- The campaign marks the successful commercial-scale PPQ completion of three 20,000-liter scale batches.
- Process innovation reduced cost by nearly 20% while boosting yield up to 80%.
- The site is the first and largest of its kind with four 20,000L stainless steel bioreactors in operation and an additional four projected to come online in 2027.
Altruist Biologics, an Innovent Biologics subsidiary and world-class contract development and manufacturing organization (CDMO), announced the successful completion of the first commercial project Process Performance Qualification (PPQ) campaign for its 20,000L stainless steel bioreactors at its Hangzhou site. The company completed three consecutive batches at large-scale mass production, demonstrating industry-leading capabilities in overcoming barriers to scale-up production.
Altruist’s integrated technologies were instrumental in maintaining process robustness and product quality consistency throughout, while maximizing manufacturing efficiency and productivity. In parallel with technical scale-up success, the company achieved substantial cost-of-good reduction with manufacturing costs reduced to below $50/g of monoclonal antibody drug substance. These improvements were enabled through economies of scale, implementation of advanced automation strategies, adoption of locally sourced raw materials, and continued process intensification and optimization.
Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, commented, “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. It underscores our commitment to providing clients with dependable, scalable manufacturing solutions as their programs advance from late-stage development to commercial supply. We will continue to strengthen our manufacturing capabilities through operational excellence and innovation to deliver long-term value for our partners worldwide.”
In 2024, the company commissioned four 20,000L stainless steel bioreactors, the first and largest of its kind in China at a single site, and the systems achieved successful commercial-scale engineering run in that same year. With four additional 20,000L stainless steel bioreactors and six 2,000L single-use bioreactors slated to come online in 2027, the site’s total capacity will increase from 80,000L to 172,000L upon completion.
Contact:
Mark Chen
mark.chen@altruistbio.com