WuXi Biologics Suzhou Center Passes EMA GMP Inspection

WuXi Biologics’ Biosafety Testing Center in Suzhou has successfully passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with zero critical findings—marking the fourth time the facility has successfully received EMA GMP certificate.

The inspection supported the European Union marketing authorization application for a total of 19 biologics from 13 clients, with the majority developed and manufactured on WuXi Biologics’ integrated platform. These products span a range of biologics modalities, including antibodies, enzymes, and fusion proteins.

Dr. Chris Chen, CEO of WuXi Biologics, commented: “From preliminary safety validation at cell bank and harvest stages to final quality control at commercial batch release, biosafety testing spans critical stages across the entire lifecycle of biologics, ensuring compliance with rigorous regulatory requirements from development through commercialization. We remain committed to maintaining a high-quality system aligned with global GMP standards as a cornerstone to ensure product quality. This capability is consistently demonstrated and implemented across our global network, reflecting our long-standing commitment to enabling our partners and ultimately benefiting patients worldwide.”

In additional to EMA, WuXi Biologics’ Biosafety Testing Center has received multiple recognitions from other global regulatory authorities. It has successfully completed remote interactive evaluation by the U.S. Food and Drug Administration (FDA), and has passed inspections by China National Accreditation Service for Conformity Assessment (CNAS), National Medical Products Administration (NMPA), Health Canada (HC), the Therapeutic Goods Administration (TGA) of Australia, and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, as well as more than 510 quality audits conducted by global clients.

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