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

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

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

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

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

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

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

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

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

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

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

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

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

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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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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 and Provention Bio, Inc Celebrate Rapid Launch of TZIELD™ (teplizumab-mzwv)

amoreland — Tue, 14 Feb 2023 13:00:00 +0000

Audubon, PA, USA – 8 February 2023 – Almac Pharma Services was delighted to welcome the Provention Bio Inc’s management team to celebrate the successful packaging and rapid launch of Provention Bio Inc’s first biologic treatment, TZIELD™ (teplizumab-mzwv) into the US market.

TZIELD* was approved on November 17 by the U.S. Food and Drug Administration for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 Type I diabetes (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.

The Provention Bio Inc’s team toured the Almac Pharma Services’ Audubon, PA facility and met with some of the team who have been key to ensuring their product had a smooth and successful launch. Culminating in a celebratory lunch and presentation to the operational staff, sharing insights into the patient journeys that have been key in the development and delivery of TZIELD™. The visit was proposed by Provention Bio Inc as an opportunity to recognise and thank the operational teams who work so hard on packaging and preparing their drug product for market.

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. This visit further solidifies the by Almac Pharma Services and Provention Bio Inc, to advance the treatment of T1D to patients.

Harry Lindenmuth, VP Operations Audubon, Almac Pharma Services commented: “We are pleased to have Provention Bio, Inc join our teams on site to celebrate the successful launch of their first biologic treatment. Almac Pharma Services is delighted to have played a role in packaging this key advancement. Being able to mark this occasion with Christina and the Provention Bio Inc management team has been very meaningful to our own team. Seeing the patient journeys has been particularly impactful.”

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.

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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.

“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.”

#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.

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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 Clinical Supply and Commercial Solutions Support Agios’ Road to FDA Approval

allie — Tue, 22 Mar 2022 13:00:00 +0000

Almac Group welcomes U.S. FDA Approval of First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase (PK) Deficiency

Almac Group, the global contract development and manufacturing organisation, is proud to confirm it has supported Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, in the clinical trial and rapid commercial launch of PYRUKYND® (mitapivat).

The treatment is the first ever U.S. Food and Drug Administration (FDA) approved, disease-modifying therapy for adults with hemolytic anemia caused by PK (pyruvate kinase) deficiency, a rare, debilitating, and lifelong form of anemia.

Almac’s engagement with Agios began in 2014, while the treatment was under clinical study. During the pivotal Phase 3 study, Almac Clinical Services provided global clinical supply chain expertise to assist in bringing AG-348 / PYRUKYND® (mitapivat) to market. Almac Clinical Services provided a full suite of end-to-end clinical supply solutions including expert packaging, labelling, distribution and QP Services, all while working collaboratively with Almac Sciences and Almac Pharma Services to create a seamless bridge between Clinical and Commercial.

Most recently, Almac Pharma Services, which specialises in product development and commercial services, provided rapid launch commercial services in anticipation of FDA approval. This bespoke, proactive service leverages Almac’s highly experienced and tailored manufacturing and logistic expertise to anticipate and execute the bespoke printing, packaging, labelling, and shipment of a drug within hours of U.S. Food and Drug Administration Approval from the company’s Craigavon, Northern Ireland global headquarters.

Dr Robert Dunlop, Managing Director & President, Almac Clinical Services, states, “We send our congratulations to Agios on the FDA approval of PYRUKYND®, we hope this outstanding achievement will significantly improve the quality of life for patients who are living with this debilitating disease. We are proud to have supported this important clinical study and to work in partnership with Agios to deliver crucial supplies to trial patients. I would like to thank those within Almac Clinical Services who worked extremely efficiently to ensure timelines were met and product was delivered on time.”

Graeme McBurney, Managing Director & President, Almac Pharma Services, commented, “We are delighted to congratulate Agios on the FDA approval of PYRUKYND®, a remarkable step forward for patients who suffer from PK deficiency. As an organisation with a mission to advance human health, we have been honoured to support this work that addresses an unmet medical need and provides an unprecedented therapy for those patients who need it most. I would also like to thank our team at Almac Pharma Services, whose ongoing dedication has enabled the seamless, rapid launch of this product into the U.S. commercial space.”

“We are grateful to the team at Almac for their dedication to providing the highest quality service and care for people with PK deficiency in our clinical trials and those who are now getting access to the commercial product for the first time,” said Wendy Xia, Vice President Supply Chain, Agios. “Almac shares our deep commitment to supporting and partnering with the PK deficiency community, and with their collaboration, we have been able to expediently and seamlessly bring PYRUKYND® from the clinic to patients who previously had no approved treatment option.”

#ENDS#

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Almac Pharma Services Expands its Unique Ultra-Low Temperature Solutions for Advanced Therapy Medicinal Products

thomasdrake — Mon, 14 Mar 2022 08:30:00 +0000

Tailored service enables processing and QP release within 20 hours

Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has expanded its state-of-the-art Ultra-Low Temperature commercial packaging, labelling and distribution solutions to support the launch of Advanced Therapy Medicinal Products (ATMPs) from its European Centre of Excellence.

Almac Pharma Services was one of the first European CDMOs to support Gene Therapy product launches and currently provides solutions for over 30% of EU approved/pre-registration ATMPs having processed and QP released over 600 batches to date. The specialist team offers its global clients a wealth of expert knowledge, deep understanding, and unique partnerships enabling the processing and release of tailored treatment in as little as 20 hours.

Almac’s bespoke solutions of Just-in-Time labelling, packaging and serialisation at ultra-low temperatures
(-20°C to -80°C) has been enhanced to offer clients a uniquely tailored experience ensuring every step of the highly complex process is adjusted to meet the specific requirements of both the client and the valuable product. In addition, a dedicated team of fully qualified and licenced QPs is on hand to provide expert advice on every aspect of ATMP launch offering a bespoke end-to-end consultancy service.

Robert Smith, Fellow of the Royal Pharmaceutical Society of Great Britain and Consultant QP to Almac Pharma Services noted, “As a result of the nature of these therapies, QP release of ATMPs requires an advanced level of knowledge, training and certification to ensure they understand the biological processes and the variability this brings. It is imperative, therefore, to partner with an experienced CDMO – like Almac – to facilitate and expedite this crucial stage and have confidence that product will be delivered to the patient as quickly as possible.”

Almac’s proven track record and expertise in temperature-controlled logistics combined with its long-established relationships with reputable, experienced and trusted global supply chain providers offers clients a comprehensive end-to-end service guaranteeing expedited delivery direct to patient. Almac’s use of innovative shippers, temperature monitors and digital platforms which enables real-time visibility into product and shipper conditions, as well as location of the shipment, ensures product will not be compromised during transit.

The dedicated Centre of Excellence is located in Europe 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 market for ATMPs is forecast to expand through the foreseeable future. Indeed, some industry analysists predict as much as 20 percent year-on-year growth through 2025.

