Almac Sciences has announced the expansion of its existing suite of analytical solutions to include biologics testing.
This new offering follows the announcement of the company’s expansion of its Irish laboratory in 2019 and from which Almac Sciences 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 the well-established range of analytical services already offered from Athlone as well as its global headquarter campus in the UK and facility in Pennsylvania, North America. Currently employing over 150 scientists globally, this investment will see an increase to its existing workforce to meet continued client demand.
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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. He is a chartered chemist and a Fellow of the Royal Society of Chemistry and brings with him a wealth of knowledge including discovery and development, manufacture, clinical analysis and commercial supply of both small and large molecules in all of the GxP regulatory sectors.
Pavan Kumar Kunala has been recruited as Biopharma Lab Manager, also based at Almac’s Athlone facility. Kunala 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. Kunala holds a M.S. degree in Biological Sciences from Arkansas State University.
“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,” Dr. John Robson, Vice President Analytical Operations at Almac Sciences, said.