Almac Group secures HPRA certification for biologics testing
December 14, 2022
Health Products Regulatory Authority (HPRA) has certified Almac Sciences Ireland (ASI) facility for testing of biologics after a successful audit
The certification adds to Almac’s existing GMP certificate, renewed in 2022, which covers testing raw materials, small molecules and microbiology. This additional certification enables Almac to perform biologics testing for the determination of product quality attributes throughout the drug development cycle, from development to commercialization.
The analytical testing lab, based in Athlone, Ireland, provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programs adhering to industry regulations including FDA, EMA and HPRA under GMP standards.
Almac’s biologic testing services include GMP lot release and stability testing to support clients’ drug substance and drug product programs for both novel biologics and biosimilars. It also includes 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 addition of this biologics certification complements the well-established range of analytical services already offered from Athlone as well as its global headquarters in Craigavon, UK and Almac’s facility in Pennsylvania, North America.
Dr Pavan Kumar Kunala, Biopharma Lab Manager for Almac Sciences said: “I am delighted that our lab has received this HPRA certification which will enable us to offer enhanced analytical testing services to our clients. With the current landscape of increased growth in biologics post-pandemic, Almac’s service offering for biologics testing reiterates the commitment to provide superior solutions in the advancement of human health.”
Dr Simon Cocks, Site Manager of the Athlone laboratory, added: “Achieving this certification is testament to the commitment of the biologics testing team. 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. We are confident that the addition of this biologics testing certification will continue to strengthen our competitive position in the marketplace.”
About Almac Group
The Almac Group is an established contract development and manufacturing organization 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 commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization which has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the USA and Asia.