Chinese CDMO Facilities Achieve Major Manufacturing Milestones as Biologics Production Capacity Expands
核心洞察
Altruist Biologics (搜索)' Hangzhou facility received China's first commercial manufacturing license for a 20,000-liter scale biologics facility, demonstrating rapid regulatory approval within two months of qualification.
WuXi Biologics completed structural construction of its Chengdu microbial manufacturing site, featuring a 15,000L fermenter with capacity for 110 drug substance batches annually and China's first dual-chamber lyophilization production line.
Both facilities represent significant expansions in China's contract manufacturing capabilities, with Altruist supporting eight commercialized products and WuXi Biologics managing 945 integrated client projects including 25 in commercial manufacturing.
Two major Chinese contract development and manufacturing organizations (CDMOs) have achieved significant manufacturing milestones that underscore the rapid expansion of biologics production capacity in China. Altruist Biologics (搜索) secured the first commercial manufacturing license for a 20,000-liter scale facility, while WuXi Biologics completed structural construction of its advanced microbial manufacturing site in Chengdu.
Altruist Biologics Achieves Regulatory Milestone
Altruist Biologics (搜索), an Innovent Biologics (搜索) subsidiary, announced that its Hangzhou facility received the Drug Product Manufacturing License (C Certificate) from the Chinese National Medical Products Administration (搜索) (NMPA). The facility represents the first certificate awarded to a 20,000-liter scale biologics manufacturing facility in China, confirming that its quality systems, GMP facilities, and technologies meet rigorous regulatory requirements for drug production quality management.
The achievement is particularly notable for its rapid timeline, with only two months elapsed from facility qualification to licensure. This demonstrates the company's commitment to outstanding technical capabilities and a rigorous quality management system that upholds international standards.
"We're pleased that our Hangzhou facility successfully achieved the C Certificate for biologics commercial manufacturing," said Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics (搜索). "This represents another remarkable milestone in our efforts to establish premier-quality operations and fully integrated services to support our clients' commercialization goals."
The Hangzhou facility commenced partial operations in 2024 with the commissioning of four 20,000-liter stainless steel bioreactors, the first and largest of their kind in China. The site will hold a total capacity of 172,000 liters upon completion and offers a standalone ADC and AXC (搜索) bioconjugation facility to support the manufacture of various bioconjugates, including high potency ADCs for clinical and commercial supply.
WuXi Biologics Advances Microbial Manufacturing Capabilities
WuXi Biologics announced the structural completion and key equipment arrival at its microbial commercial manufacturing site in Chengdu, marking progress toward GMP release for production by the end of 2026. The facility, which broke ground last June in Wenjiang District of Chengdu, spans approximately 95,000 square meters and is designed for commercial drug substance and drug product manufacturing of microbial-derived biologics.
Upon completion, the manufacturing site will be equipped with a 15,000L fermenter, enabling up to 110 drug substance batches annually, with long-term expansion potential up to 60,000L. The facility will feature China's first dual-chamber lyophilization production line, jointly established with VISEN Pharmaceuticals (搜索), along with a vial-filling line offering commercial drug product manufacturing capacity of more than 10 million vials per year.
"The structural completion of our Chengdu microbial manufacturing site represents an important step forward in strengthening our commercial-scale microbial capabilities," commented Dr. Chris Chen, CEO of WuXi Biologics. "Designed to facilitate efficient technology transfer and reliable commercial supply, the site reflects the growing adoption of microbial technologies across emerging modalities and advanced therapies."
Technology Platform Advantages Drive Adoption
Microbial fermentation is gaining broad adoption across emerging biologic modalities, driven by advantages in yield, development speed, scalability, process consistency, and cost efficiency. A broad spectrum of next-generation therapies, including ADCs, cell therapies, bi-/multi-specific antibodies, and cancer (搜索) vaccines, leverage recombinant proteins such as polypeptides, enzymes, antibody fragments, nanobodies, and cytokines that can be manufactured at scale through microbial fermentation.
WuXi Biologics' proprietary E. coli (搜索) expression system EffiX™ achieves recombinant protein titers of up to 15 g/L and delivers a complete CMC package from plasmid DNA to IND filing within six months. The company's microbial platform features multi-tier capacity supporting production scale-up from 15L, 3000L to 15,000L, precisely aligned with preclinical, clinical, and commercial needs.
Established Track Records in Commercial Manufacturing
Both companies demonstrate proven capabilities in supporting commercial biologics manufacturing. Altruist has supported the successful commercialization of eight products, with several achieving regulatory submissions across the United States, Europe, and China. The company has successfully passed 30 regulatory inspections, including one conducted by the FDA and EMA, as well as more than 13 GMP quality audits conducted by global clients.
WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio. By the end of 2025, the company's integrated microbial fermentation platform has successfully supported the development and manufacturing of 128 molecules.
The manufacturing sites incorporate integrated automation and digital systems across upstream and downstream operations to support reliable GMP manufacturing, strengthening compliance, operational efficiency, and data integrity. ESG concepts are embedded into site designs through green building practices such as sponge city design and adoption of photovoltaic modules, enhancing overall resource and energy efficiency.