- WuXi Biologics has completed the first GMP production campaign at its MFG17 drug substance facility in Shanghai, with zero deviations and expected process yields.
- The 9,000-liter facility expands the company’s global manufacturing network and is designed to support clinical and commercial biologics production.
WuXi Biologics has completed the first GMP production campaign at its MFG17 drug substance manufacturing facility in Shanghai’s Fengxian site. The company said the campaign was completed with zero deviations, while critical process parameters remained stable and production yields met expected levels. MFG17 is the 25th drug substance manufacturing facility within the company’s global network and is designed to support biologics programs from clinical development through commercial manufacturing.
The facility has a total manufacturing capacity of 9,000 liters using multiple single-use bioreactors and is designed to produce 80 to 100 batches annually. According to the company, MFG17 supports multiple manufacturing approaches, including fed-batch, N-1 perfusion, perfusion, intensified perfusion, and fully automated continuous manufacturing, providing flexibility for a range of biologics and development stages.
WuXi Biologics said MFG17 incorporates automation, digital technologies, and advanced infrastructure throughout its manufacturing operations to improve operational management and production efficiency. The facility will also operate alongside other manufacturing operations at the Fengxian site to support integrated services spanning discovery, development, drug substance, drug product, and commercial manufacturing.
“The successful completion of the first GMP production at MFG17 further strengthens our manufacturing capabilities. Leveraging highly flexible single-use technologies and continuously advancing digital capabilities, we not only provide high-quality manufacturing support for our customers, but also serve as an extension of their capabilities, empowering global partners to accelerate the delivery of innovative biologics to patients worldwide.”
Dr. Chris Chen, CEO of WuXi Biologics
The company said the new facility supports its global dual-sourcing strategy for technology transfer, scale-up, and multi-regional registration. WuXi Biologics currently operates five research centers, 10 development centers, and 18 manufacturing sites across China, the United States, Ireland, Germany, and Singapore, including 25 drug substance facilities and 18 drug product facilities.
