WuXi Biologics completes first GMP run at MFG17, its 25th drug‑substance facility
- MFG17 completed its first GMP production campaign with zero deviations and stable critical process parameters.
- The facility uses single‑use bioreactors with a total manufacturing capacity of 9,000 litres and targets 80–100 batches annually.
- MFG17 supports fed‑batch, N‑1 perfusion, perfusion, intensified perfusion and fully automated continuous manufacturing.
- MFG17 is WuXi Biologics' 25th drug substance facility and will integrate with the Fengxian site for end‑to‑end discovery‑to‑commercial operations.
First GMP campaign
MFG17 at the Shanghai Fengxian site has successfully completed its first GMP production campaign with zero deviations; critical process parameters remained stable and yields met expected levels, indicating robust process execution.
Capacity and process flexibility
The single‑use facility has a total manufacturing capacity of 9,000 litres and is configured to run 80–100 batches annually. It is designed to support a range of process modes across clinical and commercial stages, including fed‑batch, N‑1 perfusion, perfusion, intensified perfusion and fully automated continuous manufacturing.
Digitalization and site integration
MFG17 implements automation, digital technologies and advanced infrastructure intended to convert data and predictive modelling into smarter operational management and higher production efficiency. The facility will work in close synergy with other operations at the Fengxian site to accelerate end‑to‑end integration from discovery to development and from drug substance to drug product.
Network scale and quality record
As the 25th drug substance manufacturing facility in WuXi Biologics’ global network, MFG17 complements the company’s dual‑sourcing strategy for technology transfer, scale‑up and multi‑regional registration. The company reports that as of 2025 it has delivered over 2,350 drug substance batches and over 2,260 drug product batches, passed 46 regulatory inspections worldwide (including 22 by EMA and FDA) with a reported 100% success rate and no critical findings, and completed more than 1,800 GMP client audits.
Source: WuXi