Mark English, VP Packaging & Logistics for Almac Pharma Services commented: “These products are high value and, in some cases, lifesaving medication. The specialist handling, packaging, delivery, and administration of ATMPs is highly complex and time sensitive. Often, patients require treatment within days of diagnosis and therefore any delay or product degradation during any stage of processing or delivery could have devastating consequences for their health.

“We are cognisant that we implement robust and timely processes, underpinned by Quality Risk Management and designed to protect the integrity of the product whilst ensuring it gets to the patient on time.

“Through our work with a variety of ATMPs, we understand that each product is unique in its requirements to guarantee its integrity throughout the entire process. Through our deep understanding, experience and tailored offering, we work in close partnership with our clients to identify and agree the most appropriate methods to meet their needs.

“These innovative and personalised treatments rely on packaging and labelling over dry ice to help prevent temperature excursions and limit the time out of condition. As such, our specialist teams are highly trained and work with precision along each critical step of the operation.”

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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 to Host EU Product Launch Workshop Series in California and Washington States

admin — Mon, 05 Aug 2019 07:07:35 +0000

Craigavon, U.K., 05 Aug 2019 – Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, is inviting members of the pharmaceutical and biotechnology industry to join its upcoming complimentary workshop series this September.

During these specifically designed knowledge sharing sessions, Almac’s subject matter experts will guide participants through the product launch timeline from Phase 3 to commercial launch and share valuable insights into the key requirements and considerations to ensure commercial launch in Europe is successful.

The three individual sessions will be hosted on Monday 16th September in the Hilton San Fran Airport Bayfront, San Francisco, CA; the Marriot La Jolla Hotel, San Diego, CA on Tuesday 17th September with the final workshop taking place on Thursday 19th September in the Pan Pacific Hotel, Seattle, WA.

Almac understands that launching drug product can be challenging, especially if sponsors are not familiar with the key milestone requirements that should be met at various time points in the MA submission process. Using real-life scenarios and interactive group discussions, participants will learn about the European regulatory framework and how this determines all launch milestones, understand the importance of the Qualified Person (QP) and QP declarations and identify top operational considerations as you progress to commercialisation and much more.

Workshop host, Adam Schroeder, Director of Business Development at Almac Pharma Services, commented on the upcoming workshop: “We are excited to offer this series of workshops in three significant locations across the west coast. The combination of interactive presentations, round table discussions and networking at these events will prove invaluable for participants wishing to find out more about launching their product into Europe. We look forward to sharing our industry insights and expertise with those attending in September.”

To find out more and to sign up, please click here.

ENDS

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 Group to Host EU Product Launch Workshop Series in California and Washington States 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 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.

###

About Almac Group

‘Partnering to Advance Human Health’

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

The post Almac Group Expands US Specialised Commercial Packaging Capabilities appeared first on Almac.

Almac Group announces further expansion at its European Campus in Dundalk

admin — Thu, 18 Jan 2018 08:00:54 +0000

Craigavon, N.I., 18 January 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, today confirmed the successful completion of Health Products Regulatory Authority (HPRA) inspections of Almac Clinical Services Ireland and Almac Pharma Services Ireland at its European campus in Dundalk, Ireland.

Almac previously confirmed that it secured new premises in Dundalk, Ireland in January 2017 as part of its ongoing global expansion strategy, to meet client demand and to address any potential challenges that may arise due to Brexit.

Following these successful HPRA inspections, Almac Group look forward to being officially licensed to conduct QP batch certification and release for both clinical trial material and commercial drug product from its European campus in Dundalk.

Ensuring the Group meets current and future client needs in the European Union marketplace, Almac has today announced further investment at the campus including a new QC laboratory and packaging facility for commercial drug products and a dedicated 79,000ft² EU Distribution Centre for clinical trial supply. This investment will more than treble the GMP footprint at its European campus which is scheduled to be operationally ready by January 2019.

This thirty million pounds investment complements the existing clinical supply and drug product development operations offered from its Global HQ site in Craigavon, NI – just 40 minutes by road from the new European campus.

The new European campus significantly increases the Group’s global footprint and provides an expanded presence within the European Union for both clinical trial supplies and commercial drug product operations, thereby providing uninterrupted service provision to its global clients.

Over the last 18 months, Almac has invested significantly, with the expansion of operational capabilities and employee numbers in each of its key territories including USA, Asia and UK. This announcement is part of a wider global expansion strategy. It will be paralleled with further investment and plans to increase employee headcount in all these locations in the coming 18 months, including its Global HQ in Craigavon, UK.

Alan Armstrong, CEO and Chairman of the Almac Group commented: “Achieving these successful HPRA inspections is a key milestone. In addition, the announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU marketplace. Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring, and for the future, keeping Almac as a global leader in the life sciences sector.”

Welcoming the announcement Minister for Business, Enterprise and Innovation Heather Humphreys TD said, “This decision by Almac is a great vote of confidence in Dundalk, especially coming so soon after their initial decision to develop an operation in the area. It further strengthens Ireland’s Life Sciences capability in the North East and builds on a series of new IDA projects announced for Dundalk and elsewhere in County Louth over recent times. This exciting new facility is a further example of the success of our commitment under the Regional Action Plans for Jobs to provide quality jobs in regional locations.”

Commenting on the announcement Martin Shanahan, CEO, IDA Ireland said “This further investment in Almac’s European Campus in Dundalk is a very positive development for the company and the North East region. The Irish facility plays a strategically important role within Almac’s global footprint. Companies continue to choose Ireland as a location which provides certainty of access to the European Union in the long term post Brexit.”

ENDS

About Almac Group

‘Partnering to Advance Human Health’

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

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

The post Almac Group announces further expansion at its European Campus in Dundalk 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.

Petya ransomware attack – Almac update

admin — Fri, 30 Jun 2017 13:27:43 +0000

As previously notified, Almac systems remain unaffected by the Petya ransomware attack.

Due to the ongoing issues being experienced by TNT air freight, Almac is achieving normal service (including full track and trace) for all outbound shipments through the use of our alternative Courier Service providers. We will also work to close any legacy issues directly with TNT air freight and secure Proof of Delivery for shipments affected to date.

Updates will continue to be provided by your Almac Project Leader / Manager as appropriate.

Almac is committed to continuity of supply for patients and customer service excellence and will endeavour to mitigate any impact due to this current situation.

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Almac to Exclusively Share Global Expertise in EU Product Launch Workshop

admin — Wed, 15 Mar 2017 08:54:18 +0000

Craigavon, N.I., 15 March 2017 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce a free, one-day exclusive knowledge sharing workshop entitled ‘Considerations for EU Product Launch’ on Thursday 11 May 2017 at The Carlton Hotel Dublin.

This complimentary workshop will discuss key aspects regarding launching a product into Europe with a focus on niche and orphan drugs and will include:

European regulatory framework
The importance of the role of the Qualified Person (QP)
Key considerations for packaging, selection and design
Strategies for stock optimisation
Managing a complex EU supply chain
Considerations for a temperature sensitive product

A number of Almac’s subject matter experts, including VP Commercial Operations, David Downey, will join key thought leaders from PTC Therapeutics, Shire Pharmaceuticals and Quickstat to share real world experiences and provide unique advice gained in their respective fields of expertise.

