- WuXi Biologics has received ANVISA GMP certification for two manufacturing facilities and its drug product packaging center in Wuxi, China, enabling end-to-end commercial manufacturing for an anti-PD-L1 monoclonal antibody.
- The facilities passed a five-day inspection with zero findings, supporting commercial manufacturing and supply for the Brazilian market.
WuXi Biologics has received GMP certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for its Drug Substance Facility 2 (MFG2), Drug Product Facility 1 (DP1), and Drug Product Packaging Center (DPPC) in Wuxi, China. The certification enables the company to provide end-to-end CDMO and contract manufacturing services, covering both drug substance and drug product, for an anti-PD-L1 monoclonal antibody used in cancer immunotherapy.
The certification followed a five-day ANVISA inspection, during which the three facilities passed with zero findings. According to the company, the outcome validates its quality management systems, GMP execution, and cross-functional collaboration while supporting commercial manufacturing and supply for global customers, including entry into the Latin American market.
WuXi Biologics said the certified facilities provide integrated capabilities spanning large-scale biologics drug substance manufacturing, clinical and commercial drug product fill-finish, and customized packaging. Together, these operations are designed to support seamless manufacturing and commercial supply for biologic therapies while meeting regulatory requirements across major global markets.
“Receiving ANVISA GMP certification reflects WuXi Biologics’ continued commitment to global quality and compliance standards, and further validates our international standards across facilities, quality systems, and GMP execution.”
Dr. Chris Chen, CEO of WuXi Biologics
As of the end of 2025, the company said it had completed 46 regulatory inspections, including 22 by the FDA and EMA, secured 136 facility license approvals, and maintained a 100% pass rate for FDA Pre-License Inspections. WuXi Biologics also said it currently operates 15 GMP-certified drug substance and drug product facilities across its global manufacturing network.
