WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG17 drug substance facility located at the Shanghai Fengxian site has successfully completed its first GMP production campaign. The manufacturing process execution was completed with zero deviations, while critical process parameters remained stable and yields reached expected levels, demonstrating robust process performance and strong execution capabilities. As the 25th drug substance manufacturing facility within WuXi Biologics' global network, MFG17 is designed to provide scalable manufacturing services for a broad range of biologics across both clinical and commercial stages.

To meet the diverse needs of projects at different development stages, MFG17 is equipped with multiple single-use bioreactors (SUBs), with a total manufacturing capacity of 9,000 liters for 80-100 batches annually. While adhering to global regulatory requirements, MFG17 offers both flexibility and process adaptability, supporting a wide variety of process modes, including fed-batch, N-1 perfusion, perfusion, intensified perfusion, and fully automated continuous manufacturing. These capabilities enhance operational efficiency and process productivity, while enabling robust scale-up and reliable supply for complex biologics.

MFG17 is also advancing its digitalization strategy by systematically implementing automation, digital technologies, and advanced infrastructure across the manufacturing value chain. By transforming data, computation, and predictive modelling capabilities into smarter operational management and higher production efficiency, providing clients cost-competitive manufacturing solutions.

The facility will work in close synergy with other operations at the Fengxian site, accelerating end-to-end integration from discovery to development, from clinical to commercial manufacturing, from drug substance to drug product, enabling faster and more efficient project delivery.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful completion of the first GMP production at MFG17 further strengthens our manufacturing capabilities. Leveraging highly flexible single-use technologies and continuously advancing digital capabilities, we not only provide high-quality manufacturing support for our customers, but also serve as an extension of their capabilities, empowering global partners to accelerate the delivery of innovative biologics to patients worldwide."

WuXi Biologics continues to enhance its global dual-sourcing strategy to support technology transfer, scale-up, and multi-regional registration, providing long-term, reliable, and resilient commercial supply. The company operates across China, the United States, Ireland, Germany, and Singapore, with 5 research centers, 10 development centers, and 18 manufacturing sites, including 25 drug substance facilities and 18 drug product facilities currently in operation, providing end-to-end integrated solutions and services for global partners.

As 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 an additional demonstration of consistent high-quality delivery across its global network, the company has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons.