ShanghaiMay 27, 2026 /PRNewswire/ — WuXi Biologics (2269.HK), a global leading Contract Research, Development, and Manufacturing Organization (CRDMO), announced that its Drug Product Facility 15 (DP15) at the Shanghai Fengxian base received GMP clearance in April this year. It has recently successfully completed multiple engineering and GMP batches, delivering clinical samples to meet client submission and clinical supply needs. This marks the 18th drug product manufacturing facility globally put into operation by WuXi Biologics.
The layout and production line configuration of DP15 are fully aligned with international regulatory standards, while also addressing the flexibility and efficiency requirements of clinical-stage projects. On this basis, DP15 is equipped with an advanced isolator filling line, capable of producing both liquid and lyophilized formulations. It features 100% fill weight inspection, nitrogen flushing protection during filling, and low-temperature loading for lyophilization, offering filling solutions for multiple vial sizes ranging from 2R to 20R. This facility will work in efficient synergy with other production facilities at the Shanghai Fengxian base, accelerating the entire process from drug development to GMP production, significantly speeding up client project delivery.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “The successful GMP clearance of DP15 further strengthens our integrated end-to-end capabilities from drug substance to drug product. Leveraging WuXi Biologics’ global CRDMO network, we will help clients shorten technology transfer timelines, enhance project execution efficiency, and steadily advance their key development milestones, empowering more innovative biologics to accelerate patient access.”
These capabilities are underpinned by WuXi Biologics’ long-established global integrated service system. The company has deployed 5 R&D centers, 10 development centers, and 18 manufacturing centers across China, the United States, Ireland, Germany, and Singapore, with a total of 24 drug substance facilities and 18 drug product facilities in operation, providing clients worldwide with end-to-end integrated manufacturing solutions and services. 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 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 smoothly passed over 1,800 GMP quality audits from global clients, including more than 230 Qualified Person (QP) audits from the EU, demonstrating its consistent high-quality delivery capability across its global network.
Addressing the varying needs of biologics from clinical development to commercial launch, WuXi Biologics has built a comprehensive and mature drug product capability system. Leveraging its robust global network, the high-concentration formulation platform WuXiHigh™, integrated hyaluronidase co-formulation services, and large-volume wearable device solutions, the company offers mainstream delivery forms including liquid and lyophilized vial formulations, pre-filled syringes (PFS), dual-chamber cartridge injectors (DCC), and various safety and automated combination products. These services are synergized and operated with excellence across multiple bases in Wuxi, Suzhou, Shanghai, Hangzhou, Chengdu, Singapore, and New Jersey, USA.
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 platform and technology capabilities, 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.
Relying on 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 and 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 meet client needs at different stages. Furthermore, the company systematically integrates digital capabilities and infrastructure into the full value chain of biologics R&D, lab operations, and manufacturing, transforming data, computing, and predictive capabilities into a more transparent client collaboration experience, faster R&D processes, smarter operational management, and more efficient production delivery. As of the end of December 2025, WuXi Biologics was supporting 945 integrated client projects, including 74 Phase III and 25 commercial manufacturing projects, with complex molecules 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 global partners with advanced end-to-end green CRDMO solutions, while achieving outstanding results in ESG. Upholding the value of creating shared value, the company works 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.
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