Pharma Services commenced their relationship with Amicus in 2009 by providing product development and clinical manufacture services and continued its successful partnership as the drug moved into commercialisation after gaining FDA and EMA approval. Almac’s expert teams has now provided fully integrated, end-to-end commercial manufacture, packaging and distribution solutions to Amicus for over 15 years from its Craigavon headquarter facility ensuring reliable and efficient global distribution to meet ongoing patient demand.

To mark the occasion, on 17^th April, Almac Pharma Services welcomed Amicus Therapeutics’ Chief Patient Advocate, Jayne Gershkowitz along with several patient advocates, who shared their experiences of living with a rare disease with Almac’s employees. The two-hour information session offered a unique opportunity for team members from across multiple departments including packaging, distribution, project, quality and engineering to hear, first-hand, from patients about their journey from rare disease diagnosis to treatment and the impact this has had on their lives.

Andrew Harrison, Packaging Team Leader, an Almac Pharma Services employee for over 30 years, attended the event and commented: “This patient advocacy event has given us all the opportunity to learn more about the impact a disease has on, not only the patients, but their families too. Hearing from individuals about their lived experience in this way enables us to gain a deep understanding and appreciate the positive contribution we are making every single day to healthcare.”

Grainne Hughes, VP Business Support Operations, Almac Pharma Services, stated: “We are extremely proud of the strong, global reputation that Almac has built over the last 55 years as a trusted and stable CDMO partner.

“Partnering with the Amicus team to support the ongoing supply of their drug has been hugely rewarding for our team. Knowing that our support is contributing to patient health in this way is clear motivation to ensure we continue to provide best-in-class, tailored services to our clients. We thoroughly enjoy working with Amicus and look forward to our continued partnership.”

Jayne Gershkowitz, Chief Patient Advocate, Amicus, commented: “Celebrating our 15-year partnership with Almac is an important milestone, and a testament to the significance of shared vision in supporting the rare disease community. We are honoured to be part of this event and bring the perspective of patients to Almac to inspire the team to continue its important work of making medicines that improve the lives of people with rare diseases.”

Just last month, as part of the Group’s ongoing global expansion investment totalling £400m, the company announced the completion of a 32,000 square feet custom-built high-volume facility that significantly increases its existing commercial manufacturing and packaging capacity.

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Almac Pharma Services Appoints New Director of Manufacturing Science and Technology

admin — Thu, 04 Apr 2024 07:58:00 +0000

Craigavon, UK – 4 April 2024 – Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has announced the appointment of Terry Ernest as its new Director of Manufacturing Science and Technology.

Terry has extensive experience within the pharmaceutical development and manufacturing industry, including a deep knowledge of a variety of dose forms including modified release formulations, tablets, capsules, oral liquids and sterile liquids.

A Chartered Biologist with a Masters Degree in Industrial Pharmacy and PhD in Pharmaceutics, Terry joins Almac from GSK where he held a number of senior positions over his 30 year tenure, including his most recent role as Director, Product Development at its site in Ware, UK.

As a subject matter expert in age-appropriate drug development, Terry is a member of several paediatric focus groups in addition to multiple product development industry bodies and has published a number of papers on the topic. He has also been invited to deliver technical presentations at global conferences and industry events throughout the last 20 years.

James Hurst, VP Operations & Charnwood Site Head, commented on Terry’s appointment “We are delighted to welcome Terry to our team of established experts. His vast experience and product development expertise will provide additional technical support to our growing client base. His appointment comes at an exciting time as we proceed with our strategic growth plans by investing in our facilities, technology and our most vital asset, our people, as we continue to offer our clients, and ultimately patients across the world, a best-in-class service offering.”

Terry’s appointment comes just weeks after Almac Pharma Services announced the completion of a custom-built, high-volume facility significantly increasing its commercial manufacturing and packaging capacity, forming part of the Group’s ongoing global expansion investment programme totalling £400m.

#ENDS#

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

Employing over 1,600 highly skilled individuals across 4 locations in Europe and the US, the company provides tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.

To keep up to date with latest news, follow us on LinkedIn or visit our website.

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, now employing 7,200 highly skilled personnel across 18 facilities including Europe, the USA and Asia.

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

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Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

admin — Wed, 20 Mar 2024 14:42:54 +0000

Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies

New Drug Application (NDA) submission to the FDA planned for second half of 2024

CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services, a member of the privately owned- Almac Group, as dual supply sources for the potential launch and commercialization of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S.

‘‘Dual sourcing is a critical element for the successful commercial launch and supply chain management of a product,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to advance our first internally developed program toward NDA submission and to work with two well-established CMOs for commercial supply and potential launch of Tonmya.”

“Having supported the development and clinical trial supply of this drug, we’re thrilled to be continuing our partnership with Tonix to support the commercial launch and ongoing supply of this important new non-opioid analgesic to patients with fibromyalgia, a chronic debilitating disease.” said Mark English, VP Operations, Almac Pharma Services.

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed.

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia.

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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.

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Almac Pharma Services Renew HPRA GMP Certification for European Facility

evewallace — Mon, 12 Feb 2024 14:46:40 +0000

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has received renewal of The Health Products Regulatory Authority (HPRA) Certificate of GMP Compliance for the company’s European facility.

The achievement comes following an in-depth, on-site 5-day audit conducted by an HPRA inspector from 6^th – 10^th November. The certification applies to all labelling, secondary packaging including specialist ultra-low temperature processing, analytical and distribution activities performed at the company’s Dundalk, Ireland facility.

The audit was overseen by Andrew Spence, Almac Pharma Services’ Head of Quality Assurance, and Fiona McDonnell, Dundalk’s Quality Manager supported by multiple subject matter experts from across Almac Pharma Services’ production, warehouse, labs, QP, global QA and technical quality teams.

The multi-departmental collaboration exhibited throughout this regulatory inspection, and our ability to maintain our reputable high standard of on time, in full (OTIF) service levels throughout the week, is testament to the commitment and professionalism of the entire Almac Pharma Services’ team.

Ian Markwell, VP Quality Assurance, Almac Pharma Services, said: “As a trusted partner to hundreds of global pharmaceutical clients we are committed to delivering best-in-class, tailored and quality-led services. The renewal of our HPRA certificate is a clear reflection of how our people, infrastructure, policies, systems and skills combine to achieve excellence for our customers. Thank you to everyone who contributed to the successful outcome of this inspection at our Dundalk facility, and I look forward to continued growth of this site in the coming years.”

Almac Pharma Services’ Dundalk facility is one of four operational sites and is a dedicated Centre of Excellence offering Just-in-Time labelling, packaging and serialisation of all pharmaceutical products including advanced therapeutical medicinal products which are often handled at ultra-low temperatures (-20°C to -80°C).

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Almac Pharma Services Receives Brazilian ANVISA GMP Certification for US Facility

brendanhagan — Tue, 14 Nov 2023 13:07:16 +0000

Almac Pharma Services, a member of the Almac Group providing product development, manufacturing and commercial services to global pharmaceutical and biotech organisations, has received its ANVISA GMP Certificate for the company’s Pennsylvanian facility, which approves the site for supply of products into Brazil.

An ANVISA GMP certificate is issued by the Brazilian Health Regulatory Agency (ANVISA) to confirm that an establishment complies with the technical requirements of Good Manufacturing Practices (GMP) needed for commercialising a product, according to the current law.

The facility, located in Audubon, is an established, FDA approved site offering a range of specialist pharmaceutical product launch and commercial supply solutions including complex patient kit processing and complements Almac Pharma Services’ three European locations.

Harry Lindenmuth, VP Operations and Audubon Site Head, Almac Pharma Services, said: “This certification marks an important regulatory milestone for our facility in Audubon, PA. It represents further evidence of our continued commitment to offering best-in-class, quality-led and tailored services for our clients, and the patients they serve.

“This accomplishment is testament to the continued progress in developing the site by the Audubon team. Congratulations to everyone involved in making this possible. We look forward to the continued growth of Almac Pharma Services in the US.”

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Almac Group releases details of £80 million expansion in Northern Ireland

brendanhagan — Thu, 19 Oct 2023 09:00:00 +0000

Expansion will create 550 jobs in 140,000ft² development and manufacturing facilities

The Almac Group has today announced details of an £80 million investment programme to build new extensive manufacturing, production and diagnostic laboratory facilities at its Global Headquarters in Craigavon, Northern Ireland.

The construction of these two significant facilities will create over 550 jobs locally, spanning a range of lab and non-lab-based roles, with recruitment already commenced for some positions. This is part of the company’s international recruitment drive which is expected to create 1,000 jobs in Northern Ireland over three years.

The expansion, which is part of the global investment programme announced in 2022, will significantly grow operations for two of the Group’s business units, Almac Pharma Services and Almac Diagnostic Services.