The information presented during this free workshop will guide attendees through the EU launch process, from submitting an MAA, to final distribution of drug product to the end-user. Attendees will leave the workshop with a wealth of advice and be better prepared for what is ahead and ensure their commercial launch is successful.

With over 40 years’ experience, Almac is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries. In the last three years alone, the company has supported the successful launch of more than fifteen first-to-market orphan drug products.

David Downey commented: “Companies face a number of challenges when launching a product into Europe for the first time. Almac understand the complexities involved in the entire end-to-end process and this complimentary workshop is an opportunity for us, in partnership with key industry leaders, to share our expertise, advice and knowledge in a range of pertinent areas in this field.”

To find out more and to sign up, visit: EU Product Launch Workshop Agenda.

~ENDS~

Notes for Editors:

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 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

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

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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

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Almac Group’s Integrated Development to Commercialisation Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product

admin — Tue, 02 Aug 2016 09:08:16 +0000

Craigavon, N.I., UK, – 2 August 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner, Amicus Therapeutics on the European approval of its first orphan drug product and precision medicine Galafold™ (migalastat, also referred to as AT1001). Galafold was approved as a first line therapy for long-term treatment of adults and adolescents (aged 16 years and older) with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

The Almac / Amicus partnership began in 2009 when Amicus sought an outsourcing partner for Phase III clinical manufacture and packaging of its solid oral AT1001 compound. Almac’s Pharmaceutical Development and Clinical teams worked with Amicus to advance the drug product through scale up, registration and now onwards into commercial supply. Almac is manufacturing and packaging the drug product and supporting Galafold’s launch across Europe from its UK Headquarters in Northern Ireland.

Leveraging the Almac advantage of integrated development and commercial services ensured a smooth transition from development to commercialisation for Amicus. Utilising the experience of Almac’s multidisciplinary product launch team incorporating quality, packaging design, regulatory and distribution, aided Amicus in navigating EU market requirements. Upon marketing authorisation (MA), Galafold was packed and distributed to the German market within hours ensuring patients’ needs were met as quickly as possible.

David Downey, Vice President, Commercial Operations at Almac commented “It’s great to see the launch of this precision medicine addressing a debilitating unmet medical need and it is gratifying to have played our part in its development and commercialisation. Amicus drew upon many of the services Almac has to offer, from development, through clinic, and into commercialisation. We look forward to a growing partnership as Amicus services the needs of the Fabry patient population who have an amenable mutation.”

“Providing quality drug product and sufficient drug supply is critical to ensuring a successful launch of Galafold for Fabry patients who have an amenable mutation,” said Enrique Dilone, Ph.D., RAC, Senior Vice President, Technical Operations at Amicus Therapeutics, Inc. “Almac has been an outstanding outsourcing partner for Amicus and we look forward to continuing the relationship as Galafold becomes available across the EU.”

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.

About Almac Group

‘Partnering to Advance Human Health’

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.comor e-mail media@almacgroup.com.

About Amicus Therapeutics

Amicus Therapeutics is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other lysosomal storage disorders.

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Almac Group’s Rapid Launch Services Support U.S. Approval of Intercept Pharmaceutical’s First Commercial Orphan Drug Product

admin — Thu, 14 Jul 2016 08:23:17 +0000

Craigavon, N.I., UK, – 14 July 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva®. Ocaliva has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The partnership between Intercept and Almac commenced in 2013, with Almac’s Pharmaceutical Development teams supporting the early phase development of various dosage forms of Ocaliva. Building on this partnership, Almac’s commercial teams have worked with Intercept for the commercial packaging including packaging design & artwork of the now FDA approved drug product Ocaliva.

Intercept received accelerated FDA approval on Friday, 27th May 2016, and utilising Almac’s commercial Rapid Launch program, delivered from its Audubon, Pa. commercial packaging facility, Ocaliva was successfully packed and distributed on Tuesday, 31st May after the Memorial Day holiday to Intercept’s specialty pharmacy network.

Almac will also support the anticipated EU launch of obeticolic acid, if Intercept receives marketing authorisation, together with bulk drug product manufacture from its commercial manufacturing and packaging facility at its UK Headquarters in Craigavon, Northern Ireland.

David Downey, VP Commercial Operations, commented, “Leveraging development and commercial teams, located both in the UK and US, illustrates Almac’s value proposition of service and team integration. This approach reduced lead-time, mitigated risk and managed challenges, which led to a successful rapid launch within 48 hours of FDA approval over a Memorial Day weekend. My congratulations to all those involved.”

“Our collaboration with Almac will help address the unmet need in PBC by bringing Ocaliva to U.S. patients living with the disease,” said Richard Lancaster, Senior Director, Product Development at Intercept. “We look forward to a continued partnership as we prepare for the anticipated EU approval.”

About Almac Group

‘Partnering to Advance Human Health’

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

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Almac Group Launches US Serialisation Solution in Partnership with Optel Vision

admin — Mon, 25 Apr 2016 07:50:47 +0000

Craigavon, N.I., UK, – 25 April 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce an expansion to its serialisation capabilities to include its US commercial packaging facility in Audubon, PA.

Building upon Almac’s in-house expertise and proprietary serialisation / track and trace solution developed at its UK headquarters, this technology expansion will address FDA regulations meeting the requirements outlined in the Drug Quality and Security Act together with meeting client demand for a local US, flexible, contract packaging serialisation provider.

Having assessed multiple vendors, Almac partnered with Optel Vision to provide a versatile line level solution (hardware and software) that integrated with Almac’s in-house proprietary level 3, site level software. This new serialisation solution is a high-spec standalone line that prints, verifies and aggregates saleable packs through to the pallet with reporting functionality to ensure the client can meet the traceability requirements of the various markets.

Grainne Hughes, Operations Manager at Almac explains “Having built our own serialisation line for the UK operations some years ago we developed a strong knowledge base. To expand the solution into our US operations we decided that we needed an experienced partner that could integrate with our innovative product serialisation site level software. The partnership with Optel Vision has provided our US commercial packaging facility with a truly flexible and adaptable solution to readily meet specific country, market and client requirements whilst ensuring serialisation to GS1 Standards.”

“We knew Almac had its own in-house solution for the UK and for the first Almac serialisation project in the US, we combined the knowledge of both companies to design a solution that meets Almac quality standards as well as the demand from global markets using the Optel Vision hardware and software solutions. The system is now operational and can be easily scalable for future needs.” says Yvon Lemay, Optel Vision Project Manager.

Almac US can now offer the flexibility to our Clients to serialise as part of the pack process, as part of a repackaging exercise, or as a stand-alone serialisation application to already packed product.

About Almac Group

‘Partnering to Advance Human Health’

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

Almac’s serialisation experts will be attending Interphex New York (26 – 27 April) and Making Pharmaceuticals Birmingham (26 April).

