WuXi Biologics on track for 2026 GMP release at microbial manufacturing site in China

Targeting the growing market for recombinant proteins, WuXi Biologics announced structural completion and key equipment arrival at its microbial commercial manufacturing site in Chengdu, China, which is designed for commercial drug substance and drug product production. 

Last year, the Chinese contract research, development and manufacturing organization (CRDMO) started construction on the 95,000-square-meter microbial manufacturing facility. Once completed, the site will be equipped with a 15,000L fermenter — with future expansion potential to 60,000L — and what the company claims will be China’s first dual-chamber lyophilization production line, jointly established with VISEN Pharmaceuticals.

The site, located in the Wenjiang district of Chengdu, is expected to produce up to 110 drug substance batches per year and a vial filling line providing a total drug product output capacity of more than 10 million vials annually. Commercial production at the site will include lonapegsomatropin, VISEN Pharmaceuticals’ long-acting growth hormone for pediatric growth hormone deficiency.

“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,” WuXi Biologics CEO Chris Chen said in a statement. “Combined with our research, development and clinical manufacturing capabilities in Shanghai and Hangzhou, we can provide end‑to‑end CRDMO service from strain development through commercial manufacturing for global pharmaceutical innovators.”

The Chengdu facility is slated for current Good Manufacturing Practice (GMP) release for production by the end of 2026. WuXi Biologics is looking to capitalize on the microbial CRDMO services market, which is poised for significant expansion due to growing demand for recombinant proteins — such as antibody fragments, cytokines, enzymes, nanobodies, plasmid DNA, and polypeptides — manufactured at scale through fermentation.

“A broad spectrum of next-generation therapies, including ADCs, cell therapies, bi-/multi-specific antibodies, and cancer vaccines, leverage recombinant proteins,” according to WuXi Biologics. “Microbial fermentation is gaining broad adoption across emerging biologic modalities, driven by its advantages in yield, development speed, scalability, process consistency, and cost efficiency.”

Technological advancements

At the Chengdu site, WuXi Biologics will deploy its EffiX microbial expression platform, which supports high-yield, scalable production of non-monoclonal antibody (non-mAb) recombinant proteins.

The company contends that its proprietary EffiX E. coli expression system results in titers of up to 15 g/L for non-mAb recombinant proteins and more than 1 g/L for plasmid DNA, providing a complete Chemistry, Manufacturing, and Controls (CMC) package “from plasmid DNA to IND filing within six months.” EffiX also has multi‑tier capacity supporting production scale‑up from 15L, 3000L to 15,000L, “precisely aligned with preclinical, clinical, and commercial needs,” according to WuXi Biologics.

The Chengdu facility is designed to integrate automation and digital systems across its upstream and downstream operations to support GMP manufacturing, regulatory compliance, operational efficiency, and data integrity, the company said. The site’s design also has energy efficiency and environmental sustainability features, including green building practices such as sponge city design and the use of photovoltaic modules.

As advancements in microbial fermentation and downstream processing are driving more efficient, large-scale production of complex biologics, WuXi’s competitors in the CRDMO market such as Fujifilm Biotechnologies, Lonza, Samsung Biologics, and Thermo Fisher Scientific are also investing in capacity and technology enhancements to meet the growing demand for the development and manufacturing of microbial-derived biologics.

Last month, Fujifilm Biotechnologies launched a precision purification technology called ShunzymeX, designed to streamline downstream processing for complex microbial-expressed biologics. ShunzymeX uses a proprietary protease to enable affinity tag-based purification with off-the-shelf affinity resins. According to Fujifilm, the platform addresses limitations in traditional microbial downstream purification, where variability in protein size and sequence can complicate resin selection and chromatography development.