- Altruist Biologics has completed its first commercial Process Performance Qualification (PPQ) campaign using 20,000L stainless steel bioreactors at its Hangzhou manufacturing site.
- The campaign included three consecutive commercial-scale batches and reduced monoclonal antibody drug substance manufacturing costs to below $50 per gram.
Altruist Biologics, a subsidiary of Innovent Biologics and a contract development and manufacturing organization (CDMO), has completed its first commercial Process Performance Qualification (PPQ) campaign using 20,000-liter stainless steel bioreactors at its manufacturing site in Hangzhou, China. The company successfully produced three consecutive commercial-scale batches, demonstrating its capability to support large-scale biologics manufacturing.
According to the company, the PPQ campaign maintained process robustness and product quality consistency while improving manufacturing efficiency. Altruist Biologics said manufacturing costs for monoclonal antibody drug substance were reduced to below $50 per gram, attributing the reduction to economies of scale, advanced automation, locally sourced raw materials, and continued process intensification and optimization.
“The successful completion of our first commercial PPQ campaign on the 20,000-liter production line at our Hangzhou manufacturing site marks an important milestone in Altruist Biologics’ evolution as a global commercial manufacturing partner. Executing three consecutive PPQ batches at this scale reflects the maturity of our manufacturing operations, the strength of our quality systems, and the dedication of our team to operational excellence.”
Dr. Kaisong Zhou, Chairman and Chief Executive Officer of Altruist Biologics
The company commissioned four 20,000L stainless steel bioreactors in 2024, which it describes as the first and largest installation of its kind at a single site in China. Altruist Biologics plans to bring four additional 20,000L stainless steel bioreactors and six 2,000L single-use bioreactors online in 2027, increasing the site’s total manufacturing capacity from 80,000L to 172,000L.
