Altruist Biologics, an Innovent Biologics subsidiary and contract development and manufacturing organization (CDMO), announced that its Hangzhou facility was granted the Drug Product Manufacturing License (C Certificate) from the Chinese National Medical Products Administration (NMPA). This is the first certificate awarded to a 20,000-liter scale biologics manufacturing facility in China, confirming that its quality systems, GMP facilities, and technologies meet the rigorous requirements of regulatory health authorities for drug production quality management.
Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, commented, "We're pleased that our Hangzhou facility successfully achieved the C Certificate for biologics commercial manufacturing. This represents another remarkable milestone in our efforts to establish premier-quality operations and fully integrated services to support our clients' commercialization goals. We look forward to supporting the development and manufacture of more life-saving treatments for our global clients to benefit patients worldwide."
The Hangzhou facility commenced partial operations in 2024 with the commissioning of four 20,000-liter stainless steel bioreactors, the first and largest of their kind in China. The site will hold a total capacity of 172,000 liters upon completion. It also offers a standalone ADC and AXC bioconjugation facility to support the manufacture of various bioconjugates, including high potency ADCs for clinical and commercial supply in both small- and large-scale production.