Almac Group Launches Biologics Testing Solutions
September 24, 2020
Comprehensive and flexible service accelerates biologics development and approval
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 highly skilled scientists globally, this investment will see an increase to its existing workforce to meet continued client demand. 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.
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. 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. Pavan holds a M.S. degree in Biological Sciences from Arkansas State University.
Dr John Robson, Vice President Analytical Operations at Almac Sciences, commented: “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.
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, 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 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.