WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its Biosafety Testing Center in Suzhou has successfully passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with zero critical findings. This marks 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. The EMA inspection focused on biosafety quality control testing for cell banks and commercial unprocessed bulk associated with these products.

GMP-compliant biosafety quality control testing of commercial unprocessed bulk is a key part of pre-license inspections for biologics seeking marketing authorization in the European Union and remains a focus in routine inspections of commercial products. The four-day inspection covered areas such as quality management, facilities and equipment, testing methods, standard operating procedures, computerized systems and personnel. The Suzhou facility's quality system, infrastructure, technical capabilities, data integrity and organizational management were highly recognized by the EMA.

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."

WuXi Biologics' Biosafety Testing Center has two facilities in Suzhou and Shanghai, offering comprehensive services including cell bank characterization for CHO, HEK293, and E. coli expression systems, diverse biologics biosafety testing, GMP-compliant release testing for commercial products, and GLP-compliant viral clearance studies supported by high-quality in-house virus production platform. As of December 2025, WuXi Biologics' Biosafety Testing Center has successfully enabled over 1,700 IND or BLA applications. Its high-quality system and technical capabilities have been widely recognized by global regulatory authorities and clients.

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.