WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the structural completion and key equipment arrival at its microbial commercial manufacturing site in Chengdu, marking an important milestone as the company advances toward GMP release for production by the end of 2026.

The microbial manufacturing site, broke ground last June in Wenjiang District of Chengdu, spans approximately 95,000 square meters and is designed for commercial drug substance (DS) and drug product (DP) manufacturing of microbial-derived biologics. A broad spectrum of next-generation therapies, including ADCs, cell therapies, bi-/multi-specific antibodies, and cancer vaccines, leverage recombinant proteins such as polypeptides, enzymes, antibody fragments, nanobodies, and cytokines. These recombinant proteins can be manufactured at scale through microbial fermentation, supported by compatible downstream purification and formulation processes. Microbial fermentation is gaining broad adoption across emerging biologic modalities, driven by its advantages in yield, development speed, scalability, process consistency, and cost efficiency.

Upon completion, the manufacturing site will be equipped with a 15,000 L fermenter, enabling up to 110 DS batches annually, with long-term expansion potential up to 60,000 L. It will also feature China's first dual-chamber lyophilization production line, jointly established with VISEN Pharmaceuticals, along with a vial-filling line that offers commercial DP manufacturing capacity of more than 10 million vials per year, further enhancing its commercial manufacturing capabilities for complex formulations.

In addition, the manufacturing site incorporates 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 also embedded into the site's design through green building practices such as sponge city design and the adoption of photovoltaic (PV) modules, enhancing overall resource and energy efficiency.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "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."

Powered by its proprietary E. coli expression system EffiX™, WuXi Biologics 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. Its microbial platform also features a multi‑tier capacity supporting production scale‑up from 15 L, 3000 L to 15,000 L, precisely aligned with preclinical, clinical, and commercial needs. By the end of 2025, WuXi Biologics' integrated microbial fermentation platform has successfully supported the development and manufacturing of 128 molecules.