- WuXi Biologics’ Biosafety Testing Center in Suzhou passed an EMA GMP inspection with zero critical findings, marking the fourth time the facility has received an EMA GMP certificate.
- The inspection supported the European Union marketing authorization applications for 19 biologics from 13 clients and covered biosafety quality control testing activities related to cell banks and commercial unprocessed bulk.
WuXi Biologics announced that its Biosafety Testing Center in Suzhou has successfully passed a Good Manufacturing Practice (GMP) inspection conducted by the European Medicines Agency (EMA) with zero critical findings. The inspection marks the fourth time the facility has received an EMA GMP certificate and supported European Union marketing authorization applications for 19 biologics from 13 clients.
The biologics covered by the inspection included antibodies, enzymes, and fusion proteins. According to the company, most of the products were developed and manufactured using WuXi Biologics’ integrated platform. The EMA review focused on biosafety quality control testing for cell banks and commercial unprocessed bulk associated with these products.
The four-day inspection evaluated areas including quality management, facilities and equipment, testing methods, standard operating procedures, computerized systems, and personnel. WuXi Biologics said the facility’s quality system, infrastructure, technical capabilities, data integrity, and organizational management were recognized during the inspection process.
“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.”
Dr. Chris Chen, CEO of WuXi Biologics
The company’s Biosafety Testing Center operates facilities in Suzhou and Shanghai and provides biosafety testing services for biologics development and commercialization. As of December 2025, WuXi Biologics said the center had supported more than 1,700 IND or BLA applications. The company also noted that the center has completed reviews and inspections by multiple regulatory authorities, including the FDA, NMPA, Health Canada, TGA, PMDA, and CNAS, as well as more than 510 client quality audits.
