Contract development and manufacturing organization (CDMO) WuXi Biologics announced this week that its Dundalk, Ireland facility has received European Medicines Agency (EMA) approval as a commercial manufacturing site for a global client's innovative biologic. This milestone represents the first commercial launch from WuXi Biologics' Ireland site and adds to the company's multiple facilities that 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. "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 Implementation
The EMA approval advances WuXi Biologics' Global Dual Sourcing Strategy, an initiative that deploys multiple qualified manufacturing sites worldwide for the same product family to enhance regional access for patients. With this 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.
The Dundalk facility is now positioned as a key manufacturing hub in WuXi Biologics' global network, capable of supplying the undisclosed innovative biologic across multiple regions as part of the company's multitude of sites working on the same product family.
Advanced Manufacturing Capabilities
The Dundalk facility boasts significant manufacturing capabilities, featuring advanced 6,000-liter perfusion and 48,000-liter fed-batch capacity. The site 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 — representing one of the largest cell culture processes using single-use technology worldwide.
The facility's recognition extends beyond regulatory approval, having received the ISPE Facility of the Year Award (FOYA) in 2023. Following this recognition, the site received full GMP authorization from the Irish Health Products Regulatory Authority (HPRA) in 2024, paving the way for the recent EMA commercial manufacturing approval.
Regulatory Excellence Track Record
WuXi Biologics maintains exceptional regulatory compliance across its global operations. As of the end of 2024, the company has successfully passed 42 regulatory inspections — including 22 by the EMA and FDA — and secured 97 license approvals from agencies worldwide. The company 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 across WuXi Biologics' global network.
Broader Manufacturing Expansion
The Ireland facility approval comes amid broader expansion efforts by WuXi Biologics and its subsidiaries. Recently, subsidiary WuXi XDC made large-scale manufacturing investments throughout Asia, unveiling its GMP-approved DP3 facility in China earlier this month, expanding the entire site's capacity to up to 15 million vials per year. In June, the subsidiary completed construction of a bioconjugation site in Singapore.
Additionally, earlier this year WuXi Biologics signed an asset purchase agreement for Merck to acquire all assets of the WuXi Vaccines manufacturing facility, also located in Dundalk, Ireland. The $500 million investment secures an over 15,000 square-meter facility with more than 150 staff, capable of both drug substance and drug product manufacturing.
As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing, excluding COVID CMO projects. The company operates with over 12,000 skilled employees across China, the United States, Ireland, Germany, and Singapore.
