WuXi Biologics Successfully Completed Pre-License Inspection and Routine GMP Inspection by U.S. FDA
WuXi Biologics has successfully completed a Pre-License Inspection (PLI) and a routine GMP inspection by the U.S. FDA at its facilities in Wuxi, China. Over 15 working days, nine inspectors evaluated manufacturing, laboratory, and quality systems, confirming compliance with global standards. This represents a significant milestone for WuXi Biologics, enhancing its capacity for late-stage clinical and commercial manufacturing. The company has completed ten inspections since 2017, establishing itself as the only biologics company certified for commercial manufacturing in China.
- Successful completion of Pre-License Inspection and routine GMP inspection by the U.S. FDA.
- Nine inspectors confirmed compliance with global regulatory standards.
- Positioned as a leader in late-stage clinical and commercial manufacturing capabilities.
- None.
WUXI, China, April 6, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has successfully completed both a Pre-License Inspection (PLI) and a routine GMP inspection by the U.S. FDA (FDA). The inspections focused on the two different innovative biologics manufactured at the company's facilities including MFG1, MFG2 and DP1 in Wuxi, China. With an excellent track record during all inspections and audits to date, WuXi Biologics further demonstrated its established premier-quality systems are in compliance with the highest global regulatory standards.
During the 15 working day inspections, 9 inspectors evaluated the manufacturing, raw material, warehousing, laboratory, equipment, utilities and quality systems. Virtual assessment using innovative digital solutions (e.g., due diligence, GMP audits and inspections, persons-in-plant) developed by WuXi Biologics along with a subsequent on-site inspection was conducted on these facilities.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "I'm pleased that the FDA inspections at our Wuxi sites were completed successfully once again, marking yet another milestone in our capability to perform late-stage clinical and commercial manufacturing for our global partners. Recent history of passing regulatory inspections has laid a solid foundation for our continuous expansion of manufacturing capacities and capabilities as we are committed to providing a global dual source supply chain supported by our world-class quality system. Through our robust manufacturing supply network, we will continue to effectively and efficiently bring biologics into the clinic and to the market for our global partners to benefit patients worldwide."
Since 2017, WuXi Biologics has completed ten regulatory inspections conducted by the FDA, EMA and ANVISA. This makes WuXi Biologics the first and, to-date, the only biologics company certificated by these regulatory agencies for commercial manufacturing in China.
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 March 22, 2021, there were a total of 361 integrated projects, including 190 projects in pre-clinical development stage, 137 projects in early-phase (phase I and II) clinical development, 32 projects in late-phase (phase III) development and 2 projects in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore around 430,000 liters after 2024, 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.
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SOURCE WuXi Biologics
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