About Optel Vision

Optel Vision is the leader in providing the most technically advanced systems for Vision Inspection and Track & Trace Solutions. Optel Vision’s systems ensure the safety of manufactured goods by inspecting package integrity and applying anti-counterfeiting measures.

For more information visit www.optelvision.com.

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Almac Wins Three CMO Leadership Awards

admin — Wed, 23 Mar 2016 15:48:36 +0000

Craigavon, N.I., UK, – 23 March 2016 We are pleased to announce that we have once again been selected as winners at this years’ CMO (Contract Manufacturing Organisation) Leadership Awards for the fifth year. The award was presented to VP of Commercial Operations, David Downey at an exclusive ceremony and reception in New York last week (16 March).

The awards are developed by Life Science Leader with the sole purpose of recognising the industry’s top CMO’s. The research was carried out by Industry Standard Research (ISReports.com) and based on their Contract Manufacturing Quality Benchmarking annual online survey. More than 80 contract manufacturers were evaluated on 26 different performance metrics.

There are five CMO Leadership Award core categories: Quality, Reliability, Capabilities, Expertise, and Compatibility. Multiple performance metrics feed into each of these award categories to give added confidence to Almac. Almac has emerged as the winner of three of these categories:

COMPATIBILITY – Met customers’ expectations
QUALITY – Met customers’ expectations
RELIABILITY – Met customers’ expectations

David Downey, VP Commercial Operations commented:

We are pleased to have received yet another CMO Leadership Award for these three key categories. We pride ourselves on our ability to provide high quality, flexible and innovative solutions to meet our global clients’ requirements and these awards are recognition of our teams’ ongoing commitment to deliver just that.”

About Almac Group

‘Partnering to Advance Human Health’

Almac Diagnostic Services is one of six business units operating under the ownership of the Almac Group. The global company partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics. In addition, Almac Diagnostic Services has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

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

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Almac Group Addresses Industry Demand for Multiparticulate Drug Products with Scalable Fluid Bed and Encapsulation Technologies

admin — Wed, 07 Oct 2015 08:22:02 +0000

Craigavon, N.I., UK, – 07 October 2015 In response to increasing client demand for multiparticulate drug delivery systems, Almac Group, the global contract development and manufacturing organisation, is providing fluid-bed processing and encapsulation services to its global partners from its UK development and commercial manufacturing facilities.

Multiparticulate systems — including pellets, beads, granules and mini-tablets — are typically formulated to optimise drug performance, enhance patient tolerance and safety and extend patent protection. Development and scale-up of these dosage forms can be challenging, however, Almac’s clients are seeking the technical expertise and equipment capabilities that provide scalable solutions.

Almac’s most recent addition in multiparticulate technologies is focused on commercial-scale support. Almac has qualified both a Glatt GPCG PRO 120 fluid bed processor and an IMA Adapta 100 high speed encapsulator. The Glatt accepts modular inserts for each of the three common fluid bed processes: bottom spray, top spray or drying. Most recently, Almac’s development and commercial teams have successfully registered and commercially manufactured a product at 250kg scale using the bottom spray Wurster insert. Utilising the dedicated fluid bed drying / encapsulation suite, multiparticulates from those batches were then filled into capsules using our Adapta 100, which has a high throughput capacity of up to 100,000 capsules per hour and an integrated online checkweigher with feedback loop to maintain high yields.

As John McQuaid, VP Technical Operations at Almac, explains “Having both small and large scale fluid-bed and encapsulation technologies allows us to meet our clients’ needs for multiparticulate drug products from early phase clinical supplies through to ongoing commercial demand. Our clients benefit from a single-partner and single-site approach that eases tech transfer, provides scientific continuity and delivers savings in terms of both time and cost.”

About Almac Group

‘Partnering to Advance Human Health’

The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 3,700 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 Group’s Integrated CMC Services Support US Approval of Wellstat Therapeutics’ First Commercial Orphan Drug Product

admin — Wed, 09 Sep 2015 11:02:19 +0000

Craigavon, N.I., UK, – 9 September 2015 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long term client partner Wellstat Therapeutics on the commercial approval of their first orphan drug product XURIDEN™ (uridine triacetate). XURIDEN has been developed as a treatment for the rare disease Hereditary Orotic Aciduria (HOA).

The partnership began more than 5 years ago with Almac’s Sciences and Pharma Services business units providing expert support to Wellstat Therapeutics for the development of both the Active Pharmaceutical Ingredient (API) and formulation of the drug product. Having manufactured clinical, registration and PV batches, Almac will now produce the commercial product from its UK headquarter facilities, on behalf of Wellstat Therapeutics.

Following a successful Pre-Approval Inspection (PAI) of Almac’s UK facilities in May of this year and the subsequent FDA approval of the product on September 4, 2015, XURIDEN is forecast to be commercially available in early 2016.

Leveraging Almac’s unique integrated API and Drug Product expertise prior to and through NDA submission and approval, Wellstat Therapeutics worked with Almac to take advantage of a single partner approach with smooth transition through the drug development process and now commercialisation, saving time, transfers and other uncertainties inherent in a multi-supplier process.

David Downey and Charles Shields, VP’s of Almac’s Drug Product and API teams respectively commented “It is great to see a product that Almac has supported long term in both development of the API and Drug Product achieve commercial approval. The value of integrating development and the flexibility it offers our partners cannot be overstated.”

“Until FDA approval of XURIDEN, there were no approved treatments for patients with hereditary orotic aciduria, a rare, potentially life-threatening disease”, said Michael Bamat, VP Research & Development for Wellstat Therapeutics. “Almac has been an integral part of the API and drug product development team for XURIDEN.”

About HOA

Hereditary orotic aciduria (HOA) is a genetic disorder caused by mutations reducing the activity of uridine monophosphate synthase (UMPS), which converts orotic acid to UMP. Uridine deficiency underlies many of the symptoms of HOA, including hematologic abnormalities, developmental delays, failure to thrive, and if untreated, early mortality. Orotic acid biosynthesis is normally subject to feedback inhibition by intracellular uridine nucleotides and is therefore overproduced in HOA. The resulting increased levels of orotic acid can cause crystalluria and occasional obstructive uropathy.

The goal of uridine replacement therapy in HOA is to provide the uridine that these patients cannot make adequately themselves in order to restore intracellular uridine nucleotide concentrations, enabling and supporting the biosynthetic functions of pyrimidine nucleotides and their derivatives, and also normalizing orotic acid production.

About XURIDEN

XURIDEN is a pyrimidine analog for uridine replacement indicated for the treatment of hereditary orotic aciduria. Oral administration of XURIDEN delivers 4 to 7 times more uridine than oral administration of uridine itself.

Important Safety Information

Contraindications – None

Warning and Precautions – None

Adverse reactions – No adverse reactions were reported with XURIDEN in patients with HOA

Pregnancy – There are no available data on XURIDEN use in pregnant women to inform drug-associated risk

Lactation – There are no data on the presence of XURIDEN in human milk, the effect on the breast-fed infant or the effect on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for XURIDEN and any potential adverse effects on the breastfed infant from XURIDEN or from the underlying maternal condition.

