WuXi Biologics announced that its Drug Product Facility 15 (DP15), located at the company's Fengxian site in Shanghai, achieved GMP release in April. The facility has since progressed seamlessly into operation, completing multiple engineering and GMP batches, delivering clinical supplies to support the client's regulatory filings and clinical development needs. The DP15 facility is the 18th operational drug product facility in WuXi Biologics' global network.
Designed and built to meet international regulatory standards, DP15 delivers the flexibility and operational efficiency required for clinical-stage programs. The facility is equipped with advanced isolator-based aseptic filling lines, enabling both liquid and lyophilized drug product (DP) manufacturing, and features multiple advanced capabilities ? including 100% fill weight check, nitrogen overlay, and low-temperature loading for lyophilization. Fill-finish solutions are provided for a variety of vial sizes, ranging from 2R to 20R.
Fully integrated with surrounding site operations, DP15 is positioned to further accelerate the transition from development to GMP manufacturing, and drive faster, more efficient delivery for client programs. These capabilities are built upon WuXi Biologics' well-established, globally integrated service platform. The company operates across China, the United States, Ireland, Germany, and Singapore, with 5 research centers, 10 development centers, and 18 manufacturing sites, including 24 drug substance facilities and 18 drug product facilities currently in operation, providing end-to-end integrated solutions and services for global partners. By the end of 2025, WuXi Biologics has delivered over 2,350 drug substance batches and over 2,260 drug product batches, and passed 46 regulatory inspections worldwide, including 22 inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), with a 100% success rate, no critical findings, and no data integrity issues.
In addition, the company has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons, demonstrating consistent high-quality delivery across its global network. WuXi Biologics has established a comprehensive and robust drug product capability to address the evolving needs of biologics across clinical development and commercial-scale manufacturing. Leveraging its global network and advanced technologies, including the WuXiHigh?, hyaluronidase co-formulation, and large-volume device solutions, the company offers a full range of delivery formats, including liquid and lyophilized vial formulations, pre-filled syringes (PFS), dual-chamber cartridges (DCC), and a variety of safety and automated combination products.
These capabilities are supported by coordinated operations across multiple global sites, spanning Wuxi, Suzhou, Shanghai, Hangzhou, Chengdu, Singapore, and Cranbury (New Jersey, USA).