Almac Pharma Services supports the development and commercialisation of new treatment options for a wide range of therapy areas including oncology and immunology. Almac Diagnostic Services offers a range of biomarker discovery, development and commercialisation solutions to Biopharma partners globally.

The first of these two major projects is a 100,000ft² state-of-the-art multi-product Good Manufacturing Practice (GMP) facility for Almac Pharma Services. This Centre of Excellence for manufacturing will house a custom designed dispensary area, multiple production suites, process equipment wash facilities and a lineside warehouse for ambient, refrigerated and frozen storage. The new facility will primarily support solid oral dose products, complementing Almac’s existing capabilities in this area.

The facility, which will be operational from Q3 2024, will expand Almac Pharma Services’ existing manufacturing capabilities and offers additional capacity for further strategic production contracts. The high-specification production suites have been designed with flexibility and a wide range of uses in mind which offers opportunities for clients to install bespoke technology specific to their individual needs.

The second project is a 40,000 ft² four-storey diagnostic development and manufacturing centre for Almac Diagnostic Services which will be completed by Q1 2024. The new facility will enable Almac Diagnostic Services to expand its assay development offering and to manufacture and distribute Companion Diagnostic (CDx) kits on a commercial scale to support growing client demand.

This expansion will enhance Almac’s existing early phase biomarker development capabilities through to assay development and deployment in clinical trials, cementing the company’s position in the market as a fully resourced partner of choice to pharma companies for manufacturing and commercialisation of companion diagnostics.

Alan Armstrong, Chief Executive of Almac Group said: “Almac is committed to re-investing all our profit back into the business.

“This £80 million expansion and the creation of 550 new, highly skilled jobs in Northern Ireland will ensure 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.”

These projects have been supported by Invest Northern Ireland who have welcomed the development and ongoing expansion of the Almac Group.

Jeremy Fitch, Executive Director of Business Growth Group, Invest Northern Ireland said: “Almac’s commitment to innovation and excellence has positioned it as a cornerstone of our region’s Life & Health Sciences success story and supported it to build a world-renowned reputation for ground-breaking work in the global pharmaceutical industry.

“We are delighted to support this investment which is creating hundreds of employment opportunities in the Armagh, Banbridge and Craigavon Borough Council area and will bolster Northern Ireland’s reputation as a hub for pharma and diagnostic development. We commend Almac’s dedication and vision and we look forward to witnessing the positive impact this investment will have on Northern Ireland’s economy and the advancement of life changing medicines.”

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Almac Pharma Services Hosts Recruitment Open Day in Loughborough

amoreland — Fri, 12 May 2023 13:18:27 +0000

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, is actively recruiting to fill 30 new analytical roles over the next year, over half of which are live right now, with more to follow based at its Charnwood Campus in Loughborough.

As part of this recruitment, Almac is hosting two open day sessions on Wednesday 24^th May where interested candidates can tour the Charnwood facilities and find out more about the company, available roles and the wide range of career opportunities available.

A number of Almac’s analytical staff will be on hand to talk about their experiences of working at the global organisation. There will also be one-to-one sessions with Almac’s hiring teams to discuss CVs, learn more about individual roles and potential fast-track to interview. Registration to attend is now open here.

The expert team at Almac’s Charnwood facility partners with global pharmaceutical and biotech companies to provide tailored drug development, manufacturing and analytical solutions for a range of therapy areas including oncology, infectious disease and respiratory.

Trevor Clarke, Vice President of Analytical Operations, Almac Pharma Services, said: “Almac is experiencing significant growth and filling these roles will bolster our ability to continue to support our many clients across the globe.

“We are looking for talented analytical staff at all levels who can apply their current skills, expertise and ideas. You will play an essential role in helping us to achieve our goal of advancing human health, meaning you will make a real difference to patients in need.

“A career at Almac provides you with an excellent opportunity to join an established, global company where we are committed to your career success.

“If you are looking for a new challenge in a growing, progressive company, we want to hear from you!”

Jane Hunt, Member of Parliament for Loughborough has welcomed news of additional new job opportunities locally with Almac. She commented: “I am delighted at Almac’s success to date and excited at their level of ambition for growth.

“It is great to see highly skilled job opportunities being made available and I wish the company well in this latest recruitment drive. I look forward to seeing the company further expand and wish them continued success.”

Almac’s Charnwood facility has been a true success story since its acquisition in 2015, growing from a core staff of 70 people, the company now employs over 250 individuals and continues to increase its capacity and capabilities to meet increasing client demand for its innovative drug development services.

For more information on roles and recruitment within Almac Pharma Services, visit here.

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Technical Quality Team Leaders Graduate with Masters in Pharmaceutical Validation Technology

admin — Fri, 24 Mar 2023 13:52:00 +0000

Three members from Almac Group’s Pharma Services’ Technical Quality team, Emma Kelly, Jason Wilson and Darryl McConnell recently graduated from Technological University Dublin with a Masters of Science in Pharmaceutical Validation Technology.

The graduates began the intensive course in January 2020 and completed it earlier this year. It has expanded their advanced technical knowledge and in turn benefitted the teams they lead.

The Technical Quality team has been focused on developing employee knowledge through a range of qualifications and CPD modules with the ultimate goal of enhancing client delivery. This has been endorsed by the Executive and Senior Management teams, particularly Trevor Clarke, VP Analytical Operations.

Trevor Clarke said: “Almac Pharma Services is committed to investing in the continual training and upskilling of our employees. Providing support from placement students through to Master’s degrees ensures that we continue to carve a pathway to develop and grow knowledge in a productive and beneficial way.

Courses in validation are not widely available which makes these MSc credentials an important asset to the knowledge we provide to our clients. We previously shared the news that a number of the Technical Quality team had completed CPD modules in validation. The successful completion of this course helps to build on the knowledge and experience that has already been developed.

Throughout the MSc, Emma, Darryl, and Jason, who are all line managers were supported to focus on their studies during semesters. They all demonstrated immense dedication to complete the remainder of their course workload during evenings and weekends, largely during the pandemic.

The knowledge gained by everyone is evident at cross-functional internal business meetings, client and vendor calls, audit support and in the direction given to their respective teams on validation strategy, execution, and overall compliance.

Knowledge sharing is key and each of the team leaders regularly share materials and learnings with their teams and support employees who are undertaking CPD Modules from the same course.

Congratulations to Emma, Darryl, and Jason on their significant achievement.”

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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

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Almac Pharma Services Announces Two Vice President Appointments

admin — Mon, 23 Jan 2023 16:53:00 +0000

Craigavon, Northern Ireland – 23 January 2023 – Almac Pharma Services, a member of the Almac

Group providing innovative pharmaceutical development, manufacture and commercial services, has announced the appointment of two new Vice Presidents. Both will serve on the Almac Pharma Services’ Executive Leadership Team, reporting directly to John McQuaid, President & Managing Director of Almac Pharma Services.

Trevor Clarke has been appointed to the position of Vice President, Analytical Operations, Pharma Services.

Harry Lindenmuth has been appointed to the position of Vice President, Operations Audubon, Pharma Services.

John said: “It gives me great pleasure to announce these two appointments.

“Trevor has been a key member of the team since he joined as a Quality Manager in 2005. He has held various site and global quality leadership roles and has been influential in supporting growth and service expansion of the business. This appointment to the Almac Pharma Services’ Executive team underlines the importance placed on Analytical Operations which underpins so many of the services we deliver to our clients.”

“Harry joined Almac as Audubon Site Director in June 2020. He has been influential in the strong performance of the Pennsylvanian based site with delivery metrics resulting in positive client sentiment and leaving the site well poised for further growth.”

“I look forward to their contribution to our continued success.”

#ENDS#

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.

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 6,600 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.

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Almac Pharma Services Recruiting Senior Operators in Charnwood

davidkane — Thu, 12 Jan 2023 15:16:07 +0000

Loughborough, UK – 11 January 2023 – Almac Pharma Services, the global pharmaceutical contract development and manufacturing organisation is recruiting a number of Senior GMP Operators within its Pharmaceutical Manufacturing team at its Charnwood site in Loughborough.

No previous experience is required to join the company at Senior GMP Operator Grade 1 level as full training will be provided, allowing candidates to progress through the Senior Operator grades as their skills develop. Almac also offers opportunities for experienced professionals.

The successful candidates will be supported by Senior Operators and the Operations Management team through a mentoring and training programme, to identify how best to put their unique skills to use. The programme aims to enhance the trainee Operators’ capabilities and assist them to truly shine in their career at Almac whilst making a significant contribution to patient health worldwide.