Pediatric – The safety and effectiveness of XURIDEN have been established in pediatric patients.

For the full Prescribing Information go to http://www.xuriden.com/FPI.pdf.

About Almac Group

‘Partnering to Advance Human Health’

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

About Wellstat Therapeutics

Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. Wellstat Therapeutics is part of the Wellstat group of companies, http://www.wellstat.com. For more information, please visit the website at http://www.wellstattherapeutics.com.

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Almac Further Enhance 3rd Party Logistics Commercial Support Services for Niche / Orphan Drugs

admin — Mon, 18 Nov 2013 09:18:24 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce the release of an enhanced 3rd Party Logistics (3PL) Customer Billing Application.

In response to growing client demand for fully integrated end to end support of EU product launches, from import testing, country specific packaging, QP release, online ordering, direct to pharmacy distribution and financial services, Almac have enhanced their customer billing software to facilitate a seamless invoicing process on behalf of 3PL clients.

3PL orders, received directly from hospitals / clinics / pharmacies, for niche/ orphan drug products, will now be processed, dispatched, and automatically invoiced on the client’s behalf. The process will be completed by reconciliation of payments to the client’s EU account, as well as debtor follow up.

David Downey, VP Commercial Operations of Almac explains “With our client partners, we have successfully launched many high-value, orphan drug / niche products into the European market. With this enhancement to our customer billing application, we can alleviate the client’s administrative burden, by essentially becoming an extension of their supply chain team and assist in managing cash receipts and debtor follow up. Particularly for US based clients with no EU operational footprint, this end to end service provides a compelling business case to partner with an experienced EU solutions provider. ”

About Almac

‘Partnering to Advance Human Health’

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

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Almac launches US commercial packaging operations with successful FDA inspection and new client partnership

admin — Wed, 06 Feb 2013 09:14:51 +0000

Almac today announces the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA). The inspection took place on the 9^thand 10^th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.

Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”

Jim McGibbon, US Director of Business Development explained “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”

Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long term client partner of its UK operations for both formulation development and contract commercial manufacture services. Initially Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.

“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.

Almac’s new FDA approved, US commercial packaging facility in Audubon, PA, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.

Notes to Editors

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

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Almac expands UK commercial capacity with the acquisition of new blistering technology

admin — Wed, 03 Oct 2012 08:26:47 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce that it has expanded its MHRA/FDA approved UK commercial packaging facility with the acquisition of a state-of-the-art Noack N 623 blister packaging line from Romaco.

The acquisition comes in response to growing client demand for enhanced flexibility related to larger blister sizes and innovative multi unit blister formats, coupled to a requirement for non permeability and enhanced environmental protection, particularly product humidity control.

This highly flexible, cGMP compliant technology can be configured to process both thermoform and coldform materials, with maximum blister sizes of 220mm x 155mm. With its automatic feeding system, filling inspection and ejection station and shorter set-up times, the line provides increased productivity, processing over 25,000 blisters per hour, including multi-product blisters.

“Blister size and dosage formats are becoming increasingly more complex. Additionally, product handling for innovative new molecules often requires enhanced environmental controls. This investment allows Almac, through its Pharma Services business unit, to offer this additional flexibility,” says Geoff Sloan VP of Manufacturing Operations. “Through this acquisition, coupled with our imminent entry into the US commercial packaging market, we continue to expand our capabilities and flexibility to meet our client’s needs.”

“The blister technology from Romaco Noack offers high OEE values and low lifecycle costs. Product changeovers are carried out easily and cleaning is quickly done. Our machines prove themselves flexible in operation and versatile in use.”, says Bernd Webel, Sales Director, Romaco.

For more information on Almac’s commercial packaging capabilities, visit https://www.almacgroup.com/commercial-services

Almac will be exhibiting at CPHI Madrid, 9^th – 11^th October 2012 (booth number 10E41) and AAPS Chicago, 14^th – 18^th October 2012 (booth number 3027).

Notes to Editors

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

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Almac installs Uhlmann Blister Line in new US Commercial Packaging Facility

admin — Tue, 01 May 2012 08:07:17 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, is pleased to announce the acquisition of a state-of-the-art, high-speed blister line for their new 100,000ft² US commercial packaging facility in Audubon, PA.

The versatile UPS 4 blister line will process solid oral dose products, providing primary packaging into a range of materials including PVC, PVC/PVDC, Aclar and Alu/Alu. Complete with an integrated C2206 cartoner, the line will provide a highly efficient packaging solution with an output of up to 12,000 blisters per hour, in a wide range of blister sizes.

The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital) addressing the need for enhanced patient compliance, whilst ensuring flexibility of supply.

Enhancing product compliance, the line will include a Total Quality Control Center (TQCC) incorporating a checkweigher and integrated print and vision system for auto – rejection of incorrect print / serialisation data including 2D codes.

The blister line will complement the full suite of highly flexible and state of the art commercial packaging equipment already installed in the new Audubon facility. Supporting high volume marketed products to niche/orphan drug launches, additional key technologies include bottling, walleting and vial labelling/packaging.

Geoff Sloan, VP Manufacturing Operations explained that the partnership with Uhlmann, one of the leading US Pharmaceutical equipment suppliers, was a natural choice. “Uhlmann were able to provide us with a versatile, high-spec blistering line to match ourUSclient requirements for a high quality, flexible commercial packaging solution.”

Ralf Klotz, Regional Sales Manager, Uhlmann commented “The construction and installation of this equipment proved to be a great project. We are looking forward to a long term partnership with Almac as their US Operations continues to grow. The flexibility of this equipment certainly puts Almac in a position as a leader in contract blister packaging”.

For more information on Almac’s service capabilities, visit almacgroup.com/uspack. Almac will be exhibiting at Interphex (booth 1109).

Notes to Editors

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

The post Almac installs Uhlmann Blister Line in new US Commercial Packaging Facility appeared first on Almac.

Almac expands in US with addition of Commercial Packaging facility in Audubon

admin — Wed, 07 Mar 2012 10:45:03 +0000

Having identified a business need in the US for a flexible and high quality commercial packaging service provider, the Pharma Services business unit of Almac is proud to expand its established commercial packaging operations with a $10m investment in a new state-of-the-art 100,000ft² commercial facility in Audubon, PA.

Bringing more than 30 years’ commercial packaging experience from its MHRA/FDA approved UK facilities and having established a reputation for delivering high quality, reliable and cost-effective commercial packaging solutions, clients can now leverage this expertise from a local US based operation.

David Downey, VP Commercial Operations said, “Addressing the communicated needs of our Clients, we have taken the strategic step of establishing a US based operation for commercial packaging services. For many years we have been bulk manufacturing and packaging US products from our UK facility. With the addition of the Audubon facility, we will now be able to offer these packaging services local to the US market place, providing cost saving and mitigating supply risks”.

Following completion of the evaluation and feasibility design work, refurbishment of the facility has commenced and systems handover is scheduled for Fall 2012.

