- Altruist Biologics has received a Drug Product Manufacturing License (C Certificate) from China’s NMPA for its Hangzhou facility.
- The site includes 20,000-liter bioreactors and supports large-scale biologics contract manufacturing and commercialization.
Altruist Biologics has received a Drug Product Manufacturing License (C Certificate) from China’s National Medical Products Administration (NMPA) for its Hangzhou facility, marking regulatory approval for commercial biologics manufacturing at the site.
The certification applies to the company’s 20,000-liter scale biologics manufacturing facility, confirming that its quality systems, GMP infrastructure, and production technologies meet regulatory requirements for drug product manufacturing. According to the company, this is the first certificate granted to a facility of this scale in China.
The Hangzhou site began partial operations in 2024 with four 20,000-liter stainless steel bioreactors and is expected to reach a total capacity of 172,000 liters upon completion. The facility also includes capabilities for antibody-drug conjugate (ADC) and AXC bioconjugation manufacturing, supporting both clinical and commercial production.
Altruist Biologics stated that the license strengthens its position as a CDMO supporting global pharmaceutical and biotech companies with contract manufacturing services. The company has supported the commercialization of eight products and has undergone 30 regulatory inspections, including those conducted by the FDA and EMA, as well as multiple GMP audits.
“We’re pleased that our Hangzhou facility successfully achieved the C Certificate for biologics commercial manufacturing.”
Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics
