WuXi Biologics Marks Major Milestones with Successful 16,000L PPQ Runs and GMP Approval

• WuXi Biologics has successfully completed two 16,000-liter Process Performance Qualification (PPQ) runs at its Dundalk, Ireland, facility.

• The site has received Good Manufacturing Practice (GMP) approval from the Irish Health Products Regulatory Authority (HPRA) for all three of its manufacturing facilities.

WuXi Biologics has announced significant accomplishments at its state-of-the-art greenfield site in Dundalk, Ireland, marking a key milestone in its global biomanufacturing network. The facility has completed multiple successful 16,000-liter Process Performance Qualification (PPQ) runs, with two completed runs achieving a 100% success rate. These runs, which utilized four 4,000-liter single-use bioreactors, represent one of the largest cell culture processes employing single-use technology worldwide. The scale-up process demonstrates not only WuXi’s technical capabilities but also the environmental benefits of adopting more sustainable biomanufacturing methods compared to traditional stainless-steel bioreactors.

In addition to the successful PPQ runs, the Dundalk site has earned Good Manufacturing Practice (GMP) approval from the Irish Health Products Regulatory Authority (HPRA). This approval was granted after a comprehensive on-site inspection in October 2024, ensuring that the site adheres to the highest standards in manufacturing, storage, and analytical practices. As a result, the site is now authorised to produce clinical and commercial biologics drug substances for global clients, further expanding WuXi’s capacity to meet the growing needs of patients worldwide.

The Dundalk facility, operational since March 2022, was developed as a greenfield project and has since become a hub for advanced biomanufacturing. With over 760 skilled employees, the site includes cutting-edge manufacturing suites, such as a 48,000L fed-batch suite and two 6,000L perfusion suites. In 2023, the facility was recognised with the prestigious ISPE Facility of the Year Award for its outstanding design and performance.

WuXi Biologics continues to demonstrate a strong commitment to sustainability, with the Dundalk site holding multiple ISO certifications in energy, environmental management, and occupational safety. These achievements underscore the company’s dedication to innovation and its responsibility to reducing the environmental impact of biomanufacturing.

Dr. Chris Chen, CEO of WuXi Biologics, commented on the milestone: “These accomplishments reflect the remarkable speed, agility, and execution capabilities of our Ireland site while underscoring WuXi Biologics’ unwavering commitment to quality, innovation, and sustainability.”