Chinese contract development and manufacturing organization Altruist Biologics announced that its commercial manufacturing facility in Suzhou, China has passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with zero critical findings, enabling the manufacture of a product for an undisclosed biopharma customer.

It marks the first time the Suzhou facility, which has a dedicated antibody-drug conjugate (ADC) manufacturing line and 60,000 liters of antibody production capacity, has successfully received EMA GMP certification.

The site, which provides end-to-end services for antibodies, fusion proteins, and ADCs, has also successfully completed remote interactive evaluation by the U.S. FDA and has passed inspections by the NMPA and the Federal Committee for Protection from Sanitary Risks (COFEPRIS) of Mexico, as well as more than 40 quality audits conducted by global customers.

“The recent EMA GMP certification exemplifies that our robust manufacturing processes, quality systems, talent and world-class facility meet regulatory requirements, and we have the agency’s trust to manufacture and deliver products on behalf of our global partners and the patients they serve,” Kaisong Zhou, chairman and CEO of Altruist Biologics, said in a statement.

The latest milestone builds on recent regulatory progress at Altruist Biologics’ Hangzhou, China site. In July, Altruist received regulatory approval for segmented production of antibody-drug conjugates (ADCs), allowing clinical and commercial manufacturing at the facility. The approval followed another milestone earlier this year when the CDMO received China’s first GMP manufacturing license for a biologics facility operating at the 20,000-liter scale.

Last month, Altruist also announced the completion of its first commercial process performance qualification (PPQ) campaign using 20,000-liter stainless steel bioreactors at its Hangzhou site. A 2,000-liter antibody production line is currently under construction at the site and is slated to be operational by mid-2027.

Combined, Altruist says it has 140,000 liters of operational CDMO manufacturing capacity, representing approximately 20% of China’s total capacity. Altruist’s total manufacturing capacity is expected to reach 232,000 liters. When it comes online, Altruist claims it will position the company among the top 10 biologics CDMOs globally by manufacturing capacity.