An open day will be held at 6pm on Wednesday 18^th January, 2023 at Almac’s production facility, in the Charnwood Campus, Woodhouse Building on Bakewell Road in Loughborough. Prospective applicants will have the opportunity to hear more about the roles and tour Almac’s facility. HR representatives will also be on hand to provide advice on completing the application form, and to discuss the benefits included in the programme.

James Hurst, VP of Operations and Charnwood Site Head, said: “At Almac, we are passionate about mentoring our employees to highlight the possibilities that come with their skillset and develop those skills to unlock their potential, career progression and growth. We look forward to welcoming new colleagues to help us advance human health together.”

Jane Hunt, Loughborough MP, said “I am very proud that Almac is based in Loughborough, it is a prestigious company to have at our Charnwood Campus site. The recruitment drive will offer new opportunities to local residents and graduates alike and will give employees the ability to gain new skills and move up the career ladder. Please do go along to the event and find out more.”

Hasan Girach, Senior Operator, Grade 2 said, “As a physics graduate with no experience in the pharmaceutical industry, joining Almac was initially a daunting prospect. However, working alongside skilled operators with a vast array of knowledge, in a fast-paced environment guaranteed new learning opportunities on a daily basis.

“Being trusted to lead projects and operate often complex equipment allowed me to build my confidence, quickly progress in my role and set off my career in the pharmaceutical industry”

Kieran Gillman, Senior Operator Grade 1 said: “I joined Almac without any Pharmaceutical experience. Today I am leading projects, operating complex machines and passing down my knowledge to new employees.

“Almac has given me opportunities I never thought I’d be given and has boosted my confidence and broadened my scope within the industry.”

For details on the information session, please visit: https://www.almacgroup.com/careers/almac-charnwood-operator-career-open-day/

ENDS

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

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.

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Almac Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv)

davidkane — Tue, 13 Dec 2022 15:00:00 +0000

First and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and paediatric patients aged eight years and older with Stage 2 T1D

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has successfully supported the packaging and rapid launch of Provention Bio Inc’s product, TZIELD™ (teplizumab-mzwv) into the US market.

TZIELD* was approved on 17^th November by the United States Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening.

T1D is an autoimmune disease that occurs when the immune system attacks and destroys the cells that make insulin. People with Stage 3 T1D have increased glucose levels, eventually requiring insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, T1D is usually diagnosed in children and young adults.

The Almac Pharma Services’ Pennsylvanian based team began its partnership with Provention Bio, Inc. to support the packaging of the TZIELD product for commercial supply in 2020. Together they agreed on an appropriate strategic programme to efficiently, and effectively, prepare the specialised treatment for distribution including expediting all aspects of packaging and labelling to distribute TZIELD to patients within weeks of FDA approval.

“At Provention, we look to our manufacturing and operational partners for their strong industry expertise, infrastructure and compliance to regulatory standards to help execute a successful commercial launch,” noted Christina Yi, Chief Operations Officer at Provention Bio. “That’s why we partnered with Almac – our operational partnership supports TZIELD reaching patients across the US and helps us accelerate the depth and breadth of its launch.”

Harry Lindenmuth, Audubon Site Director, Almac Pharma Services commented: “We are pleased to have supported the launch of Provention Bio, Inc.’s first biologic treatment. Our team is delighted to have played a role in packaging this key advancement in delaying the onset of stage 3 type 1 diabetes. Through our relationship with Provention Bio, Inc., the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, protecting the integrity of TZIELD whilst ensuring it was delivered shortly after FDA approval. Many congratulations to our partners at Provention Bio, Inc. on the development of this treatment.”

Almac Pharma Service’s commitment to partnering to advance human health is most visible through key partnerships with companies such as Provention Bio, Inc., who are working to advance life-changing treatments and therapies to patients.

*TZIELD may cause serious side effects, including Cytokine Release Syndrome and a decrease in white blood cells. Please see Important Safety Information http://bit.ly/3VgvSjX and Medication Guide and Prescribing Information http://bit.ly/3hZZiEK.

#ENDS#

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company’s pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

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 Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv) appeared first on Almac.

Almac Pharma Services Supports Packaging and Supply of PTC Therapeutics’ Gene Therapy Upstaza™ for EU Launch

davidkane — Mon, 17 Oct 2022 13:00:00 +0000

Tailored ultra-low temperature solutions enabled first and only approved disease-modifying treatment for AADC deficiency to be approved by EMA

Craigavon, Northern Ireland – 17 October 2022 – Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has successfully supported the packaging and commercial supply of PTC Therapeutics, Inc.’s gene therapy product, Upstaza™ (eladocagene exuparvovec).

Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy infused directly into the brain. The product is approved for patients 18 months and older and marketing authorisation is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.

Almac Pharma Services began their partnership with PTC to support the Upstaza product introduction in 2019 through its innovative and tailored ultra-low temperature (ULT) solutions. The Almac team, located in Europe, worked directly with PTC to establish a deep understanding of the unique treatment, and every aspect of the special conditions required to handle, store and process the gene therapy product.

Together they agreed an appropriate strategic programme to efficiently, and effectively, prepare the specialised treatment including packaging, labelling and serialisation over dry ice to guarantee product integrity throughout.

“We are proud to partner with Almac to support packaging and supply of Upstaza for people living with AADC deficiency in Europe,” said Kylie O’Keefe, Senior Vice President, Head of Global Commercial and Corporate Strategy, PTC Therapeutics. “We look forward to continuing our partnership with Almac to bring the best innovation from PTC to the people living with rare diseases who are counting on us.”

Grainne Hughes, VP Business Support Operations, Almac Pharma Services commented: “We are delighted to have supported the rapid launch of this ground-breaking gene therapy product which has been marked as a pivotal milestone for AADC deficiency patients. Our ULT specialists understand that each product is unique in its requirements to guarantee its integrity throughout the entire process. Through our established relationship with PTC, the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, underpinned by Quality Risk Management, to protect the integrity of Upstaza whilst ensuring it was delivered on time. Many congratulations to our partners at PTC on this fantastic achievement.”

In March 2022, Almac announced the expansion of its dedicated Centre of Excellence and offers an expansive storage facility with specialist suites and freezer capacity to enable inventory stock of crucial product supply ready for rapid distribution when required. The CDMO currently provides solutions for over 25% of EU approved/pre-registration advanced therapeutic medicinal products (ATMPs) having processed and QP released over 700 batches to date.

#ENDS#

About PTC Therapeutics, Inc.

PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC’s mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC’s strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and Twitter at @PTCBio.

About Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

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 Pharma Services Supports Packaging and Supply of PTC Therapeutics’ Gene Therapy Upstaza™ for EU Launch appeared first on Almac.

Almac Group Announces New COO and Appoints New Almac Pharma Services MD

davidkane — Tue, 04 Oct 2022 07:00:00 +0000

The Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of Graeme McBurney to the Board of Directors in the role of Chief Operating Officer effective 1st October 2022.

Graeme has over 30 years’ experience in the pharmaceutical industry. He joined the Almac Group in 1990 and has held a number of operational and management positions, most recently as Managing Director and President of Almac Pharma Services since 2003.

In his new role, Graeme will be responsible for implementing operations aligned with long term business goals and the Group’s strategies. He will oversee operations of the Group and work with Almac Executives to secure the functionality of the business to drive continued growth.

Almac has also announced today that John McQuaid will succeed Graeme as Managing Director and President of Almac Pharma Services, which provides a range of pharmaceutical development, manufacture and commercial services. John will now be responsible for overall strategic, operational and financial leadership of the Almac Pharma Services business.

John has been with Almac since 1994 and has held a number of management roles including project management, production and quality. He was appointed Vice President of Technical Operations in 2011 where he was responsible for overseeing the strategic growth and development of the Pharmaceutical Development service offering within Almac Pharma Services.

Alan Armstrong, CEO Almac Group, said: “We are delighted to welcome Graeme to the Board at this exciting time as we progress our global growth strategy. His wealth of experience and expertise will be instrumental in supporting our vision and congratulations to John on his new role as he leads Almac Pharma Services.”

Graeme commented: “I am honoured to join the Almac Group Board of Directors and look forward to the next phase of Almac’s evolution as we remain focused on our client relationships and the continued strategic growth of the Group. I also congratulate John on his promotion to MD of Almac Pharma Services. Having worked alongside John for many years, I am confident his technical knowledge and expertise coupled with strategic management experience is the perfect blend to lead and evolve the business.”

This announcement comes just months after the Group announced a £200m global expansion having recorded a £58m (8.6%) rise in turnover from £677m in 2020 to £735m in 2021 and a 5.8% increase in the Group’s average employee figures from 5,466 to 5,783 from October 2020 to September 2021.

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 Almac Pharma Services

Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, commercial drug product manufacture, commercial packaging through to global storage & distribution.

The post Almac Group Announces New COO and Appoints New Almac Pharma Services MD appeared first on Almac.

