WuXi Biologics' Suzhou Biosafety Testing Center Earns Fourth EMA GMP Certification, Enabling 19 Biologics for EU Market
核心洞察
WuXi Biologics' Suzhou Biosafety Testing Center received its fourth EMA GMP certification with zero critical findings, following a four-day inspection.
The certification supports EU marketing authorization applications for 19 biologics from 13 clients, spanning antibodies, enzymes, and fusion proteins.
The facility has enabled over 1,700 IND or BLA applications and has been recognized by multiple global regulators including the FDA, NMPA, Health Canada, and PMDA.
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 (搜索) (EMA) with zero critical findings. This marks the fourth time the facility has received an EMA GMP certificate, underscoring the company's sustained compliance with rigorous European regulatory standards.
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.
Regulatory Significance and Inspection Scope
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 including 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."
Comprehensive Biosafety Testing Capabilities
WuXi Biologics' Biosafety Testing Center operates 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 a high-quality in-house virus production platform. As of December 2025, the Biosafety Testing Center has successfully enabled over 1,700 IND or BLA applications.
Global Regulatory Recognition
In addition to the EMA, WuXi Biologics' Biosafety Testing Center has received multiple recognitions from other global regulatory authorities. It has successfully completed a remote interactive evaluation by the U.S. Food and Drug Administration (FDA), and has passed inspections by the 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. The facility has also undergone more than 510 quality audits conducted by global clients.
Company Growth and Portfolio
As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio. The company employs over 13,000 people across China, the United States, Ireland, Germany, and Singapore, and was recently named the "2026 Biologics CDMO of the Year" (Large CDMOs) by Life Science Connect / Outsourced Pharma, as well as the winner of the "2026 Best Contract Development & Manufacturing Organization Award" (ABEA).