WuXi Biologics granted novel authorisation for commercial biologic manufacturing in Ireland

A new approval by the European Medicines Agency (EMA) marks the first commercial launch of a biologic from WuXi Biologics’ manufacturing site in Ireland.

The company’s Dundalk facility was added to Wuxi’s Biologics’ network of facilities when it gained full GMP authorisation last year. Multiple qualified sites have received approvals by the EMA and FDA for commercial manufacturing of the same product since 2023.

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.”

Strengthening the future of biologic manufacturing

The site 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 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 globally.

The first successful run in January 2024 represented a sustainability milestone, Wuxi Biologics noted. Commenting on the success of this run, Dr Chris Chen, CEO of WuXi Biologics remarked it demonstrated “that comparable COGS can be achieved by leveraging more environmental social governance (ESG) friendly single-use technologies.” The inaugural run set the stage for large-scale commercial manufacturing projects at this site, as proven by its latest development.

More recently, Wuxi Biologics announced a new manufacturing development — the initiation of construction for a new site in China, dedicated to advancing next-generation microbial therapies.