Almac Group Recognised in Life Science Leader CMO Awards for the Eighth Time

allie — Tue, 01 Feb 2022 08:00:00 +0000

Almac Pharma Services, a member of the Almac Group, has been named as a winner of the CMO Leadership Awards for the eighth time. The global contract manufacturing and development organisation which offers a comprehensive range of tailored solutions from pharmaceutical development to commercial services were named as a top performer in both the Quality and Compatibility categories.

The CMO Leadership Awards recognises top performing CMOs, celebrating outstanding companies in drug development and manufacturing emphasising high standards of quality, integrity and innovation exemplified in their work. Almac Pharma Services received two awards based on its global reputation for excellence built over 50 years of client service across the drug development and commercialisation lifecycle.

Industry Standard Research Contract Manufacturing Quality Benchmarking research is conducted annually via an online survey and winning CMOs are chosen based on impartial feedback from sponsor companies that utilise outsourcing services. For the 2022 CMO Leadership Awards almost 90 contract manufacturers were evaluated on 23 performance metrics. CMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Graeme McBurney, President and Managing Director, Almac Pharma Services, commented: “I am delighted that Almac Pharma Services has been recognised by the prestigious CMO Leadership Awards once again. It is especially poignant at a time when we have all faced unprecedented challenges brought about as a result the COVID-19 pandemic. Winning this award in both the Quality and Compatibility categories is testament to the continued efforts of our global team to ensure we deliver best-in-class, tailored and timely solutions to our clients, and their patients”

The CMO Leadership Awards offers accurate and reliable customer feedback to provide support in choosing a reputable partner for development and manufacturing needs within the biopharmaceutical and pharmaceutical industry.

“Congratulations to all the Life Science Leader and Outsourced Pharma 2022 CMO Leadership Award winners. You are the biopharma industry’s top service providers – those who have exceled for your customers through pandemic hurdles, supply-chain challenges, and advancing demands of new platforms and technologies. An award in any category – capabilities, compatibility, expertise, quality, reliability and service – is one recognized throughout the industry,” added Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma.

About Almac Group

A unique culture delivering exceptional solutions

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, 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 19 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 the CMO Leadership Awards

Now in its 11th year, Outsourced Pharma and Life Science Leader’s CMO Leadership Awards provide readers with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs. For the 2022 CMO Leadership Awards, Industry Standard Research determined the award recipients through their evaluation of more than 86 contract manufacturers. These CMOs were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. For more information about the awards, visit the awards website.

The post Almac Group Recognised in Life Science Leader CMO Awards for the Eighth Time appeared first on Almac.

Almac Group’s Charnwood Site Achieves Globally Recognised Health & Safety and Environmental Management System Certifications

allie — Tue, 06 Jul 2021 06:55:00 +0000

Craigavon, UK, 6 July 2021 – Almac Group, the contract development and manufacturing organisation, is pleased to announce that the organisation’s Charnwood site (Loughborough, England) has been certified to the International Organisation for Standardization (ISO) standards 45001 and 14001, following a United Kingdom Accreditation Service (UKAS) accredited audit of the site’s Integrated Management System (IMS).

ISO is an independent, non-governmental, international organisation that produces international standards to support innovation and provide solutions to global challenges. Almac’s recent UKAS certifications in Charnwood were to ISO 45001 and 14001, globally recognised standards for Operational Health & Safety and Environmental Management, respectively.

Almac expanded to the Charnwood site in Loughborough in 2015, in direct response to client demand. The site is a complement to the company’s existing pharmaceutical drug product development services at the company’s global headquarter campus in Craigavon, Northern Ireland, which has been certified with Health & Safety and Environmental standards for over a decade. The facilities at Charnwood have significant capacity to support tailored GMP formulation development and manufacturing of solid oral dosage forms for clinical and small-scale commercial needs, in addition to housing over 1,500m² of readily available, customisable GMP floor space.

James Hurst, VP Operations & Charnwood Site Head, commented: “As an organisation, Almac takes our commitment to corporate social responsibility seriously. We are therefore delighted that the results of the UKAS audit certify that we meet the high ISO standard of Health & Safety and Environmental Management, a significant achievement in demonstrating that our Charnwood site is a safe, sustainable and responsible place for our global partners to conduct their projects. We look forward to further growth at the site.”

The integrated framework gives all managers and employees guidance and support regarding the management of HSE, from identifying and handling risks to evaluating and continuously improving processes and is continually updated and improved through regular assessments, reviews and internal audits. The certification of the Charnwood campus marks the start of Almac’s overall strategy to roll out the ISO 45001 and ISO 14001 certification throughout multiple sites across the globe in the coming years.

The post Almac Group’s Charnwood Site Achieves Globally Recognised Health & Safety and Environmental Management System Certifications appeared first on Almac.

Almac Pharma Services Launches Trainee Recruitment Drive

kelly — Wed, 16 Jun 2021 14:24:49 +0000

Craigavon, UK, 16 Jun 2021 – Almac Pharma Services, a member of established global contract development and manufacturing organisation Almac Group, is recruiting up to ten new Trainee roles within its Packaging Operations team at the company’s global headquarters in Craigavon.

The new Trainee Production Operative roles will be 1-year fixed term contracts with potential to become permanent members of the Almac team and progress towards Grade 2 Senior Operator status. Beyond this, opportunities exist to progress to Grade 3 Senior Operator, Production Technician and Supervisor roles.

There is further potential to transfer skills and explore other support roles within Almac Pharma Services, for example in Quality, Validation or Production Support.

The roles in question are suitable to those who are qualified to A-Level (or an equivalent level 3 standard qualification), including those expecting to receive grades in August. The company is particularly interested to hear from candidates who have studied Life and Health Sciences (or other STEM subjects) and BTEC Applied Science. Candidates who are mechanically minded or are proficient in the use of computer software and touchscreen applications will also be of interest.

Mentorship and full training will be provided by Senior Operators and the Operations Management team. Successful candidates will be guided to find aspects of the role where their unique skills can be put to use, enhancing their capabilities and assisting them to truly shine in their career.

With over 30 years’ experience in the development and manufacture of medicinal products, the capabilities of Almac Pharma Services include formulation and analytical development, clinical and commercial-scale drug product manufacture, primary and secondary packaging and global supply chain management.

Mark English, VP Packaging & Logistics at Almac Pharma Services, said, “The Institute for Fiscal Studies reported that young workers today would be hit hardest by the pandemic with regards to unemployment and job prospects. We are pleased, particularly in the current climate, to be recruiting for STEM roles that would be suited to school leavers or young adults who are qualified with relevant A-Levels or BTECs.

“At Almac, we are passionate about mentoring our junior employees to highlight the possibilities that come with their skillset and developing those skills to unlock potential progression and growth. We look forward to welcoming our new colleagues to help us advance human health together.”

For information on the opportunities available, including job specification and to make an application ahead of the deadline on 9 July, please visit Almac Group Careers website.

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 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.

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

The post Almac Pharma Services Launches Trainee Recruitment Drive appeared first on Almac.

Almac Pharma Services Achieves Unprecedented Global Regulatory Milestone

admin — Wed, 25 Sep 2019 07:00:03 +0000

Three successful regulatory inspections completed in two weeks

Craigavon, U.K., 24 Sep 2019 – Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.

The UK MHRA conducted a routine GMP audit at the company’s Charnwood, UK facility. The 230,000ft² site, based in Loughborough, was acquired by Almac in 2015 and provides GMP development and manufacturing of solid oral dose clinical trial materials and small scale commercial volumes. The three day inspection of the site’s quality systems resulted in no critical or major findings.

Meanwhile, the company’s global HQ site in Craigavon, Northern Ireland was received a general GMP inspection by the US FDA. Operations carried out at this site include GMP and non-GMP pharmaceutical development, commercial scale manufacturing and packaging of solid oral dose material, secondary labelling, serialisation and distribution of drug product globally. The inspection was also successful with no 483 issued.

Finally, the US FDA performed an unannounced inspection at the company’s Audubon, PA, USA facility which provides a range of specialised commercial packaging services including complex kit assembly for medical devices, combination products and biologic packs. The inspection covered general aspects of GMP and the company’s operations with biologic products and, again, closed with no 483 being issued.

Ian Markwell is the VP of Quality and has overall responsibility for the company’s global regulatory compliance. He said: “It is unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time. It is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome.”

With over 50 years’ experience and a wealth of expertise providing flexible, quality-led pharmaceutical solutions Almac was pleased to achieve complete success across all three sites confirming that no critical or major observations were raised throughout.

Responding to the news, Graeme McBurney, Managing Director & President, Almac Pharma Services commented “We recognise that quality determines the extent of our success and therefore place a high priority on ensuring our company-wide quality systems not only meet, but exceed, global regulatory standards. Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organisation.

