Altruist Biologics, a China-based contract development and manufacturing organization (CDMO) and subsidiary of Innovent Biologics, has completed its first commercial process performance qualification (PPQ) campaign using 20,000-liter stainless steel bioreactors at its Hangzhou manufacturing site.

The campaign included three consecutive commercial-scale PPQ batches for a monoclonal antibody drug substance, validating manufacturing performance and process consistency at the 20,000-liter scale. According to the company, the campaign also demonstrated the site’s ability to support commercial biologics production while maintaining product quality and manufacturing efficiency.

Altruist said manufacturing costs for monoclonal antibody drug substance were reduced to below $50 per gram through economies of scale, increased automation, locally sourced raw materials, and continued process optimization.

The Hangzhou facility currently operates four 20,000-liter stainless steel bioreactors, which entered service in 2024 following successful engineering runs. The company plans to add four additional 20,000-liter stainless steel bioreactors and six 2,000-liter single-use bioreactors in 2027, increasing total manufacturing capacity from 80,000 liters to 172,000 liters.

The latest milestone builds on recent regulatory progress at the Hangzhou site. In July, Altruist received regulatory approval for segmented production of antibody-drug conjugates (ADCs), allowing clinical and commercial manufacturing of ADCs at the facility. The approval followed another milestone earlier this year when the company received China’s first GMP manufacturing license for a biologics facility operating at the 20,000-liter scale.