WuXi Biologics Biosafety Testing Facility Received Second EMA GMP Certificate

03 August 2021 | Tuesday | News

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.
Image Source : Public Domain

Image Source : Public Domain

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.

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