“We are dedicated to investing further in our innovative systems thereby ensuring our clients continue to receive superior services enabling them to bring important new treatment to patients throughout the world.”

###

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 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Click here to view our facilities.

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 Pharma Services Achieves Unprecedented Global Regulatory Milestone appeared first on Almac.

Almac Group Recognised with Six Life Science Leader CMO Awards

admin — Tue, 26 Mar 2019 08:00:59 +0000

Craigavon, N.I., 26 March 2019 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won awards in all core categories for 2019 for excellence in Quality, Reliability, Capabilities, Expertise, Compatibility, and Service.

These awards recognise Almac’s global reputation for excellence built over 50 years of client service across the drug development and commercialisation lifecycle and is the organisation’s seventh consecutive year of winning the awards.

The CMO Leadership Awards recognise top performing CMOs, celebrating outstanding companies in drug development and manufacturing, emphasising high standards of quality, integrity and innovation exemplified in their work. The winners were revealed at a ceremony on 20^th March at Convene at 237 Park Avenue, New York.

ISR’s Contract Manufacturing Quality Benchmarking research is conducted annually via an online survey. For the 2019 CMO Leadership Awards more than 120 contract manufacturers were evaluated on 23 performance metrics. CMOs must meet the minimum threshold of customer survey responses to be eligible for an award.

Graeme McBurney, President and Managing Director, Almac Pharma Services, commented: “I am both delighted and proud that Almac has been consistently recognised by Life Science Leader at the annual CMO awards. Receiving recognition in all six categories reflects our continued efforts to provide best-in-class services to our global client base and these accreditations are especially meaningful as we have been evaluated by customers we have actually worked with.”

The CMO Leadership Awards are an opportunity to showcase companies with outstanding reliability and service capabilities impacting client’s complete drug development lifecycle.

“The value and importance of the Life Science Leader CMO Awards grows each year. No industry awards are more meaningful than these recognizing the highest level of accomplishment as evaluated by actual customers. An award in any of the categories assessed, including capabilities, compatibility, expertise, quality, reliability and service, adds a clear acknowledgement of the leadership provided by the CMO recipient. Our congratulations to all of this year’s CMO Award winners — you keep the industry on the path to further success.” says Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma.

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

About Almac Group

A unique culture delivering exceptional solutions

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, 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 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

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

The post Almac Group Recognised with Six Life Science Leader CMO Awards appeared first on Almac.

Almac Group Announces Successful HPRA Inspection at its European Campus

admin — Tue, 02 Oct 2018 06:55:02 +0000

Craigavon, N.I., UK, 02 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce the successful inspection of Almac Pharma Services (Ireland) at its European campus in Dundalk, Ireland, by the Health Products Regulatory Authority (HPRA).

Almac Group previously confirmed that the premises secured in Dundalk as part of its ongoing global expansion strategy were successfully inspected by the HPRA in January 2018. This initial inspection provided Almac with the regulatory approvals to conduct QP certification of both clinical and commercial drug product from its European campus in Dundalk.

Since January, Almac has made an investment of £10 million to establish state-of-the-art analytical laboratories and commercial packaging suites to ensure current and future client needs within the European Union are met.

This recent inspection by the HPRA now enables Almac Pharma Services to support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions for a wide range of finished pack presentations. Ian Markwell, VP of Quality, commented “We are extremely pleased with this inspection outcome. Not only does this illustrate the strength of our Global Quality Management System but provides assurance to our client partners that we meet all EU regulatory requirements.”

Graeme McBurney, Managing Director, Almac Pharma Services, commented: “This is a great achievement and reflects Almac’s commitment to provide our global client partners with an uninterrupted service provision and seamless access to the EU marketplace. Regardless of the outcome of Brexit negotiations, we look forward to providing best in class, bespoke packaging solutions, from this new European facility.”

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 Announces Successful HPRA Inspection at its European Campus appeared first on Almac.

Almac Group Appoints New Site Head for Charnwood Campus, Loughborough, UK

admin — Mon, 27 Aug 2018 06:55:36 +0000

Craigavon, N.I., UK, 27 Aug 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of a new Site Head for its Charnwood campus, in Loughborough, UK.

James Hurst, who joined Almac Pharma Services in 2008 as Analytical Manager, and in most recent years was Head of Pharmaceutical Development Operations at Almac’s global HQ site in Craigavon, has this year taken up the role of Site Head at the company’s new manufacturing and analytical facilities at the Charnwood Campus in Loughborough, UK.

Together with the Pharma Services’ Senior Management team, James will set the strategic direction of the site and will have responsibility for its operational management and performance.

James is a graduate of the Manchester Metropolitan University and holds a Bsc (Hons) in Chemistry.

John McQuaid, Vice-President Technical Operations of Almac Pharma Services commented “We are delighted that James has taken the position of Site Head at our Charnwood campus. James was key to the successful growth of our pharmaceutical development service offering at Craigavon and we look forward to him using this experience to drive the growth of operations at Charnwood as we increase capacity to support our global client base.”

###

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 almost 50 years and now employs close to 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Europe, 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 Appoints New Site Head for Charnwood Campus, Loughborough, UK appeared first on Almac.

Almac Group Appoints Three Vice Presidents

admin — Wed, 25 Jul 2018 07:00:28 +0000

Craigavon, N.I., 25 July 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced the appointment of three new Vice Presidents within its Pharma Services Business Unit as it expands its executive team.

Jonas Mortensen is appointed to the position of Vice President of Business Development. Bringing extensive experience to the role, Jonas is responsible for leading the global Business Development, Proposal and Marketing teams. Jonas is a graduate of the University of Copenhagen with a Masters in Biology. He started his career in discovery research as a scientist and project management before progressing into quality management for a Scandinavian pharmaceutical products company and until recently, worked in Business Development for a leading CDMO.

Grainne Hughes, who joined Almac Pharma Services in 1999 and in most recent years held the position of Head of Operations, was promoted to Vice President of Business Support Operations. Grainne will lead all support functions across the business including Client Services, Planning, Business Systems and Business Projects. Grainne graduated from Queen’s University Belfast with a BSc in Biomedical Sciences and also obtained an MSc in Manufacturing Management from Ulster University.

In a similar move, Mark English, who joined Almac Pharma Services in 2010 as Distribution Manager and in most recent years was Head of Logistics, has now been promoted to the position of Vice President of Packaging & Logistics Operations. In this role, Mark will have responsibility for all packaging and logistic operations across Almac Pharma Services’ global commercial facilities in the UK, Ireland and USA. Mark is a graduate of the University of Edinburgh and holds a BEng in Chemical Engineering.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “We are delighted to welcome Jonas, Grainne and Mark to their new positions at Almac Pharma Services. They each bring a wealth of experience and impressive track records in their various roles. We look forward to their contribution to the delivery and success of our future expansion plans.”

###

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 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 Appoints Three Vice Presidents appeared first on Almac.

Almac Group Expands US Specialised Commercial Packaging Capabilities

admin — Mon, 16 Apr 2018 13:00:57 +0000

Audubon, PA, 16 April 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce that it has expanded its US commercial packaging capabilities at its Audubon, PA facility.

Addressing increased client demand of developing and bringing more advanced medicines and niche orphan drugs to market, Almac Pharma Services has enhanced its offering by adding bespoke technology for the specialised packaging of complex kit assembly for medical devices, combination products and biologic packs.

The innovative semi-automated packaging system (SAPS) was tailor designed, built and installed by Almac’s in-house engineering team providing a best-in-class packaging solution for medical device kits and parenteral delivery forms.

The SAPS line provides a streamlined and efficient semi-automated process for the packaging of complex medical kit components and can process both standard and custom syringes, as well as auto-injector pens and any other medical devices. The highly customisable technology can operate to various scales, allowing for a variety of pack formats from sample kits to marketing packs in addition to multi-product dosage packaging.

Ensuring quality is guaranteed throughout the process, the specialised packaging line has multiple state of the art vision systems providing 100% automated verification and rejection of all components, ensuring variable data correctness, full colour recognition and medical kit completeness.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “Almac continues to invest in, and expand upon, our US commercial packaging capabilities. The introduction of this specialised technology not only enhances our existing US commercial labelling and packaging capabilities, but provides an efficient and cost effective semi-automated packaging solution to meet the evolving packaging needs of our client partners.”

To find out more visit the Almac booth #524 at this year’s CPhI North America in Philadelphia from 24th April.

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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 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 Expands US Specialised Commercial Packaging Capabilities appeared first on Almac.

