WuXi Biologics Achieves Major Milestones at Ireland Site with Multiple 16,000L PPQ Success and HPRA GMP Authorizations

USA - English

• USA - English

• Multiple successful 16,000L PPQ runs highlight that disposable manufacturing can achieve similar performance as traditional stainless reactors
• GMP Authorizations by HPRA demonstrate that new global sites have built strong world-class regulatory and quality system 

DUNDALK, Ireland, Dec. 6, 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."

Since becoming operational in March 2022, WuXi Biologics Ireland site that began as greenfield development in Dundalk has rapidly established itself as a leader in advanced biomanufacturing. With over 760 skilled employees, the facility combines cutting-edge design, sustainability, and scalability. Recognized with the prestigious International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award (FOYA) in 2023, the site features three advanced drug substance manufacturing suites: 6,000L perfusion suite (MFG6.1 and MFG6.2) and a 48,000L fed-batch suite (MFG7).

In addition to its manufacturing capabilities, the site is deeply committed to sustainability, holding ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001). These achievements demonstrate WuXi Biologics' dedication to advancing the industry through innovation and environmental responsibility.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding COVID CMO projects and non-COVID dormant CMO project).

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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