In This Article:
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Multiple successful 16,000L PPQ runs highlight that disposable manufacturing can achieve similar performance as traditional stainless reactors
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GMP Authorizations by HPRA demonstrate that new global sites have built strong world-class regulatory and quality system
DUNDALK, Ireland, Dec. 5, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced major accomplishments at its cutting-edge greenfield site in Dundalk, Ireland. The site has successfully completed multiple 16,000-liter Process Performance Qualification (PPQ) runs at its MFG7 drug substance suite. So far, the site has completed two PPQ runs with 100% success rate. In addition, all three manufacturing facilities received GMP approval from the Irish Health Products Regulatory Authority (HPRA) at the same time. These milestones underscore the site's critical role in delivering world-class biomanufacturing solutions across WuXi Biologics global network.
These PPQ runs achieved 16,000-liter scale by combining four 4,000-liter single-use bioreactors, representing one of the largest cell culture processes using single-use technology worldwide. The scale-up was not only innovative and more ESG-friendly, but also demonstrated the company's ability to deliver comparable Cost of Goods (COGS) to traditional large-scale stainless-steel bioreactors up to 20,000L.
The GMP authorization was granted by HPRA following a comprehensive on-site inspection in October 2024, which evaluated the GMP oversight of all data, processes, personnel, manufacturing, storage, and analytical areas across the multi-product facility. The granting of this approval provides WuXi Biologics the opportunity to expand its services to support the unmet needs of patients worldwide and highlights the commitment to comply with standards and legislation allowing it to release clinical and commercial biologics drug substances for global clients, benefiting patients worldwide. To date, the company has passed approximately 40 global regulatory inspections and has received 67 license approvals.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "These accomplishments reflect the remarkable speed, agility, and execution capabilities of our Ireland site while underscoring WuXi Biologics' unwavering commitment to quality, innovation, and sustainability. The successful completion of these milestones strengthens our global manufacturing network and supports our mission to deliver high-quality, life-saving treatments for patients around the world."