Almac Group Announces Successful MHRA Inspection at Charnwood Facilities

admin — Mon, 23 Oct 2017 07:30:10 +0000

Craigavon, N.I., UK, 23 October 2017 – Almac Group, the Craigavon-based global contract pharmaceutical development and manufacturing organisation, is pleased to announce the successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its new Pharmaceutical Development & Manufacturing facilities at Charnwood Campus, Loughborough.

In November 2015, to meet ongoing client demand, Almac Group announced the expansion of its pharmaceutical development & manufacturing services with the acquisition of a significant proportion of the 70-acre Charnwood Campus in Loughborough, England – a world-class science, technology and enterprise park. Since that announcement the facilities have undergone significant investment both in building enhancements and the installation and validation of new processing and analytical technology.

This successful MHRA inspection provides Almac Pharma Services with the necessary licenses to develop, manufacture and pack non-potent and potent, solid oral drug products for clinical trials and commercial supply at the Charnwood site, with the new facility complementing the existing development & GMP services offered from the company’s Craigavon NI Headquarters.

Trevor Clarke, Global Head of Quality Systems commented, “We are extremely pleased with the successful roll-out of our Global Quality Management System to the new Charnwood site. This positive endorsement by the MHRA provides our clients with increased capacity governed by the same pharmaceutical quality system which they are already familiar with at our existing sites in Craigavon, Northern Ireland and Audubon, Pennsylvania.”

Graeme McBurney, Managing Director, Almac Pharma Services commented: “This is a great achievement and positive reflection of both the investment Almac has made in the site and of our staff operating the facilities. We are looking forward to beginning work for our clients at these world class facilities and already have committed projects which will commence in the coming months.”

Ends

About Almac Group
‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over almost 50 years and now employs in excess of 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 or visit almacgroup.com

The post Almac Group Announces Successful MHRA Inspection at Charnwood Facilities appeared first on Almac.

Almac Group Expands Commercial Capabilities to Meet Industry Demand for Paediatric Formulations

admin — Mon, 14 Nov 2016 13:56:08 +0000

Craigavon, N.I., UK, – Date 14 November 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce that it has expanded its MHRA/FDA approved UK commercial packaging facility with the acquisition of a stick sachet packaging line from Merz.

The acquisition comes in response to growing demand for the specialist packaging solutions for paediatric drug products, specifically powders, minitabs or granules into stickpack sachets. This investment was made in partnership with a long-term commercial US client who having worked with Almac since 2010, now sought an integrated commercial manufacturing and packaging solution for the EU supply of their new paediatric formulation drug product.

In line with EU Paediatric Regulations (EC1901/2006 and EC1902/2006), the US client implemented its Paediatric Investigation Plan (PIP) and developed and launched an age appropriate formulation to meet infant patient needs; with Almac manufacturing the paediatric granules, primary packing into stickpack sachets and then into wallet cards.

To facilitate the packaging of paediatric dosage forms, investment was made in Merz Stickpack technology. The SBL-50 stickpack technology is a fully automated forming, filling and sealing machine capable of filling 80 stickpacks / minute. This flexible technology not only meets the stickpack presentation needs of Almac’s current clients but has capacity to process new paediatric drug products (powders, granules and minitabs) that require this specialist packaging.

David Downey, VP Commercial Operations at Almac commented “Almac continue to expand our commercial packaging capabilities and the addition of this stickpack solution strengthens Almac’s position in providing flexible services to meet various market needs from small volume orphan drug products to large scale marketed products in both adult and paediatric forms.”

Holger Merz, General Manager at Merz said: “The innovative and committed team at Almac set up a compact, highly flexible packaging solution for micro tablets and powders in stickpacks to service the growing demand for this user-friendly dosage form. Advanced primary packaging forms like stickpacks offer highest flexibility for diversification of pharmaceutical products.”

About Almac’s Commercial Services

With over 40 years’ experience and commercial facilities in the UK and US, our global reach and local expertise provides flexible, quality led commercial solutions.

Providing commercial services for new product launches or transferring existing commercial products, we specialise in the scalable manufacture and packaging of solid oral dosage forms from niche orphan drugs to high volume marketed products. Complimented by tailored packaging solutions for sterile, sachet and blister presentations we have supported the launch of multiple orphan drug products over the last 3 years. Value added solutions in artwork/pack design, QP release and 3rd Party Logistics provides end-to-end commercial solutions for our client partners.

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).

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

About Merz

For more than 40 years, the company MERZ Verpackungsmaschinen GmbH has been developing and manufacturing stickpack-machines, 3-and 4-side sealing bag machines, innovative dosing technology as well as tailored packaging equipment. MERZ packaging machines are in use in more than 40 countries all over the world!

A significant advantage for our customers is the supply of complete “turn-key” lines with 1 to 5 lanes, including end of the line packaging into folded cartons or into cardboard boxes.

The family owned company is the place for personal, customized packaging solutions and special machineries.

For more information, please visit www.merz-system.de or e-mail to mail@merz-system.de

The post Almac Group Expands Commercial Capabilities to Meet Industry Demand for Paediatric Formulations appeared first on Almac.

Almac Group announces significant expansion in pharmaceutical development capacity

admin — Mon, 09 Nov 2015 08:36:27 +0000

Craigavon, N.I., UK, – 09 November 2015 – Almac Group, the global contract development and manufacturing organisation, has confirmed a £16 million investment to expand its formulation and analytical development services to meet ongoing client demand.

The company announced the successful conclusion to negotiations to operate a significant proportion of the 70-acre Charnwood Campus in Loughborough, England – a world-class science, technology and enterprise park. Specifically, Almac will occupy the formulation development and analytical testing facilities at the site which will complement existing development & GMP services offered from its Craigavon NI Headquarters.

The Charnwood facilities were originally designed and built by a global Pharma company as part of its in-house formulation development, clinical manufacturing & analytical testing capabilities. Almac has now commenced recommissioning of the facilities with operations focusing initially on expanding both non-potent and potent solid oral dose processing, creating approximately 180 new jobs in the next 5 years. With an initial investment into the Charnwood site of ~£16m in process and analytical technologies, an operational start date is targeted for Q1 2017.

Graeme McBurney, Managing Director, Almac Pharma Services commented: “As we experience increased client demand for our pharmaceutical development and niche commercial manufacturing services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and capability and further demonstrating our continued commitment to support our global clients in the development and manufacturing of their drug products.”

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

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Almac invests to accelerate formulation development services

admin — Wed, 23 Oct 2013 09:09:11 +0000

In Jan 2013, Almac completed the doubling of their pharmaceutical development service capabilities with the opening of a new dedicated Non-GMP facility together with 2 analytical laboratories at their UK headquarters.

Although the new facility is dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

In parallel to the new non-GMP facility, Almac has doubled its analytical capacity with new analytical laboratories for processing the large sample sets which result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of QbD.

Additionally, in response to increased client demand for preclinical and early phase clinical GMP supply, Almac have further enhanced their pharmaceutical development offering with an investment in additional Xcelodose® technology. Similar to our existing Xcelodose technology this additional Xcelodose unit comes complete with an Xcelohood providing the capability to dose potent API directly into capsules.

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times. The investments this year in the new non-GMP facility and Xcelodose equipment strengthens Almac’s position as an integrated service provider in the pharmaceutical development sector.” said John McQuaid, VP Technical Operations.

For further information on our Pharmaceutical development services, please visit us at booth # 42L08.

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Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility

admin — Mon, 14 Jan 2013 09:18:51 +0000

Almac is pleased to announce the expansion of our drug product Pharmaceutical Development services with the creation of a new non-GMP formulation development facility and two new analytical laboratories at our UK headquarters in Craigavon. The new facilities double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients

The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

Whereas, the existing GMP facilities can support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on lab-scale experiments, with batch sizes ranging from <1kg up to an expected maximum of 15 kg scale for most technologies.

John McQuaid, VP of Technical Operations explains “Our priority was to ensure we had good integration of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies which is why it was also important that we doubled our analytical capacity in parallel.”

The Almac Group provides a broad range of pharmaceutical 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 and is headquartered in Craigavon, Northern Ireland. Its North American Headquarters are in Souderton, Pennsylvania and the company also has sites at North Carolina and California.

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Almac Announces Expansion of Pharmaceutical Development Facilities

admin — Thu, 20 Oct 2011 09:13:34 +0000

Almac is pleased to announce the expansion of our Pharmaceutical Development services with the creation of a new facility at our UK headquarters in Craigavon.

With an initial investment of £4.5million, phase one of the expansion will provide a state-of-the-art, non-GMP formulation development facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.

The new formulation development suites will complement Almac’s existing pharmaceutical development facilities and will include high levels of control over environmental conditions as well as extending current capabilities in processing high-potent compounds with OEL’s as low as 0.03μg/m³.

The current GMP development facilities focus on drug products up to pilot scale & registration, whereas, the new facility will operate at lab-scale, with batch sizes for most technologies typically expected to be less than 15 kg scale.

