WuXi Biologics (Suzhou) Co., Ltd. has successfully passed its first GMP inspection by the European Medicines Agency (EMA), with no critical findings. This is one of the largest biosafety testing laboratories globally providing critical testing support for the global biologics industry.
 
The comprehensive inspection included areas directly related to biosafety testing of a client’s product, as well as WuXi Biologics (Suzhou)’s entire quality system, management system, related instrumentation and equipment. Upon passing the inspection, WuXi Biologics (Suzhou) will be one of a few third-party biosafety testing providers in the Asia-Pacific region to be EU certified, which greatly improves the company’s recognition from drug regulatory agencies and the reliability of its testing services for clients. This also marks another milestone following WuXi Biologics’ first cGMP biologics drug substance facility, first cGMP biologics drug product facility and first cGMP cell banking facility in China, all approved by the EMA.
 
“We are excited about this inspection result, which again showcases our global premier quality services,” said Dr. Chris Chen, chief executive officer, WuXi Biologics. “WuXi Biologics will continue to enable our global partners in order to provide more high quality biologics to benefit patients worldwide.”