WuXi Biologics Completes Structure of Chengdu Microbial Manufacturing Site

WuXi Biologics has completed the structure of a new microbial commercial manufacturing site in Chengdu and received key equipment shipments, as the contract development and manufacturing company works toward a good-manufacturing-practice, or GMP, release for production by the end of 2026.

The site, in Chengdu’s Wenjiang District, broke ground in June 2025 and covers about 95,000 square meters. It is designed to make both drug substance and drug product for biologics derived from microbial fermentation, including recombinant proteins used in therapies such as antibody-drug conjugates, cell therapies, multispecific antibodies and cancer vaccines.

WuXi said the facility will include a 15,000-liter fermenter with capacity for as many as 110 drug-substance batches a year, with an expansion path to 60,000 liters. The site is also slated to include what the company described as China’s first dual-chamber lyophilization production line, developed with VISEN Pharmaceuticals, and a vial-filling line with capacity of more than 10 million vials annually.

The plant is being built with integrated automation and digital systems across upstream and downstream operations, and its design includes green-building features such as sponge-city water management and photovoltaic modules.

WuXi said its microbial platform is based on an E. coli expression system it calls EffiX, with reported recombinant protein titers of up to 15 grams per liter. The company can deliver a chemistry, manufacturing and controls package from plasmid DNA to an investigational-new-drug filing within six months, and its fermentation capacity supports scale-up from 15 liters to 3,000 liters and 15,000 liters.

Dr. Chris Chen, CEO of WuXi Biologics, said, “The structural completion of our Chengdu microbial manufacturing site represents an important step forward in strengthening our commercial-scale microbial capabilities. 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. 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.”

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In April, WuXi Biologics achieved ISO 13485:2016 Medical Device Quality Management System certification with zero non-conformities.