WuXi Biologics said its MFG17 drug substance facility at the Shanghai Fengxian site has successfully completed its first GMP production campaign, with manufacturing executed without any deviations. Critical process parameters remained stable and yields met expected levels during the initial run, which the company said demonstrates robust process performance and execution capabilities. MFG17 is the 25th drug substance manufacturing facility in WuXi Biologics’ global network and is designed to provide scalable services for a wide range of biologics at both clinical and commercial stages.
To support projects at different points in development, MFG17 is equipped with multiple single‑use bioreactors, providing a total manufacturing capacity of 9,000 liters and enabling 80 to 100 batches per year. The facility is configured to meet global regulatory requirements while offering flexibility across process modes, including fed‑batch, N‑1 perfusion, perfusion, intensified perfusion and fully automated continuous manufacturing. WuXi Biologics said these options are intended to improve operational efficiency and process productivity and to support robust scale‑up and reliable supply for complex biologic products.
The company is also advancing a digitalization strategy at MFG17, implementing automation, digital technologies and upgraded infrastructure across the manufacturing value chain. By integrating data, computational tools and predictive modeling into plant operations, the facility aims to improve operational management and production efficiency and to offer more cost‑competitive manufacturing solutions.
MFG17 will operate in close coordination with other units at the Fengxian site, with the goal of strengthening end‑to‑end integration from discovery and development through clinical and commercial manufacturing and from drug substance to drug product. WuXi Biologics said this integrated model is intended to enable faster and more efficient project delivery for clients seeking outsourced research, development and manufacturing support for biologics.