GMP Inspection Completed by ANVISA at WuXi Biologics DS facility
Wuxi, CHINA, December 14, 2020 – WuXi Biologics (WuXi Bio) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has completed a five-day GMP inspection of the company’s Drug Substance (DS) facility in Wuxi city for the production of an innovative biological product of a global partner.
This comprehensive inspection was conducted by 5 inspectors and covered the facility’s material management and production system, utility, QC labs as well as related instrumentation and equipment. WuXi Biologics will now submit responses to ANVISA’s inspection report and hopes to obtain GMP certification for the facility in the coming weeks.
Dr. Chris Chen, CEO of WuXi Biologics, said, “Rigorous quality standards are our top priority, and provide a solid foundation for the trust we earn from our clients. Our industry-leading commitment to robust manufacturing and high-quality products, increasing global production capacity and resilient supply chains are more important today than ever. WuXi Biologics will continue to enable our global partners to provide life-saving treatments quickly and effectively to patients worldwide.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 280,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.