Upon FDA approval, Almac will offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules. Complementing these services are dedicated teams in pack design & artwork management and in-house tooling fabrication. Significant warehousing in ambient, refrigerated and controlled drug storage completes the services offering.

Graeme McBurney, President & Managing Director, Almac Pharma Services said, “We are delighted to be able to invest in new facilities and establish operations in the US. With the alignment of our packaging processes at both our UK and US sites, we offer the highest levels of customer service and continuity of supply, through a flexible and quality lead operation”.

Notes to Editors

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Almac Boosts Capacity and Productivity with Acquisition of New Encapsulation Equipment

admin — Tue, 28 Feb 2012 09:12:20 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, has addressed a surge in clinical outsourcing by acquiring two new pieces of encapsulation equipment at their North American headquarters in Souderton, PA. The Bosch GKF 702 capsule filler with integrated KKE 1700 checkweigher comes as a significant investment for the company close to the one year anniversary of the US headquarters’ grand opening.

The acquisition gives added value to the already impressive array of over-encapsulation capabilities offered by the global service provider as part of a complete clinical supply chain management portfolio. The Bosch cGMP-compliant system is able to produce 42,000 capsules per hour compared to the 2,700-4,500 output of Almac’s current machine in the United States. Further capabilities of the new equipment include powder, pellet, tablet, and placebo fill as well as multi-fill. The addition now creates balance between Almac’s EU and US sites by providing the same capacity to handle large and smaller scale projects simultaneously.

“This level of investment in encapsulation technology allows us to expand our capacity within our core services and shows our commitment to our clients,” says Dan Megill, Director of Operations at Almac. “Bosch was chosen by Almac because they are a leader in capsule filling and weighing equipment with a variety of options. We are extremely pleased with this acquisition and expect it to contribute greatly to Almac’s overall productivity.”

The KKE 1700 checkweighing machinery strengthens the acquisition by offering comprehensive documentation of the production batches, optimal pharmaceutical security, and a high degree of productivity.

The GKF 702 with its upgraded performance builds on the success of the previous GKF 701 model and the machine offers many advantages for research and development. The machine’s modular design offers the possibility to retrofit any future filling needs and all new filling stations currently in development will be compatible with this machine type.

For more information on Almac’s service capabilities, visit almacgroup.com. Further information about Bosch Packaging Technology is available online at www.bosch.com and www.bosch-press.com.

Notes to Editors

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Almac Responds to Alexion’s Request for Rapid Packaging and Distribution During Public Health Crisis in Germany

admin — Mon, 21 Nov 2011 09:20:30 +0000

Almac, a leading provider of contract services to the global Pharmaceutical and Biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris® (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

Background

Beginning in May and lasting through the summer, Germany experienced a historically large outbreak of food-borne E. coli infection, which resulted in more than 800 cases of STEC-HUS (Shiga-toxin producing E. coli hemolytic uremic syndrome), an ultra-rare and life-threatening complication of the infection. As the crisis grew, Alexion initiated an access program to provide Soliris free of charge in response to requests from physicians treating patients with STEC-HUS. Subsequently, Alexion commenced a clinical study with Soliris in STEC-HUS patients, in collaboration with the German healthcare authorities and leading physicians.

Although Alexion continuously maintains more than 18 months of Soliris inventory in addition to its two manufacturing sources, the need for Soliris specifically packaged for use at various centers in Germany was greater than the normal use of Soliris for patients with paroxysmal nocturnal hemoglobinuria (PNH) in that country. Alexion contacted Almac for assistance in delivering the drug, packaged and labeled, to the EU, and requested an extremely short turnaround time to package and distribute their drug product. Soliris is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare and life-threatening blood disorder, in the U.S., European Union, Japan and other countries. Soliris is also approved for the treatment of patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare and life-threatening genetic disorder, in the United States. The German physicians were using Soliris in STEC-HUS on an investigational basis. The study evaluating the safety and efficacy of Soliris for the treatment of patients with STEC-HUS is ongoing.

“Almac understood the importance of meeting this critical timeline to Alexion and ultimately the German patients. Because of this, the project had visibility to the highest levels at Almac and meetings were held daily to ensure that nothing was missed or allowed to cause delay,” said Donna Christopher, VP of Operations at Almac’s Durham, North Carolina facility. “This was a very gratifying collaboration for Almac to be involved in, as we were able to make an immediate impact to a highly publicized public health crisis. This was satisfying to everyone who worked on this project.”

Almac’s overall approach was to quickly process (within 48 hours) the current commercial Soliris^® drug product stock held at Craigavon, UK (licensed for the treatment of PNH – paroxysmal nocturnal hemoglobinuria) on a Named Patient basis to German physicians to treat this life threatening condition. When the initial urgent requirement was met, Almac was then able to scale up the packaging and distribution of the clinical trial product.

The product was successfully delivered to patients in the time requested due to the careful planning and constant communication of all parties involved. “Almac was very pleased to be able to deliver the drug to Germany within the timeframe,” said Robert Dunlop, President of Almac Clinical Services. “Given the nature of our industry, there are occasions when we all have to pull together to address a critical patient need. The supply of Soliris^® to patients in Germany is a great example of what can be achieved when different stakeholders combine their respective strengths for the common good.”

For more information on Almac’s capabilities, please visit almacgroup.com or email info@almacgroup.com. More information on Alexion is available at www.alexionpharma.com.

Notes to Editors About Almac Group

About Almac

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

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Almac announces expansion to its commercial facility with the addition of increased storage capacity for biologic products

admin — Fri, 25 Mar 2011 11:41:12 +0000

In response to increased client demand for cold and dedicated frozen storage capacity for biopharmaceuticals, Almac’s Pharma Services business unit has expanded its commercial facilities to include an additional 6124 sq ft of cold and frozen storage.

This is a joint investment with a commercial client, for which Almac provides central EU importation, warehousing and distribution services. This includes dedicated -70°C, -20°C and 2-8°C storage for drug antibody, drug linker, bulk drug substance, placebo and filled vials, coupled to before and after distribution to various global processing facilities.

In preparation for the successful commercialisation of the drug product, 20 additional dedicated freezer units have been added to the existing 10, for the storage of the monoclonal antibody and bulk drug substance products.

Strengthening Almac’s EU product launch services, the expansion has also resulted in increased floor space facilitating shipping system configuration for bulk drug product and for direct to pharmacy supply of niche orphan drug products.

David Downey, Vice President, Commercial Operations comments “It is a pleasure to be able to expand our scope of services through this shared investment. Our ability to ensure all necessary preparations are made for this important commercial launch, positions Almac well within this growing biopharmaceutical sector”.

About Almac

The Almac Group offers 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 almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff has now transferred to Almac’s new $120m North American Headquarters which is now fully operational.

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

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Almac adds Late Stage Customisation Suite to assist Orphan Drug / Niche Product Launches into Europe

admin — Fri, 26 Nov 2010 14:09:35 +0000

With a growing requirement to support our clients with their EU product launches, reduce stock holdings and provide greater flexibility with regional packs, Almac has added an additional dedicated Late Stage Customisation Suite to the company’s commercial facilities.

