WuXi Biologics Completes GMP Inspection by Health Canada for Drug Substance Facility
WuXi Biologics announced a successful remote GMP inspection by Health Canada for its drug substance facility in Wuxi, with no observations noted. This inspection is part of nearly 20 regulatory assessments conducted by various agencies, including the U.S. FDA and EMA, highlighting WuXi's commitment to quality. CEO Chris Chen emphasized the importance of maintaining global quality standards to facilitate life-saving treatments. The company is involved in 408 integrated projects and aims to enhance its biomanufacturing capacity exceeding 430,000 liters across multiple countries by 2024.
- Successful remote GMP inspection by Health Canada with no observations.
- Comprehensive quality system certified by multiple global regulatory agencies.
- Currently managing 408 integrated projects, indicating strong operational activity.
- Plans to exceed 430,000 liters in biopharmaceutical production capacity by 2024.
- None.
- Successfully completed nearly 20 regulatory inspections in total, including 13 regulatory inspections since the start of 2021
WUXI, China, Oct. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by Health Canada for its drug substance facility (MFG2) in Wuxi city. There were no observations during the inspection, demonstrating that the company's premier quality system is in full compliance with global regulatory requirements.
The comprehensive inspection was conducted by three inspectors and covered the facility's quality processes and entire production system. So far, WuXi Biologics has successfully completed nearly 20 regulatory inspections conducted by eight different agencies including the U.S. FDA, EMA and NMPA, 13 of which were conducted this year.
"We are very proud of successfully completing another regulatory inspection," said Dr. Chris Chen, CEO of WuXi Biologics. "Our world-class quality system being certified by various regulatory agencies in the U.S., EU, China, Japan, Brazil, and Singapore is a strong testament to our commitment to maintaining the highest global quality standards. With those standards as our cornerstone, WuXi Biologics will continue to enable our global partners to provide life-saving treatments quickly and effectively to benefit 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.
The company is currently conducting on behalf of its clients and partners (as of June 30, 2021) a total of 408 integrated projects, including: 212 in pre-clinical development stage; 160 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 4 in commercial manufacturing. With a total estimated capacity exceeding 430,000 liters for biopharmaceutical production planned after 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will continue to provide its biomanufacturing partners with a robust and premier-quality global supply chain network.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation clean biomanufacturing technologies and utilize cleaner energy sources. We have also established an ESG committee led by the CEO to increase efficiency while advancing commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
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SOURCE WuXi Biologics
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