John McQuaid, VP of Technical Operations explains “Almac’s intention is to ensure that there is a seamless transition between development and GMP phases of projects in early stage clinical development. Additionally the scale we have chosen will support the growing area of process DoE studies for candidates in late stage development.”

Phase two of the project will involve a significant expansion of GMP analytical support capabilities with the construction of 2 additional QC laboratories within the new facility.

“The new facilities will effectively double our current pharmaceutical development capacity allowing us to meet the growing demand for our services, both from existing and new clients. Recruitment of experienced formulation and analytical development staff has already commenced in support of this exciting expansion” stated McQuaid.

Phase one of the expansion is due for completion mid 2012 with Phase two of the expansion and configuration of dedicated analytical labs completing towards the end of 2012.

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Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies

admin — Wed, 11 May 2011 08:54:58 +0000

Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies

Almac is hosting its inaugural European Product Launch workshop in Boston, MA on 17^th May 2011. Targeted specifically at the biopharmaceutical sector, the workshop provides consultative advice and services to US companies to successfully launch drug products onto the European market.

The workshop will provide US companies with important market and regulatory framework knowledge, whilst guiding them through the European product launch process right through from submitting an MAA to final distribution of drug products to end-users.

Attendees will also learn from the real life experiences of 3 of Almac’s many US clients who have successfully launched drug products into the European marketplace including: Eisai Inc, Millennium: The Takeda Oncology Company and The Medicines Company.

Ian Markwell, VP of Quality for Almac’s Pharma Services business unit commented ‘This workshop provides a significant opportunity for US companies to learn first hand of the processes of launching product into Europe, as many companies based outside the EU, find the European regulatory and quality framework complex.’

One of the key presenters at the workshop Ms Trudy Burke, Senior Director, Baltimore & Gliadel Operations, Eisai Inc remarked: ‘I am delighted to share my experience of partnering with Almac, while helping to advise US companies on the challenges of launching a high value, temperature sensitive product in Europe.’

Further details of this workshop can be found at http://almaceuproductlaunch.eventbrite.com or by contacting Tania Davis (Tania.davis@almacgroup.com) directly.

ENDS

Contact:

Tania Davis

Almac Pharma Services

T: +44 (0)28 3836 3363

E : tania.davis@almacgroup.com

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

About Almac Group

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, pharmaceutical development, clinical trial supply and IXRS^® technology (IVRS/IWRS), to commercial-scale manufacture and packaging. 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 North American Headquarters located in Souderton PA.

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

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Almac completes its expansion plan to Pharma Services facilities

admin — Mon, 19 Apr 2010 13:51:49 +0000

The post Almac completes its expansion plan to Pharma Services facilities appeared first on Almac.

Almac adds Xcelodose® 600S Precision Powder Micro-dosing System to its Product Development Capabilities

admin — Wed, 10 Feb 2010 17:29:23 +0000

New technology decreases processing time and API use – generating significant cost savings

Almac, an integrated contract development and manufacturing organization supporting the international pharmaceutical and biotechnology industries, has further enhanced its offering by adding an Xcelodose® 600S precision powder micro-dosing system to its Product Development capabilities in response to client requirements for preclinical and early phase clinical GMP supply.

For simple formulations of API or powder-in-capsule, the Xcelodose® system can significantly reduce processing time and API usage resulting in cost savings when compared to hand filling options

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times,” said John McQuaid, Technical Development Manager.

McQuaid added:, “Whilst Almac has always offered API in capsule shells, we now see examples of some clients maintaining this approach through to phase 2 studies in an attempt to compress their overall development timelines, requiring significant quantities of capsules for which an automated solution is best.”

Complementing Almac’s existing containment capabilities for processing compounds with an OEL ranging from 0.03 – 10μg / m3 / 8hrs TWA, the Xcelodose® 600S system will include an Xcelohood™ system to offer containment when filling capsules with API of high or unknown toxicity.

David Edwards, Capsugel’s Director of Pharmaceutical Technology commented: “We are delighted to be working with Almac in this area. We see this as yet another recognition by pharmaceutical companies that the use of the Xcelodose® system and ‘API in a capsule’ dosage forms are valuable tools for speeding up the process of early stage pharmaceutical development in both Phase 1 and Phase 2 studies.”

The Xcelodose® system, manufactured by Capsugel, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or API directly into capsules with a high level of accuracy. The Xcelodose® system can dispense amounts as low as 100 micrograms and up to 100 milligrams and beyond, into capsules from size 00 to 4. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit minimizes overall development time by simplifying analytical and stability protocols.

Almac will install the Xcelodose® system in its state-of-the-art product development facility in Craigavon, UK. The unit will be installed and validated, ready for use from March 2010.

– ENDS –

For further information contact:

John McQuaid

Technical Development Manager

Almac Pharma Services

T: +44 (0) 28 3836 3363

E:john.mcquaid@almacgroup.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

Sue Peffer

Marketing & Commercial Executive

Capsugel

T: +44 1304 644791

E : sue.peffer@pfizer.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.

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.

About Capsugel:

Capsugel, a division of Pfizer Inc. with over 2,800 colleagues and ten facilities around the world, is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, softgel, and vegetarian capsules, to innovative R&D equipment and liquid formulations as part of its Licaps® Drug Delivery System, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production. For more information about Capsugel, visit www.capsugel.com.

Xcelodose® and Xcelohood™ are trademarks of Capsugel.

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Almac Completes Phase 1 of its Expansion Plan to Pharma Services Facilities

admin — Tue, 30 Jun 2009 17:17:33 +0000

New £9m facility will ‘meet growing business need for its integrated product development and commercial services.’

Almac Pharma Services have today announced the completion of Phase 1 of the expansion to the company’s existing facilities at the Group’s headquarters in Craigavon, Northern Ireland. Supported by Invest Northern Ireland, a total of £9m will be spent over the two phases of the investment.

Phase 1 has seen the completion and handover of a three story extension to the existing commercial manufacturing facility which has expanded Pharma Services’ laboratory and office areas by 30,000 ft2. The new state–of-the-art laboratories enhance the existing analytical and microbiological services.

Phase 2 of the investment is ongoing and will see the expansion and update of the administration areas, and will be completed later in the summer.

This investment is part of the continued growth of the Almac Group that has seen recent completion of a specialist storage facility in Craigavon, and also the ongoing development of our 240,000 ft2 US Headquarters in Pennsylvania.

Graeme McBurney, President & M.D of Almac Pharma Services said: “Increased client demand for our integrated services, from Product Development to Commercial Supply, has resulted in this investment and expansion. Analytical and project management expertise and support in these service areas are a key part of providing a complete solution to our client partners.

“The provision of expert and consultative analytical services has also been key to our continued growth, and this significant investment allows for ongoing expansion, both in terms of space and the additional team members we will be recruiting. I look forward to working with the current and new members of our team to ensure Pharma Services’ success continues,” he added.

Welcoming the announcement, Enterprise Minister Arlene Foster said: “Almac is now one of the most respected, innovative companies operating in the highly competitive global pharmaceutical industry. This £9m expansion, supported by Invest NI, demonstrates Almac’s focus on servicing growing international demand for its specialist analytical services. Almac’s success is due entirely to the cutting edge research capability, expertise and commitment to business excellence which exists across the Group.”

-End-

Contact

Tania Davis

Almac Pharma Services

Tel: +44 2838 363363

Carl Whyte

Stakeholder Communications

Tel: +44 2890 339949

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/Web/EDC), 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 08 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

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Almac Pharma Services Extend Formulation Facilities

admin — Fri, 10 Nov 2006 17:34:12 +0000

Almac Pharma Services is extending it’s formulation facilities with the opening of a revamped, technology-rich 10,500 ft 2 building, at the company’s United Kingdom headquarters later this month. The enhanced facility represents an investment of $10.5 million and strengthens the company’s offering to the global pharmaceutical and biotechnology industries

The custom-designed facility will operate to full cGMP, providing extended formulation development services in solid oral dosage forms from pre-clinical through to pilot scale. This advancement, will provide classified facilities (ISO 8 / Class 100,000) including laboratories with independent temperature and humidity controlled zones and self-contained suites – many with High Containment capabilities. Our highly skilled scientists can use just milligrams of your valuable API to prepare supplies for first time in-man (FTIM) studies, or can develop and optimise your formulation to progress it through to commercial manufacture.

Almac Pharma Services, President and M.D, Graeme McBurney said the investment represents a significant element of the overall future growth strategy of Pharma Services.

“We at Almac Pharma Services are entering into a new and exciting phase in our development. We are investing to expand the breadth and depth of an already comprehensive suite of commercial services. We work with an increasing number of clients, supporting their needs at each stage of the drug product life cycle, including formulation development, clinical batch production, commercial scale manufacturing, packaging and global supply chain management.”

