On December 14, 2022 Almac Sciences Ireland, a member of the Almac Group, reported that it has secured certification from the Health Products Regulatory Authority (HPRA) for biologics testing after a successful audit (Press release, Almac, DEC 14, 2022, View Source [SID1234625248]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 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."