WuXi Biologics announced that it has received the Manufacturing License from Japan's Minister of Health, Labor and Welfare (MHLW) for its drug substance facility (MFG2) at Wuxi city, China after a 2-day remote GMP inspection. There was no issue during the inspection, demonstrating the company's strong expertise in addressing global regulatory requirement. WuXi Biologics is conducting the commercial manufacturing of a Covid-19 neutralizing antibody at MFG2 for one of its global partners.
This comprehensive inspection was conducted by 3 inspectors and covered the facility's quality processes and the entire production system. So far, WuXi Biologics has successfully completed nearly 20 regulatory inspections conducted by 7 different agencies including US FDA, EMA, NMPA and 12 inspections since the start of 2021. This successful audit track record demonstrates that the company's premier quality system is in full compliance with global regulatory requirements.
Dr. Chris Chen, CEO of WuXi Biologics said, “Our world-class quality system is the cornerstone to maintain our high sustainable growth and has laid a solid foundation for our global capability expansion to support our customers worldwide. WuXi Biologics will continue to enable global partners to provide life-saving treatments quickly and effectively to benefit patients worldwide.”