SUZHOU, China, August 2, 2021 – WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, it has once again received a European Medicines Agency (EMA) GMP certificate for the Biosafety Testing facility in Suzhou. This certificate demonstrates WuXi Biologics’ compliance to global cGMP biosafety testing standards and regulatory guidelines.
This additional EMA GMP certificate was issued following a remote inspection conducted by Poland’s Chief Pharmaceutical Inspectorate in April 2021. The comprehensive inspection covered not only the Quality Control (QC) testing of a Master Cell Bank (MCB) and Working Cell Bank (WCB) used for the production of an innovative biological product from a global partner, but also the facility’s entire quality system. The inspection was conducted in response to the positive scientific opinion issued by the EMA’s Committee for Medicinal Products (CHMP) on the aforementioned biological product.
Dr. Chris Chen, CEO of WuXi Biologics, commented, “The second EMA certificate is the solid proof of our world-class quality system as well as the technology platforms utilized at our Suzhou facility. However, continuous improvement is the foundation of our organization and thus we will continue to advance our capabilities and quality systems to further enable our global partners to develop novel biotherapeutics.”
WuXi Biologics Biosafety Testing team offers cell line characterization and adventitious agent testing for the QC release of cell banks, unprocessed bulk (UPB) lots and raw materials. The team also conducts viral clearance and inactivation studies per global regulatory guidelines. Since 2015, WuXi Biologics Biosafety Testing team has instituted ISO (CNAS), and CMA-certified laboratories in Suzhou, China and established a solid reputation in the industry for its biosafety services as confirmed through regulatory inspections from the EMA, China’s National Medical Product Administration (NMPA), and over 300 quality audits from global clients. As one of the largest global biosafety testing providers, the WuXi Biologics Biosafety Testing team has an outstanding execution and compliance track record as demonstrated by zero rejections from over 500 biosafety-related testing studies submitted to regulatory agencies 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 March 22, 2021) a total of 361 integrated projects: 190 in pre-clinical development; 137 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 2 in commercial manufacturing. With a total estimated capacity at around 430,000 liters for biopharmaceutical production planned by 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will 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.