ShanghaiJune 24, 2026 /PRNewswire/ — WuXi Biologics (2269.HK), a global leading Contract Research, Development, and Manufacturing Organization (CRDMO), announced that its Drug Substance Plant 17 (MFG17) at the Shanghai Fengxian Base has successfully completed its first GMP production run. The entire production process achieved zero deviations, with stable critical process parameters and yields meeting expected levels, demonstrating exceptional manufacturing processes and quality control capabilities. As the 25th drug substance plant in WuXi Biologics’ global network, MFG17 will provide scaled services for the clinical and commercial production of various biologic products.
To address diverse client needs at different stages, MFG17 is equipped with multiple single-use bioreactors (SUB), offering 9,000 liters of capacity and an annual production capability of 80-100 batches of drug substance. Additionally, while meeting GMP compliance requirements, MFG17 accommodates a variety of manufacturing processes, including fed-batch, N-1 perfusion, perfusion, intensified perfusion, and fully automated continuous production. These capabilities enhance operational efficiency and process productivity, providing high-quality manufacturing support for process scale-up and stable supply of complex molecule projects.
Meanwhile, MFG17 is advancing its digital and intelligent capabilities by systematically integrating automation, digital technologies, and infrastructure into the full value chain of biologic drug manufacturing. This transforms data, computing, and predictive capabilities into smarter operational management and more efficient production delivery, offering clients higher quality, greater flexibility, and cost-effective solutions.
The plant will work in synergy with other facilities at the Shanghai Fengxian Base, accelerating end-to-end integration of biologics from discovery to development, clinical to commercial production, and drug substance to drug product manufacturing, enabling faster and more efficient delivery of client projects.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “The successful completion of the first GMP production at MFG17 further strengthens our manufacturing capabilities. Leveraging highly flexible single-use production technologies and continuously upgraded digital and intelligent capabilities, we not only provide high-quality manufacturing support for client projects but also strive to be an extension of their capabilities, accelerating the delivery of innovative biologics to patients worldwide.”
WuXi Biologics continues to strengthen its global dual-plant strategy, supporting the coordinated supply of the same product across different manufacturing sites. This covers diverse needs such as technology transfer, commercial scale-up, and multi-regional regulatory filings, providing clients with long-term, stable, and resilient commercial supply assurance. Currently, WuXi Biologics has established 5 R&D centers, 10 development centers, and 18 manufacturing centers across China, the United States, Ireland, Germany, and Singapore, with a total of 25 drug substance plants and 18 drug product plants in operation, offering end-to-end integrated manufacturing solutions and services to global clients.
As of the end of 2025, the company has delivered over 2,350 batches of drug substance and over 2,260 batches of drug product, successfully passing 46 global regulatory authority inspections with zero critical findings and zero data integrity issues. This includes 22 inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), maintaining a 100% pass rate in FDA Pre-License Inspections (PLI). Additionally, the company has passed over 1,800 GMP quality audits from global clients, including more than 230 Qualified Person (QP) audits from the European Union, demonstrating consistent high-quality delivery across its global network.
About WuXi Biologics
WuXi Biologics (Stock Code: 2269.HK) is a global leading Contract Research, Development, and Manufacturing Organization (CRDMO). Through its open-access, integrated biologics capabilities and technology platforms, the company provides comprehensive end-to-end services to help partners discover, develop, and manufacture biologics, from concept to commercial production, accelerating global biologics R&D, reducing costs, and benefiting patients worldwide*.
Leveraging a global network connecting China, the United States, Ireland, Germany, and Singapore, WuXi Biologics brings together over 13,000 employees, including industry experts and scientists in biologics R&D, manufacturing, technological innovation, and operational excellence. With its leading technology platforms and deep expertise, the company offers efficient, cost-effective, and scalable biologics solutions tailored to diverse client needs at different stages. Furthermore, it systematically integrates digital capabilities and infrastructure into the full value chain of biologics R&D, laboratory operations, and manufacturing, transforming data, computing, and predictive capabilities into more transparent client collaboration, faster R&D processes, smarter operational management, and more efficient production delivery. As of the end of December 2025, WuXi Biologics supported a total of 945 integrated client projects, including 74 Phase III and 25 commercial manufacturing projects, with complex molecule projects accounting for over 50% of the total project portfolio.
WuXi Biologics regards sustainable development as the cornerstone of long-term business growth. The company continuously promotes green innovation technologies, providing advanced end-to-end green CRDMO solutions to global partners, while achieving outstanding results in ESG. Committed to creating shared value, the company collaborates with stakeholders to build a sustainable ecosystem, driving both social value and ecological benefits through responsible operational models, enabling synergistic empowerment across the full value chain.
For more information, please visit: www.wuxibiologics.com.
*Awarded “2026 Biologics CDMO Leadership Award” (Large CDMO Category)
*Awarded “2026 Best Contract Development and Manufacturing Organization Award” (ABEA)
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