WuXi Biologics, a leading global contract research, development and manufacturing organisation (CRDMO), has announced that its Dundalk, Ireland facility has been approved by the European Medicines Agency (EMA) as a commercial manufacturing site for a 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.   

"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,” said Dr. Chris Chen, CEO of WuXi Biologics.

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

Equipped with 6,000L perfusion and 48,000L fed-batch capacity, the Dundalk facility has become a key hub in the company’s global network.

It delivered a 100 percent 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.

As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).