Altruist Biologics’ Hangzhou Facility Gets First Commercial-Scale Manufacturing License

An Altruist Biologics facility in Hangzhou, China received a Drug Product Manufacturing License from the Chinese National Medical Products Administration. The “C Certificate” is the first awarded to a 20,000-liter scale biologics manufacturing facility in China.

For Altruist, a CDMO subsidiary of Innovent Biologics, the certificate confirms the site meets requirements for drug production quality management. These rigorous standards encompass quality systems, good manufacturing practice (GMP) facilities, and certain other technologies.

More on Hangzhou Site

Four 20,000-liter stainless steel bioreactors were commissioned to allow the Hangzhou site to begin partial operations as of 2024. At that time, the bioreactors were not only the largest, but also the first of their kind in China. Eventually, the completed facility will accommodate a capacity of 172,000 total liters.

Additionally, the Hangzhou site boasts a standalone bioconjugation facility that supports the manufacture of, among others, high-potency antibody-drug conjugates. These can be manufactured for either clinical or commercial supply, in both small- and large-scale production.

Altruist History of Commercialization

Capabilities such as these have allowed Altruist to successfully commercialize eight products to date. Several of these have garnered regulatory submissions in China, the United States, and across Europe.

Altruist Biologics Chairman and CEO Kaisong Zhou, PhD, reacted to news of the certification.

“We’re pleased that our Hangzhou facility successfully achieved the C Certificate for biologics commercial manufacturing,” Zhou said. “[It’s a] 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.”

Altruist Biologics has passed 30 regulatory inspections, as well as 13 GMP quality audits by global clients.