WUXI BIO(WXXWY) Prnewswire·2024-12-06 00:19Core Insights - WuXi Biologics has successfully completed multiple 16,000-liter Process Performance Qualification (PPQ) runs at its Dundalk, Ireland site, achieving a 100% success rate in two runs, demonstrating the effectiveness of disposable manufacturing compared to traditional stainless reactors [1][2] - The Irish Health Products Regulatory Authority (HPRA) granted GMP approval to all three manufacturing facilities at the site, allowing WuXi Biologics to expand its services globally [3] - The Dundalk facility has been recognized for its advanced biomanufacturing capabilities and sustainability efforts, receiving the ISPE Facility of the Year Award in 2023 [4][5] Manufacturing Capabilities - The site utilizes four 4,000-liter single-use bioreactors to achieve a 16,000-liter scale, marking it as one of the largest cell culture processes using single-use technology globally [2] - WuXi Biologics has established a workforce of over 760 skilled employees at the Dundalk site since its operational start in March 2022 [4] Regulatory and Quality Achievements - The GMP authorization was granted after a comprehensive inspection in October 2024, which evaluated various aspects of the facility's operations [3] - WuXi Biologics has passed approximately 40 global regulatory inspections and received 67 license approvals to date [3] Sustainability Initiatives - The Dundalk facility holds ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001), reflecting the company's commitment to sustainability [5] - WuXi Biologics aims to become an ESG leader in the biologics CRDMO sector, integrating Environmental, Social, and Governance responsibilities into its business strategy [8][9]