WuXi Biologics has announced that three of its manufacturing facilities in Wuxi—Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and the Drug Product Packaging Centre (DPPC)—have received Good Manufacturing Practice (GMP) certification from South Korea’s Ministry of Food and Drug Safety.

The certification enables the company to offer fully integrated, end-to-end commercial manufacturing services covering both drug substance and drug product for a bispecific antibody therapy indicated for Biliary Tract Cancer.

The approval follows a five-day on-site inspection, during which all three facilities passed without any critical or major observations. The outcome reinforces WuXi Biologics’ strong quality systems and regulatory compliance, as well as its ability to handle large-scale manufacturing for complex biologics.

The certified facilities form part of the company’s global GMP manufacturing network, providing integrated capabilities that span drug substance production, fill-finish processes and customised packaging. This end-to-end infrastructure supports efficient commercial supply and scalability for advanced biologic therapies.

Company leadership noted that the certification underscores its commitment to global quality standards and enhances its ability to serve clients across South Korea and the broader Asia-Pacific region. The company continues to focus on strengthening its manufacturing ecosystem to accelerate the delivery of innovative therapies to patients worldwide.

WuXi Biologics has maintained a strong compliance track record, having passed numerous global regulatory inspections and client audits. Its expanding network of GMP-certified facilities supports a growing portfolio of biologics, including next-generation therapies such as bispecific antibodies.