WuXi Biologics gets South Korean GMP certification for bispecific antibody manufacturing

WuXi Biologics, a global contract research, development, and manufacturing organization (CRDMO), announced that three manufacturing facilities in Wuxi, China, have received Good Manufacturing Practice (GMP) certification from South Korea’s Ministry of Food and Drug Safety, enabling commercial manufacturing of a bispecific antibody for biliary tract cancer.

The certification covers the company’s Drug Substance Facility 5, Drug Product Facility 2, and Drug Product Packaging Center, supporting integrated capabilities from drug substance manufacturing through fill-finish and packaging. The approval follows a five-day inspection with no critical or major findings.

According to the company, the certified facilities are part of its global GMP network and provide end-to-end manufacturing services designed to support commercial-scale production of complex biologics. The integrated setup is intended to streamline supply and improve operational efficiency for biologics programs targeting global markets.

WuXi Biologics said the certification strengthens its ability to support customers in South Korea and the broader Asia-Pacific region, particularly for advanced modalities such as bispecific antibodies.

The development aligns with the company’s broader strategy to expand its integrated CRDMO model, which combines research, development and manufacturing capabilities to improve speed, flexibility and consistency across biologics programs. The company has reported growing demand for complex modalities, including bispecific and multispecific antibodies, within its pipeline.