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Almac Launches Biologics Testing Services

New services include GMP lot release and stability testing to support drug substance and drug product programs for biologics and biosimilars.

By: Contract Pharma

Contract Pharma Staff

Almac Sciences is expanding its existing suite of analytical solutions to include biologics testing. This new offering follows the company’s expansion of its Irish lab in 2019 where the company now provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programs adhering to industry regulations including FDA, EMA and PMDA, under GMP standards
 
Almac’s new services include GMP lot release and stability testing to support clients’ drug substance and drug product programs for both novel biologics and biosimilars; fit-for-purpose analytical method development / phase-appropriate method validation; raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.
 
The expansion of biologics analytical testing solutions complements analytical services already offered from Athlone as well as its global headquarter campus in the UK and facility in Pennsylvania, North America. This investment will include an increase to its existing workforce of 150 to meet continued client demand. Additionally, two key positions have been appointed to provide additional leadership and site management for the expanded offering.
 
Simon Cocks has been appointed as Athlone Site Manager and, with a PhD in Analytical Chemistry from Loughborough University, brings over 25 years’ industry experience to the role. Prior to joining Almac, he managed multifunctional/multisite technical and support teams within both the CRO/CDMO and pharmaceutical industries.
 
Pavan Kumar Kunala has been recruited as Biopharma Lab Manager, also based at Almac’s Athlone facility.  Pavan has a strong background in the field of analytical development for biologics, with over a decade of experience. In his previous roles at Intas Biopharmaceuticals and Pfizer, he was responsible for leading a team of scientists to support analytical method development, validation and overall CMC strategy for the advancement of early, late and commercial biologics.
 
Amid the current COVID-19 pandemic, Almac Sciences is now offering virtual auditing solution for clients on request.
 

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