信达生物旗下Altruist完成杭州20,000L产线首个商业PPQ项目

Altruist Biologics Completes First Commercial PPQ Campaign of its 20,000L Production Line at the Hangzhou Site
- 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.
HANGZHOU, China, Aug. 5, 2026 /PRNewswire/ -- 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.
For more information about Altruist Biologics' end-to-end service capabilities, please visit: www.altruistbio.com.
About Altruist Biologics
Altruist Biologics is a reliable CDMO service provider and wholly owned subsidiary of Innovent Biologics, focusing on the development, clinical, and commercial manufacturing of antibodies, fusion proteins, recombinant proteins, antibody drug conjugates, and other drugs. The company operates advanced cGMP facilities in Suzhou and Hangzhou, China, with a total production capacity of 232,000 liters, and continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility, safety, and agility for clients. With over a decade of bioprocessing expertise, the company has supported the commercialization of 18 drugs and completed more than 2,000 commercial batches with a >99.8% success rate. Its track record includes 100 global regulatory filings with the FDA, EMA, NMPA, PMDA, TGA, and BPOM as well as over 80 successful authority audits. With over 1,000 employees, including leading experts and scientists spanning all areas of biologics production and innovation, Altruist is committed to supporting clients in developing affordable and high-quality biopharmaceuticals for the benefit of patients worldwide.
SOURCE Altruist Biologics