Almac Group secures HPRA certification for biologics testing

Health Products Regulatory Authority (HPRA) has certified Almac Sciences Ireland (ASI) facility for testing of biologics after a successful audit

Almac Sciences Ireland, a member of the Almac Group, has secured certification from the Health Products Regulatory Authority (HPRA) for biologics testing 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 commercialisation.

The analytical testing lab, based in Athlone, Ireland, provides a comprehensive range of flexible pharmaceutical testing services to support clients’ drug development programmes 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 programmes 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...