Mark English, Distribution Manager at Almac explains, “Late stage customisation involves working with the client, understanding their country launch requirements to develop an EU regional supply strategy. Grouping countries by language allowing for multilanguage packs to service multiple markets, with country specific information added at point of despatch, provides significant cost advantages. Working with products that are manufactured in very low volumes at, often, a very high cost means that solutions to minimise stock holding are of particular benefit”.

Historically the countries grouped together tended to be based on geographical proximity to ensure that distribution to the end user was as short as possible. However with modern shipping methods this is no longer necessarily the case. The main factors now tend to be which countries share a common language i.e. UK/Ireland and Germany/Austria and having at least one of the “Big 5” (Germany, France, Spain, Italy & the UK) in each regional pack, meaning that smaller markets can be served when required without committing any stock for orders that may never arise.

Assembling regional packs results in one pack being available for as many as 5 markets, as country specific information is applied to the ‘Blue Box’ area as orders are received direct from pharmacies or hospitals. The addition of the dedicated Late Stage Customisation Suite gives Almac the flexibility to process these orders immediately ensuring just-in-time delivery.

David Downey, VP Commercial Operations of Almac explains “With our client partners, we have successfully launched many high-value, orphan drug / niche products into the European market, hitting launch timelines, and maximising product flexibility to supply multiple markets. Utilising our integrated pharmaceutical and distribution services we can provide a seamless transfer of product and services to the end-user.”

Contact:

Tristan Jervis

De Facto Communications

Tel: + 44 207 8613019

E-mail@: t.jervis@defcato.com

About Almac Group

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

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

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

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Almac completes £2 million client sponsored investment expanding commercial sacheting capacity

admin — Mon, 14 Jun 2010 16:57:17 +0000

Meeting our client partner’s commercial need for additional sachet capacity, Almac completes a £2 million investment programme.

Almac Pharma Services have today announced the completion of a client sponsored capital investment of £2 million at the company’s commercial facilities at the Group’s headquarters in Craigavon, Northern Ireland.

Annualised output will be in excess of 120 million sachets, split across various packed formats.

Geoff Sloan, VP Manufacturing Operations of Almac Pharma Services said: “This investment has allowed our client to quickly meet growing demand for one of their key future products. Utilising Almac’s technical and project management expertise to deliver a complex engineering solution to an aggressive project timeline will assist our client in securing the market for this strongly performing product.”

Graeme McBurney, President and M.D of Almac Pharma Services said: “This level of investment demonstrates our commitment to building long term, strategic relationships with our client partners.”

-End-

Contact

Tania Davis

Almac Pharma Services

Tania.davis@almacgroup.com

Tel: +44 2838 363363

Tristan Jervis

DeFacto

T.Jervis@Defacto.com

Tel: + 44 2078 613019

About Almac Group

The company employs over 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m 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

The post Almac completes £2 million client sponsored investment expanding commercial sacheting capacity appeared first on Almac.

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 Announce Potent Containment Capabilities

admin — Thu, 15 Oct 2009 10:50:16 +0000

Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses, Almac has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in our Product Development facility.

Our in-house engineered containment solutions employ rigid & flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.

We have the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.

Almac is dedicated to continually developing processes and technologies, to remain at the forefront of innovation and to offer a comprehensive outsourcing service to our clients.

– ENDS –

Contact

Tania Davis

Almac Pharma Services

T: +44 (0) 28 3836 3363

pharmaservices@almacgroup.com

About Almac Group:

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $112m North American Headquarters in PA started in July 2008 and will be completed in 2010.

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

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Almac Extends Commercial Support Services to add Third Party Logistics “3PL”

admin — Wed, 14 Oct 2009 17:37:53 +0000

Having successfully supported our clients through numerous EU product launches and in response to their requirements, Almac is expanding its Commercial Support Services to offer a fully integrated solution to both existing and new “niche” pharmaceutical products. Almac’s ‘one-stop-shop’ model offers a comprehensive range of supply chain solutions under the management of its dedicated product supply team.

Clients seeking EU import analysis, country/region-specific labeling and packaging services, QP market release, order and financial management and direct distribution to the end-user (hospital, clinic or pharmacy), can now look to Almac for a tailored solution to fulfill their needs.

Ordering online, via a secure 24/7 web based server or through dedicated email, multi-lingual telephone or fax based channels, your patient needs can now be met by the same CMO responsible for your drug product packaging and release.

Eliminating the need for multiple vendors removes unnecessary complexity; excess handling and transportation; and minimizes risk from your commercial launch. Managed from start to finish, Almac allows you to benefit from a more reliable, timely and cost-efficient supply chain service.

– ENDS –

Contact

Tania Davis

Almac Pharma Services

T: +44 (0) 28 3836 3363

pharmaservices@almacgroup.com

About Almac Group:

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

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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 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 and Middlebrook Pharmaceuticals discuss their successful partnership in Tablets and Capsules

admin — Tue, 02 Jun 2009 17:21:48 +0000

Almac and Middlebrook Pharmaceuticals, Inc. discuss their partnership in the May edition of Tablets and Capsules. Within the article, Don Treacy (Snr VP of Development and Manufacturing Operations, Middlebrook) discusses the development of the first and only, once-daily amoxicillin treatment, Moxatag, and the steps involved in developing a successful, strategic partnership with Almac to ensure a successful launch of Moxatag.

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Almac Pharma Services Retained by MiddleBrook Pharmaceuticals to Produce Physician Samples of MOXATAG

admin — Thu, 05 Feb 2009 17:24:43 +0000

The first and only FDA-approved once-daily amoxicillin will be promoted to health care professionals nationwide beginning March 2009

Almac Pharma Services, a product development and commercial manufacture partner to the international pharmaceutical industry, today announced that MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company committed to developing anti-infective products that fulfill unmet medical needs, has retained Almac to provide packaging services for physician samples of MOXATAG (amoxicillin extended-release) Tablets, 775 mg. Almac Pharma Services will work closely with MiddleBrook’s chosen commercial manufacturer, STADA Production Ireland®.

“MOXATAG samples will be a key element of our nationwide launch to health care professionals in March 2009,” MiddleBrook President and CEO John Thievon said. “Physician samples allow doctors to quickly initiate treatment in conjunction with a patient’s office visit. Almac will provide services integral to the MOXATAG launch, and we’re pleased to have Almac as a partner.”

Almac Pharma Services Vice President of Commercial Operations David Downey said, “Almac is delighted to be working with MiddleBrook to produce sample packs in support of the MOXATAG product launch.”

About Almac:

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

The company has over 2,200 employees and is headquartered in Craigavon, Northern Ireland. U.S. operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100 million North American Headquarters started in July 2008 and is expected to be completed 2010.

Almac Pharma Services is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries has over 30 years’ experience in the development and manufacture of solid, oral dosage products. Capabilities include formulation and analytical development, clinical and commercial-scale drug product manufacture, primary and secondary packaging, EU import testing, QP release and supply chain management. To find out more about Almac visit almacgroup.com.

