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WuXi Biologics Achieves GMP Release of 18th Drug Product Facility, Advancing Integrated Drug Substance to Drug Product Capabilities
WuXi Biologics Achieves GMP Release of 18th Drug Product Facility, Advancing Integrated Drug Substance to Drug Product

About this update from Wuxi Biologics (cayman) Inc.
SHANGHAI, May 27, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), 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.Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful GMP release of DP15 further strengthens our integrated delivery capabilities from drug substance to drug product. Leveraging our global CRDMO network, we will continue to enable clients to shorten technology transfer timelines, enhance execution efficiency, and advance key development milestones, ultimately accelerating the delivery of innovative biologics to patients worldwide."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 worl...
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