- WuXi Biologics announced that its Drug Product Facility 15 (DP15) in Shanghai achieved GMP release in April and has entered operational use for clinical supply manufacturing.
- The facility supports liquid and lyophilized drug product manufacturing and expands the company’s global biologics manufacturing network to 18 operational drug product facilities.
WuXi Biologics announced that its Drug Product Facility 15 (DP15), located at the company’s Fengxian site in Shanghai, achieved GMP release in April and has since moved into operational use. The facility has completed multiple engineering and GMP batches and has delivered clinical supplies to support client regulatory filings and clinical development programs.
The DP15 facility is the company’s 18th operational drug product manufacturing site within its global CRDMO network. According to WuXi Biologics, the facility was designed to meet international regulatory standards and is equipped with isolator-based aseptic filling lines supporting both liquid and lyophilized drug product manufacturing. The site also includes capabilities such as 100% fill weight checks, nitrogen overlay, low-temperature loading for lyophilization, and fill-finish support for vial sizes ranging from 2R to 20R.
WuXi Biologics stated that the facility is integrated with surrounding site operations to support the transition from development to GMP manufacturing and improve operational efficiency for clinical-stage biologics programs. The company said the facility is intended to support faster delivery timelines for client projects through integrated manufacturing operations.
“The successful GMP release of DP15 further strengthens our integrated delivery capabilities from drug substance to drug product.”
Dr. Chris Chen, CEO of WuXi Biologics
The company said its global network includes operations across China, the United States, Ireland, Germany, and Singapore, with 24 drug substance facilities and 18 drug product facilities currently in operation. WuXi Biologics also stated that by the end of 2025 it had delivered more than 2,350 drug substance batches and over 2,260 drug product batches, while completing 46 regulatory inspections globally with no critical findings or data integrity issues reported.
