WuXi Biologics (HK:2269), a China-based, global Contract Research, Development and Manufacturing Organisation (CRDMO), announced on Friday the structural completion and key equipment arrival at its microbial commercial manufacturing site in Chengdu, as the company advances toward GMP release for production by the end of 2026.

The microbial manufacturing site, which broke ground last June in Wenjiang District of Chengdu, spans approximately 95,000 square metres 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, WuXi Biologics said.

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 lyophilisation 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.