WuXi Biologics (Cayman) Inc. announced that three of its manufacturing facilities in Wuxi ? Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and Drug Product Packaging Center (DPPC) ? have received GMP certification from South Korea Ministry of Food and Drug Safety (MFDS).
The certification positions WuXi Biologics to provide end-to-end commercial manufacturing services, covering both drug substance and drug product, for a bispecific antibody indicated for the treatment of biliary tract cancer. During the five-day on-site inspection, all three facilities successfully passed the MFDS assessment with no critical or major findings, reaffirming WuXi Biologics' robust quality and compliance systems, as well as its proven capability to execute GMP-compliant large-scale manufacturing for complex biologic programs. Within WuXi Biologics' global GMP manufacturing network, MFG5, DP2 and DPPC collectively provide integrated, end-to-end capabilities spanning drug substance manufacturing, drug product fill-finish, and customized packaging, enabling efficient commercial supply of innovative biologic therapies.
