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Altruist Biologics Wins First Commercial Manufacturing License for Hangzhou Facility

Altruist Biologics Wins First Commercial Manufacturing License for Hangzhou Facility

Altruist Biologics' Hangzhou facility has been 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, Good Manufacturing Practice (GMP) facilities, and technologies meet the rigorous requirements of regulatory health authorities for drug production quality management.

Speaking in this regard, Dr. Kaisong Zhou, Chairman and CEO, 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' commercialisation 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.

Building on its accumulated expertise and advanced technologies, the company will continuously strengthen its capabilities and quality systems to align with anticipated market needs, providing flexible, cost-effective services that help clients overcome manufacturing barriers and accelerate their life-saving therapies to patients.

More news about: manufacturing | Published by News Bureau | April - 09 - 2026

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