WuXi Biologics Ireland site gets EMA approval for commercial biologics manufacturing

WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO) headquartered in China, said its Dundalk, Ireland facility has received approval from the European Medicines Agency (EMA) as a commercial manufacturing site for a client’s biologic.

The company said the authorization marks the first commercial launch of a biologic from its Ireland site, which received full GMP clearance from the Irish Health Products Regulatory Authority in 2024. The facility includes 6,000 liters of perfusion capacity and 48,000 liters of fed-batch capacity, making it a key hub in WuXi Biologics’ global network.

“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,” Chris Chen, CEO of WuXi Biologics, said in a statement. 

The Dundalk site achieved a 100% success rate in multiple large-scale Process Performance Qualification runs, according to the company, including a 16,000-liter process that combined four 4,000-liter single-use bioreactors — one of the largest of its kind.

WuXi Biologics said the EMA authorization builds on its Global Dual Sourcing Strategy, which designates multiple qualified sites worldwide to support the same product family and expand regional access. The company has passed 42 regulatory inspections worldwide, including 22 by the EMA and FDA, and holds 97 license approvals as of the end of 2024.