Altruist Biologics receives EMA GMP certification for Suzhou facility

Altruist Biologics has announced that its commercial manufacturing facility in Suzhou, China, has passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with no critical findings. This certification allows the contract development and manufacturing organization (CDMO) to begin manufacturing a biological product for an existing client.

The Suzhou facility features a dedicated antibody drug conjugate (ADC) manufacturing line and 60,000 liters of antibody manufacturing capacity. The company is also expanding its footprint through a larger site in Hangzhou, which currently holds 172,000 liters of capacity. A new 2,000-liter antibody production line is under construction in Hangzhou and is expected to be operational by mid-2027. Once all planned expansions are complete, Altruist Biologics aims to have a total capacity of 232,000 liters.

Both the Suzhou and Hangzhou sites are designed to comply with requirements from major global regulatory bodies, including the EMA, the US Food and Drug Administration (FDA), and China’s National Medical Products Administration (NMPA).