Suzhou, China, April 14, 2020, WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platform, announced that 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.
Dr. Chris Chen, CEO of WuXi Biologics, commented, “We are excited about this inspection result, which again showcases our global premier quality services. WuXi Biologics will continue to enable our global partners in order to provide more high quality biologics to benefit patients worldwide.”
About WuXi Biologics (Suzhou)
As one of the largest third-party biosafety testing providers in the Asia-pacific region meeting both international standards (USP, EP, JP) and Chinese standards (CN), WuXi Biologics (Suzhou) offers complete CHO cell line characterization testing services, including mycoplasma, retrovirus and general virus screening, along with adventitious virus detection. The company has a state approved BSL-2 biosafety laboratory, with certificates from both the China National Accreditation Service for Conformity Assessment (CNAS) and the China Inspection Body and Laboratory Mandatory Approval (CMA). The company has its own virus bank and technologies used to prepare high-titer viruses, which enable the establishment of a rigorous viral clearance platform. Since 2015, WuXi Biologics (Suzhou) has successfully completed more than 4,000 tests and 300 projects, including more than 20 submissions for the Biologics License Application (BLA).
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. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2019, there were a total of 250 integrated projects, including 121 projects in pre-clinical development stage, 112 projects in early-phase (phase I and II) clinical development, 16 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany and Singapore exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.