About MiddleBrook Pharmaceuticals:

MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) is a pharmaceutical company focused on developing and commercializing anti-infective products that fulfill unmet medical needs. We are currently developing a portfolio of anti-infective products utilizing our proprietary, once-a-day pulsatile delivery technology called Pulsys. Our near-term corporate strategy is to improve dosing regimens and/or frequency of dosing which we believe will result in improved patient dosing convenience and compliance for antibiotics that have been used and trusted by physicians and patients for decades. The Company currently markets the Keflex brand of cephalexin and has received regulatory approval for Moxatag – the first and only once-daily amoxicillin product approved for marketing in the U.S. For more information about MiddleBrook, please visit www.middlebrookpharma.com.

About Moxatag:

Moxatag (amoxicillin extended-release) Tablets, 775mg, is a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release component and two delayed-release components. The three components of Moxatag are combined in a specific ratio to prolong the release of amoxicillin compared to immediate-release amoxicillin. Moxatag is intended to provide a lower treatment dose, once- daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. For more information about Moxatag, please visit www.middlebrookpharma.com.

– ENDS –

For further information contact:

David Downey

Vice President of Commercial Operations – Almac Pharma Services

T: +44 (0) 28 3836 3363 (Europe)

T: +1 (610) 666 9500 (US)

F: +44 (0) 28 3836 3300

E: david.downey@almacgroup.com

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Almac Pharma Services Expands it Commercial Support Capability

admin — Thu, 20 Mar 2008 11:49:30 +0000

Due to increasing demand for commercial support services in Europe from non-EU based manufacturers, Almac Pharma Services has completed a series of investments that will strengthen its capabilities in a growing service area.

As new projects have been secured, the company has expanded its modular refrigerated rand frozen storage facilities, enabling it to take more temperature sensitive drug products into its commercial portfolio.

The company’s ability to offer custom storage, labelling, packing and distribution services from brite stock inventories has also been enhanced through the acquisition of additional bespoke vial/ampoule labelling equipment.

Complementing this expanded capability, the company is at late stage development of an e-portal that will improve material handling at all stages of the supply chain and offer clients, secure, online access to vital supply data thus improving decision-making and service levels.

Almac Pharma Services’ President & M.D, Graeme McBurney commented, “These investments add to the already significant “single site” service advantages available within the company.” He said, “Reliable and experienced providers of all these services are very difficult to secure, yet the services are vital to every successful product launch in Europe by niche and speciality Pharma companies”.

About Almac Pharma Services

Almac Pharma Services, a division of the Almac Group, is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries. We have over 30 years’ experience in the development and manufacture of solid, oral dosage products. Our capabilities include formulation and analytical development, clinical and commercial-scale drug product manufacture, primary and secondary packaging and global supply chain management.

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 world leaders in the pharmaceutical and biotech sectors. The company has 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit almacgroup.com.

Contact:

Jim McGibbon

T: +1 (610) 666 9500 (US) & +44 (0)28 3833 2200 (Europe)

E: jim.mcgibbon@almacgroup.com or pharmaservices@almacgroup.com

W: almacgroup.com

The post Almac Pharma Services Expands it Commercial Support Capability appeared first on Almac.

Almac appoints new VP Commercial Operations for Pharma Services

admin — Mon, 17 Mar 2008 17:51:40 +0000

Almac has appointed David Downey as the new VP for Commercial Operations for the Group’s Pharma Services division. David will be based at the Group’s headquarters in Craigavon, Northern Ireland and will have responsibility for Client Services and Business Development in Pharma Services.

David has worked in the pharmaceutical industry for the last twelve years, most recently for Patheon where since 2002 he was based in Italy, returning to the UK in 2007 as Business Director of Patheon’s UK and France operations. David also held various roles in QA, Validation, Production and Project Management with Quintiles, Medeva (now Novartis) and Scherer DDS (now Catalent).

David graduated with a BSc (Hons) in Marine Biology from the University of London and an MSc in Environmental Toxicology from Reading University.

Ends

Contact

Carl Whyte

Stakeholder Communications

02890 339949

The post Almac appoints new VP Commercial Operations for Pharma Services appeared first on Almac.

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

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

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 and Provention Bio, Inc Celebrate Rapid Launch of TZIELD™ (teplizumab-mzwv)

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 Clinical Supply and Commercial Solutions Support Agios’ Road to FDA Approval

Almac Pharma Services Expands its Unique Ultra-Low Temperature Solutions for Advanced Therapy Medicinal Products

Tailored service enables processing and QP release within 20 hours

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

Almac Group to Host EU Product Launch Workshop Series in California and Washington States

Almac Group Recognised with Six Life Science Leader CMO Awards

Almac Group Announces Successful HPRA Inspection at its European Campus

Almac Group Appoints Three Vice Presidents

Almac Group Expands US Specialised Commercial Packaging Capabilities

Almac Group announces further expansion at its European Campus in Dundalk

Almac Group Announces Successful MHRA Inspection at Charnwood Facilities

Petya ransomware attack – Almac update

Almac to Exclusively Share Global Expertise in EU Product Launch Workshop

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

Almac Group’s Integrated Development to Commercialisation Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product

Almac Group’s Rapid Launch Services Support U.S. Approval of Intercept Pharmaceutical’s First Commercial Orphan Drug Product

Almac Group Launches US Serialisation Solution in Partnership with Optel Vision

Almac Wins Three CMO Leadership Awards

Almac Group Addresses Industry Demand for Multiparticulate Drug Products with Scalable Fluid Bed and Encapsulation Technologies

Almac Group’s Integrated CMC Services Support US Approval of Wellstat Therapeutics’ First Commercial Orphan Drug Product

Almac Further Enhance 3rd Party Logistics Commercial Support Services for Niche / Orphan Drugs

Almac launches US commercial packaging operations with successful FDA inspection and new client partnership

Almac expands UK commercial capacity with the acquisition of new blistering technology

Almac installs Uhlmann Blister Line in new US Commercial Packaging Facility

Almac expands in US with addition of Commercial Packaging facility in Audubon

Almac Boosts Capacity and Productivity with Acquisition of New Encapsulation Equipment

Almac Responds to Alexion’s Request for Rapid Packaging and Distribution During Public Health Crisis in Germany

Almac announces expansion to its commercial facility with the addition of increased storage capacity for biologic products

Almac adds Late Stage Customisation Suite to assist Orphan Drug / Niche Product Launches into Europe

Almac completes £2 million client sponsored investment expanding commercial sacheting capacity

Almac completes its expansion plan to Pharma Services facilities

Almac Announce Potent Containment Capabilities

Almac Extends Commercial Support Services to add Third Party Logistics “3PL”

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

Almac and Middlebrook Pharmaceuticals discuss their successful partnership in Tablets and Capsules

Almac Pharma Services Retained by MiddleBrook Pharmaceuticals to Produce Physician Samples of MOXATAG

Almac Pharma Services Expands it Commercial Support Capability

Almac appoints new VP Commercial Operations for Pharma Services