WuXi Biologics 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. 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 larger 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 higher international standards.
