- WuXi Biologics has received European Medicines Agency (EMA) approval for its Dundalk, Ireland site as a commercial manufacturing facility for a client’s innovative biologic.
- The approval marks the site’s first commercial launch, following full GMP authorisation in 2024.
WuXi Biologics, a global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that the EMA has approved its Dundalk facility in Ireland for commercial production of a biologic medicine. This is the latest in a series of regulatory authorisations, with the company’s other facilities receiving EMA and FDA approvals for the same product since 2023.
The approval represents the first commercial launch from WuXi Biologics’ Ireland site. The facility was granted GMP authorisation by the Irish Health Products Regulatory Authority (HPRA) in 2024 and was recognised with the ISPE Facility of the Year Award in 2023. It houses 6,000L perfusion and 48,000L fed-batch capacity and has successfully completed large-scale qualification runs, including a 16,000L process using four 4,000L single-use bioreactors.
Dr. Chris Chen, CEO of WuXi Biologics, said: “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.”
The EMA clearance strengthens the company’s Global Dual Sourcing Strategy, which deploys multiple qualified sites for the same product family, enhancing supply resilience and regional access.
WuXi Biologics reported that by the end of 2024, it had passed 42 regulatory inspections, including 22 by the EMA and FDA, and had secured 97 licence approvals worldwide. The company said its unified quality management system underpins its 100% success rate in inspections, ensuring site equivalency and compliance with international standards.
