- DP15 at Fengxian (Shanghai) achieved GMP release in April and completed engineering and GMP batches to deliver clinical supplies for regulatory filings.
- DP15 uses isolator-based aseptic filling for liquid and lyophilized products, with 100% fill-weight check, nitrogen overlay, low-temperature lyophilization loading, and vial sizes 2R-20R.
- It is WuXi Biologics' 18th operational drug product facility, integrated with surrounding site operations to accelerate tech transfer from development to GMP.
- By end-2025 WuXi reported >2,350 drug substance batches, >2,260 drug product batches, 46 regulatory inspections (22 EMA/FDA) with no critical findings, and >1,800 GMP client audits.
GMP release and operations
WuXi Biologics' DP15 at Fengxian achieved GMP release in April and has completed engineering and GMP batches, delivering clinical supplies to support regulatory filings and development programs.
Facility capabilities
DP15 is equipped with isolator-based aseptic filling for both liquid and lyophilized products, 100% fill-weight checks, nitrogen overlay, low-temperature lyophilization loading, and can fill vials from 2R to 20R.
Network integration and role
As the company's 18th operational drug product facility, DP15 is integrated with surrounding site operations to accelerate technology transfer and the transition from development to GMP manufacturing.
Production and compliance record
By end-2025 the company reported over 2,350 drug substance batches and over 2,260 drug product batches produced, 46 regulatory inspections (including 22 EMA/FDA) without critical findings, and more than 1,800 GMP client audits.
Delivery formats
Across its network the company supports liquid and lyophilized vials, pre-filled syringes, dual‑chamber cartridges and a range of safety and automated combination products.
