- WuXi Biologics has received GMP certification from South Korea’s MFDS for three manufacturing facilities in Wuxi.
- The certification enables end-to-end commercial manufacturing for a bispecific antibody targeting biliary tract cancer.
WuXi Biologics has obtained GMP certification from South Korea’s Ministry of Food and Drug Safety (MFDS) for three of its manufacturing facilities in Wuxi, China. The certified sites include Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and the Drug Product Packaging Center (DPPC).
The certification follows a five-day on-site inspection, during which all three facilities passed without any critical or major findings. The approval allows the company to provide end-to-end commercial manufacturing services for a bispecific antibody indicated for the treatment of biliary tract cancer, covering both drug substance and drug product.
The three facilities are part of WuXi Biologics’ global GMP manufacturing network and offer integrated capabilities across drug substance production, drug product fill-finish, and packaging. These capabilities support commercial supply requirements for biologic therapies and align with the company’s contract manufacturing and CDMO services.
The announcement also reflects WuXi Biologics’ broader regulatory track record. As of the end of 2025, the company reported passing 46 regulatory inspections, including 22 by the FDA and EMA, and securing 136 facility license approvals. It also reported a 100% pass rate for FDA Pre-License Inspections and more than 1,800 GMP quality audits conducted by global clients.
“Receiving GMP certification from the MFDS demonstrates our continued commitment to the global standards of quality and regulatory compliance.”
Dr. Chris Chen, Chief Executive Officer of WuXi Biologics
