Altruist Biologics has completed the first commercial process performance qualification campaign for its 20,000L stainless steel bioreactors at its Hangzhou site, marking successful commercial-scale completion of three consecutive batches. The company said the milestone shows it can move large-scale manufacturing from late-stage preparation into commercial supply.
The campaign at the Innovent Biologics subsidiary’s Hangzhou facility was presented as a proof point for its commercial manufacturing capabilities, with integrated technologies helping maintain process robustness and product quality consistency throughout the run. Altruist said the effort also delivered a substantial manufacturing gain, reducing costs by nearly 20% while boosting yield up to 80%.
The company said manufacturing costs fell to below $50 per gram of monoclonal antibody drug substance through economies of scale, advanced automation, locally sourced raw materials and continued process intensification and optimization. Chairman and CEO Dr. Kaisong Zhou said the successful PPQ campaign marks an important step in Altruist Biologics’ evolution as a global commercial manufacturing partner and reflects the maturity of its manufacturing operations, quality systems and team.
Altruist said its Hangzhou site was the first and largest of its kind in China when four 20,000L stainless steel bioreactors were commissioned in 2024, and the system completed a commercial-scale engineering run that same year. The site currently has four 20,000L stainless steel bioreactors in operation, with four more expected online in 2027, along with six 2,000L single-use bioreactors.
When the expansion is complete, the site’s total capacity is expected to rise from 80,000L to 172,000L. Altruist said the additional capacity will help support dependable, scalable manufacturing for clients as their programs move from late-stage development to commercial supply.