18 January 2022 | Tuesday | News
Image Source : Public Domain
WuXi Biologics a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by South Korea's Ministry of Food and Drug Safety for its drug substance facility (MFG2) in Wuxi city. So far, WuXi Biologics has successfully completed 23 regulatory inspections conducted by multiple regulatory agencies including U.S. FDA, EMA and China NMPA.
The comprehensive inspection was conducted by two inspectors and covered the facility's quality processes and entire production system. MFG2 facility implements the pioneering approach of combining multiple 2,000L bioreactor harvests to enable production runs up to 12,000L (i.e. "scale-out" instead of "scale-up"), a strategy that accelerated construction timeline with significantly lower CAPEX investment and higher Return on Investment (ROI), and eliminated challenges brought by traditional scale-up method. All WuXi Biologics' sites across the U.S., Europe and China follow the consistent quality system to ensure high-quality products manufactured for the partners worldwide.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited that we start off the year 2022 by completing the first regulatory inspection successfully. Our world-class quality system certified by major regulatory agencies is a strong testament of the highest global quality standards we adhere to. We are very motivated by the fact that the products manufactured by WuXi Biologics have helped treat patients in multiple countries and regions. WuXi Biologics will continue enabling global partners to deliver life-saving treatments quickly and effectively to the markets, with the aim of benefiting patients worldwide."