WuXi Biologics secures ANVISA GMP for MFG2, DP1 and DPPC to enable commercial anti‑PD‑L1 manufacturing
- ANVISA granted GMP certification to MFG2, DP1 and DPPC in Wuxi for commercial manufacture of an anti‑PD‑L1 monoclonal antibody.
- The three facilities passed ANVISA’s five‑day inspection with zero findings.
- WuXi reports 46 regulatory inspections passed by end‑2025, including 22 by FDA and EMA, and 136 facility license approvals.
- The company operates 15 GMP‑certified drug substance and drug product facilities and says the certified sites provide integrated large‑scale drug substance, fill‑finish and customized packaging capabilities.
Certification and scope
Two drug substance/product facilities (MFG2, DP1) and the Drug Product Packaging Center (DPPC) in Wuxi received ANVISA GMP certification to provide end‑to‑end commercial manufacturing for an anti‑PD‑L1 monoclonal antibody used in cancer immunotherapy.
Inspection results and quality
The three sites passed ANVISA’s five‑day inspection with zero findings, which the company cites as evidence of a robust quality management system, mature GMP execution and effective cross‑functional collaboration.
Network capabilities
MFG2, DP1 and DPPC together cover large‑scale biologics drug substance manufacturing, clinical and commercial drug product fill‑finish, and customized packaging, designed to meet regulatory requirements across major markets and enable seamless commercial supply.
Regulatory track record and leadership comment
WuXi Biologics reported 46 regulatory inspections passed as of end‑2025 — including 22 by FDA and EMA — 136 facility license approvals, a 100% FDA Pre‑License Inspection pass rate, and more than 1,800 GMP client audits; the company currently operates 15 GMP‑certified drug substance and drug product facilities. CEO Dr. Chris Chen said the ANVISA certification validates the company’s global quality standards and will help clients’ commercialization strategies, including entry into Latin America.
Source: WuXi
