Contract development and manufacturing organisation (CDMO) Altruist Biologics, a subsidiary of Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801), announced on Wednesday that its application for segmented production of antibody-drug conjugates (ADCs) at its Hangzhou site successfully passed a comprehensive inspection from three provincial regulatory bodies in China.

According to Altruist, this is the first case to receive a trilateral approval and marks a further upgrade of the company's ADC manufacturing expertise and integrated capabilities.

Altruist Biologics' Hangzhou site provides a standalone ADC & AXC bioconjugation facility supporting the manufacture of various bioconjugates, including high potency ADCs for clinical and commercial supply in both small- and large-scale production. It includes fully integrated laboratories dedicated to ADC process development, quality control, and MSAT to support seamless progression from development to manufacturing.

The facility features single-use reactor systems supporting conjugation scales of up to 500 L with 1,000 L-5,000 L under construction, ultimately providing the flexibility and capacity required for scalable ADC drug substance manufacturing. It also has fully automated, isolator-based aseptic filling system with two 7.5m2 and three 35m2 lyophilisers.

It is designed for the safe handling of high-potency APIs (HPAPIs), and incorporates stringent high-containment systems, ensuring the highest standards of safety, regulatory compliance, and operational control.

The company has successfully managed over 40 ADC and AXC projects, and has developed ADC molecules spanning from pre-IND to phase 3 and PPQ.