WuXi Biologics Ireland Facility Receives EMA Approval for Commercial Manufacturing of Innovative Biologic
WuXi Biologics Ireland Facility Receives EMA Approval for Commercial Manufacturing of Innovative Biologic |
| [18-August-2025] |
- Further demonstrates WuXi Biologics' Global Dual Sourcing strategy in commercial manufacturing - Underscores the excellence of WuXi Biologics' world-class quality system across its global network DUNDALK, Ireland, Aug. 18, 2025 /PRNewswire/ -- WuXi Biologics (Stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its Dundalk, Ireland facility has been approved by the European Medicines Agency (EMA) as a commercial manufacturing site for a global client's innovative biologic. This approval adds to WuXi Biologics' multiple facilities, which have received EMA and FDA approvals for commercial manufacturing of the same product since 2023. Dr. Chris Chen, CEO of WuXi Biologics, commented, "This EMA approval marks another significant milestone in WuXi Biologics' journey and our ability to meet client needs, fully demonstrating the value of our Global Dual Sourcing Strategy in offering robust and flexible manufacturing solutions across multiple geographies, while maintaining a consistent track record of regulatory approvals. We remain committed to delivering high-quality, life-saving treatments for global clients, bringing meaningful benefits to patients around the world." Global Dual Sourcing Strategy in Action WuXi Biologics' Global Dual Sourcing Strategy deploys multiple qualified manufacturing sites worldwide for the same product family and enhances regional access for patients. With this EMA approval, WuXi Biologics now operates multiple approved sites across different regions for this innovative biologic, reinforcing the company's capability to deliver regulatory-compliant manufacturing services from any site within its global network. First Commercial Launch from WuXi Biologics' Ireland Site The EMA authorization also represents the first commercial launch of a biologic from WuXi Biologics' Ireland site, following the facility's full GMP authorization from the Irish Health Products Regulatory Authority (HPRA) in 2024. The site, recognized with the ISPE Facility of the Year Award (FOYA) in 2023, features advanced 6,000L perfusion and 48,000L fed-batch capacity, and now serves as a key manufacturing hub in WuXi Biologics' global network. It delivered a 100% success rate across multiple large-scale Process Performance Qualification (PPQ) runs, including a 16,000-liter scale by combining four 4,000-liter single-use bioreactors — one of the largest cell culture processes using single-use technology worldwide. Global Quality Excellence With 42 regulatory inspections successfully passed — including 22 by the EMA and FDA — and 97 license approvals from agencies worldwide as of the end of 2024, WuXi Biologics maintains a 100% success rate in global regulatory inspections, with no critical findings and zero data integrity issues. This unified quality management system enables seamless technology transfer, site equivalency, and compliance with the highest international standards. 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 December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects). WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain. For more information about WuXi Biologics, please visit: www.wuxibiologics.com. Contacts Business Media
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Company Codes: HongKong:2269,HongKong:2269.HK |
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