WuXi Biologics Suzhou biosafety lab wins fourth EMA GMP certificate enabling 19 EU products
- The Suzhou Biosafety Testing Center received its fourth EMA GMP certificate after a four-day inspection with zero critical findings.
- The inspection supported EU marketing authorization applications for 19 biologics from 13 clients, covering antibodies, enzymes and fusion proteins.
- The centre operates two facilities (Suzhou and Shanghai) and offers cell bank characterisation for CHO, HEK293 and E. coli, GMP release testing and GLP viral clearance studies with in‑house virus production.
- As of December 2025 the Biosafety Testing Center had enabled over 1,700 IND or BLA applications and has completed a remote FDA evaluation plus inspections by CNAS, NMPA, Health Canada, TGA and PMDA and 510+ client audits.
Inspection outcome
WuXi Biologics’ Suzhou Biosafety Testing Center passed a European Medicines Agency GMP inspection with zero critical findings and received its fourth EMA GMP certificate following a four-day audit. The inspection focused on biosafety quality control testing for cell banks and commercial unprocessed bulk.
Scope of the audit
The EMA reviewed quality management, facilities and equipment, testing methods, standard operating procedures, computerized systems and personnel, and recognised the facility’s quality system, infrastructure, technical capabilities, data integrity and organisational management.
Capabilities and regulatory track record
The Biosafety Testing Center operates facilities in Suzhou and Shanghai, providing cell bank characterisation 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 an in‑house virus production platform. As of December 2025 the centre had enabled over 1,700 IND or BLA applications and completed a remote interactive evaluation by the U.S. FDA, inspections by CNAS, NMPA, Health Canada, TGA and PMDA, and more than 510 client quality audits.
Source: WuXi
