WuXi Biologics (HK:2269), a China-based global Contract Research, Development and Manufacturing Organisation (CRDMO), announced on Monday that its facility in Dundalk, Ireland has been approved by the European Medicines Agency (EMA) as a commercial manufacturing site for a global client's innovative biologic.

WuXi Biologics says that this approval adds to its multiple facilities that have received EMA and FDA approvals for commercial manufacturing of the same product since 2023.

Dr Chris Chen, WuXi Biologics CEO, 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."

The EMA authorisation represents the first commercial launch of a biologic from WuXi Biologics' Ireland site, following the facility's full GMP authorisation from the Irish Health Products Regulatory Authority (HPRA) in 2024. The site, recognised 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.