“The services offered by Almac Pharma Services are world-class and have a global reach. Being part of the Almac ‘family’ means that our staff and our clients have an opportunity to benefit from the entire Almac Group skill-set and infrastructure.”

Almac Chairman Sir Allen McClay said: “The level of investment associated with this move shows our commitment to our operations in Craigavon, as well as Almac’s long term focus on developing fully integrated pharmaceutical services, from drug discovery through to commercialisation.”

Almac Pharma Services, a division of the Almac Group, is headquartered in Craigavon, United Kingdom with offices in Audubon, USA, and is dedicated to continually developing processes and technologies, to remain at the forefront of innovation and to offer comprehensive, flexible, outsourcing solutions from formulation to finished product.

-Ends-

Contact:

Clare Ward	Jim McGibbon
Almac Pharma Services	Almac Pharma Services
+44 (0)28 3836 3363	+1 (610) 671 8568

pharmaservices@almacgroup.com

Brendan Mulgrew

Stakeholder Communications

+44 (0)28 9033 9949

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PDMS Extend Formulation Development Facility

admin — Mon, 20 Mar 2006 17:43:35 +0000

PDMS announce extended formulation development facility.

pharmaservices@almacgroup.com

T: +44(0)28 3836 3363

The post PDMS Extend Formulation Development Facility appeared first on Almac.

PDMS Awards Major Pharmaceuticals Manufacturing System Contract to SSI

admin — Mon, 09 May 2005 17:45:52 +0000

International pharmaceuticals company Pharmaceutical Development and Manufacturing Services Limited (PDMS) has selected an ERP solution based on TROPOS from SSI as the core management system for its expanding global services business. TROPOS will help competitive positioning for PDMS by integrating client services with improved materials and manufacturing planning. It will ensure compliance with essential industry regulatory requirements including FDA Title 21 Code of Federal Regulations (21 CFR Part 11), and enable group wide financial reporting.

Northern Ireland based PDMS is an outsourcing partner to the international pharmaceutical and biotechnology industries. Originally the formulation and manufacturing arm of Galen Limited, PDMS became a separate commercial operation in December 2003. Since then, it has grown its business to manage 220 product lines for clients in North America and Europe. Now part of Almac Sciences, PDMS plans to expand its customer base and its drug formulation business.

PDMS had four main objectives for a new system platform in mid 2004. It wanted automated real-time management reporting and the flexibility to run reports with good query options, so that it could schedule and forecast efficiently, and manage and value stock cost-effectively.

To improve its client services, PDMS wanted to integrate sales ordering processes with Material Requirements Planning (MRP) to produce real-time customer reports. To compete successfully for North American business, it needed to comply with the FDA 21 CFR Part 11, which includes requirement for electronic records and signatures. PDMS also needed the ERP, manufacturing and supply chain system to provide tightly coupled integration with Almac Sciences’ standard financial reporting software Oracle Financials.

PDMS conducted a detailed requirements analysis in 2004 and initially engaged 11 potential suppliers for a replacement 50 user system. Following a filtering process, three short-listed suppliers, including SSI, were invited to present demonstration workshops. SSI was scored as the lead candidate. Following reference visits to other TROPOS customers in pharmaceuticals development and manufacturing, SSI was awarded the hardware, software and services contract in April 2005.

The software modules selected include TROPOS Pharmaceutical Manufacturing and TROPOS Supply Chain. PDMS is also taking TROPOS Application Development and TROPOS Integration Tools, Cognos Business Intelligence, Oracle Database and Oracle Financials. Hardware includes HP Application and Web Servers, using Windows, and Radio Frequency mobile data collection devices for manufacturing materials and data tracking. SSI will supply implementation consultancy, project management, technical and application training and support services.

Managing Director, Graeme McBurney, says that PDMS chose the TROPOS solution mainly because “TROPOS fitted with our business practices and our plans for future integration with other manufacturing execution systems (MES). It also had good practical add-ons, like the reporting toolbox. And we knew that TROPOS integration with Oracle Financials was proven.”

PDMS also responded well to SSI’s genuine interest, experience and openness about the solution’s capabilities, including areas where configuration would be required to meet specific requirements. It liked the fact that TROPOS is SSI’s own product. “We felt more than happy that SSI understood their own product well, and had good knowledge of the needs of our industry and regulators.”

SSI Managing Director, Trevor Lewis believes that SSI was able to exhibit its specialist capabilities in winning the PDMS contract. “ERP and manufacturing solutions for regulated manufacturers are our key specialisation at SSI. So I’m delighted that this came across so strongly to PDMS. We are very proud that PDMS has chosen a TROPOS platform. It enhances our position in this very demanding market sector.”

“We are looking for international success in our current and new market sectors”, says Graeme McBurney. “We think PDMS has the right business infrastructure in plan to help us achieve that. The TROPOS solution will meet our immediate ERP, client and regulatory requirements, but it’s also flexible enough to grow and integrate with other systems in future.”

pharmaservices@almacgroup.com

T: +44(0)28 3836 3363

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Pharmaceutical Development Archives - Almac

Almac Group Expands Bioavailability Enhancement Capabilities – Addressing a critical need in drug development

Almac Pharma Services Opens Doors on £65m New Commercial Manufacturing Facility

Almac Pharma Services expands with exciting career opportunities

Almac Pharma Services announces recruitment event following major expansion at Craigavon HQ

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

Expert Analytical Solutions

Almac Pharma Services Appoints New VP Finance

Almac Pharma Services Joins European Paediatric Formulation Initiative (EuPFI)

Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities

Almac Pharma Services Supports Rapid Launch of BioLineRx’s APHEXDA® (motixafortide)

Almac Pharma Services Appoints New VP of Business Development

Almac Pharma Services Supports Industry Consortium to Address Titanium Dioxide Alternative Challenge

Amicus Therapeutics Inc and Almac Pharma Services Mark 15-year Strategic Partnership with Patient Advocacy Event

Almac Pharma Services Appoints New Director of Manufacturing Science and Technology

Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Almac Group Awarded six 2024 CDMO Leadership Awards

Almac Pharma Services Renew HPRA GMP Certification for European Facility

Almac Pharma Services Receives Brazilian ANVISA GMP Certification for US Facility

Almac Group releases details of £80 million expansion in Northern Ireland

Almac Pharma Services Hosts Recruitment Open Day in Loughborough

Technical Quality Team Leaders Graduate with Masters in Pharmaceutical Validation Technology

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

Almac Pharma Services Announces Two Vice President Appointments

Almac Pharma Services Recruiting Senior Operators in Charnwood

Almac Pharma Services Supports Rapid Launch of Provention Bio, Inc.’s Treatment TZIELD™ (teplizumab-mzwv)

First and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and paediatric patients aged eight years and older with Stage 2 T1D

Almac Pharma Services Supports Packaging and Supply of PTC Therapeutics’ Gene Therapy Upstaza™ for EU Launch

Tailored ultra-low temperature solutions enabled first and only approved disease-modifying treatment for AADC deficiency to be approved by EMA

Almac Group Announces New COO and Appoints New Almac Pharma Services MD

Almac Group Recognised in Life Science Leader CMO Awards for the Eighth Time

Almac Group’s Charnwood Site Achieves Globally Recognised Health & Safety and Environmental Management System Certifications

Almac Pharma Services Launches Trainee Recruitment Drive

Almac Pharma Services Achieves Unprecedented Global Regulatory Milestone

Three successful regulatory inspections completed in two weeks

Almac Group Recognised with Six Life Science Leader CMO Awards

Almac Group Announces Successful HPRA Inspection at its European Campus

Almac Group Appoints New Site Head for Charnwood Campus, Loughborough, UK

Almac Group Appoints Three Vice Presidents

Almac Group Expands US Specialised Commercial Packaging Capabilities

Almac Group Announces Successful MHRA Inspection at Charnwood Facilities

Almac Group Expands Commercial Capabilities to Meet Industry Demand for Paediatric Formulations

Almac Group announces significant expansion in pharmaceutical development capacity

Almac invests to accelerate formulation development services

Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility

Almac Announces Expansion of Pharmaceutical Development Facilities

Almac to host inaugural European Product Launch workshop for US Biopharmaceutical Companies

Almac completes its expansion plan to Pharma Services facilities

Almac adds Xcelodose® 600S Precision Powder Micro-dosing System to its Product Development Capabilities

Almac Completes Phase 1 of its Expansion Plan to Pharma Services Facilities

Almac Pharma Services Extend Formulation Facilities

PDMS Extend Formulation Development Facility

PDMS Awards Major Pharmaceuticals Manufacturing System Contract to SSI