Almac Sciences, a member of the Almac Group, has announced the expansion of its existing suite of analytical solutions to include biologics testing.
At its Irish facility, Almac provides flexible pharmaceutical testing services to support clients’ drug development programs adhering to industry regulations including FDA, EMA and PMDA, under GMP standards.
Almac’s 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 adds to the analytical services already offered from Athlone as well as its global headquarter campus in the UK and facility in Pennsylvania, North America. Currently employing more than 150 scientists globally, this investment will see an increase to its existing workforce. In order to provide additional leadership and site management to ensure the continued execution of this expanded offering, two key posts have been appointed within the last six months.
We are confident the addition of biologics testing solutions will continue to strengthen our competitive position in the marketplace.
Simon Cocks has been appointed as Athlone Site Manager and, with a PhD in Analytical Chemistry from Loughborough University, brings 25 years’ industry experience. 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 more than a decade of experience in the field of analytical development for biologics. 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.
Dr John Robson, Vice President Analytical Operations at Almac Sciences, said: “Biologics have gained huge traction in the last decade and are poised for stronger growth in the coming years with potential to significantly impact patient lives.
”The launch of this service offering furthermore demonstrates Almac’s commitment to offering a best-in-class service to our global client base and in advancing human health. We are confident the addition of biologics testing solutions will continue to strengthen our competitive position in the marketplace.”
Amid the current COVID-19 pandemic, Almac Sciences is now offering virtual auditing solution for clients on request.
