WuXi Biologics’ Suzhou biosafety testing center gets fourth EMA GMP certification

WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO) headquartered in Shanghai, China, announced that its Biosafety Testing Center in Suzhou has received its fourth European Medicines Agency (EMA) Good Manufacturing Practices (GMP) certification following an inspection that resulted in zero critical findings.

According to the announcement, the inspection supported European Union marketing authorization applications for 19 biologics from 13 clients, with the majority developed and manufactured using WuXi Biologics’ integrated platform. The products include antibodies, enzymes, and fusion proteins.

The EMA inspection focused on GMP-compliant biosafety quality control testing for cell banks and commercial unprocessed bulk associated with the biologics seeking EU approval. During the four-day review, inspectors reportedly evaluated quality management systems, facilities and equipment, testing methods, standard operating procedures, computerized systems, personnel qualifications and data integrity controls.

WuXi Biologics said its Biosafety Testing Center operates facilities in Suzhou and Shanghai that provide cell bank characterization for Chinese hamster ovary (CHO), HEK293 and E. coli expression systems, as well as biosafety testing services, GMP release testing for commercial products, and GLP-compliant viral clearance studies. As of December 2025, the company said the center had supported more than 1,700 investigational new drug and biologics license applications.

The company added that the center has completed a remote interactive evaluation by the U.S. Food and Drug Administration and passed inspections by multiple regulatory agencies, including China’s National Medical Products Administration, Health Canada, Australia’s Therapeutic Goods Administration and Japan’s Pharmaceuticals and Medical Devices Agency. The facilities have also undergone more than 510 quality audits by global clients.

The certification follows continued expansion of WuXi Biologics’ global manufacturing network. Earlier this month, the company completed the structural topping-out of a 30,000-square-meter drug product facility at its Singapore hub in Tuas Biomedical Park.

The facility is expected to begin operations in 2027 and will be capable of producing approximately 100 million units of pre-filled syringes and vials annually. The Singapore campus is also planned to add 120,000 liters of drug substance manufacturing capacity to the company’s global network.