WuXi Biologics announces 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.
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 authorisation also 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 6000 L perfusion and 48,000 L 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 L scale by combining four 4000 L 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.