WuXi XDC Singapore Site BCM3 Achieves First Overseas GMP Release
en.Wedoany.com Reported - WuXi XDC (WuXi XDC Cayman Inc., stock code: 2268.HK) recently announced that the BCM3 dual-function production line (for antibody intermediates and bioconjugate drug substances) at its Singapore site has successfully obtained GMP release. This facility is WuXi XDC's first overseas GMP-released facility, marking a new phase in the global capacity expansion of this bioconjugate contract research, development, and manufacturing organization (CRDMO).
The BCM3 production line features a "dual-function" design, providing integrated end-to-end commercial manufacturing services from antibody intermediates to conjugated drug substances. The line supports batch sizes ranging from 200 liters to 2,000 liters for antibody intermediates, with conjugated drug substance batch sizes up to 2,000 liters, meeting commercial-scale requirements and adhering to a rigorous quality control system. As part of WuXi XDC's global manufacturing network, BCM3 will operate in synergy with the BCM1 and BCM2 production lines at the Wuxi site, enhancing overall capacity for antibody intermediates and conjugated drug substances.
During construction, WuXi XDC drew on the facility construction experience of the Wuxi site while making adaptive adjustments for local conditions in Singapore. The project delivered high-standard cleanroom areas and supporting utility systems. The team overcame significant challenges in the design and construction of high-potency, high-toxicity production areas during the construction phase. The flexible multi-purpose layout enables BCM3 to accommodate varying project requirements, and optimized internal process design has reduced material transfer and waiting times. The entire process, from facility design to GMP release, was completed in just two and a half years.
Dr. Jimmy Li, Chief Executive Officer of WuXi XDC, stated that the successful GMP release of the first overseas facility is a significant milestone in the company's global manufacturing strategy, and the company has received congratulations from global clients on this GMP release. Leveraging the synergistic advantages of the "China + Singapore" dual-site model, the company can not only enhance its flexibility in responding to diverse orders but also provide clients with a solid foundation for commercial manufacturing capacity. He also noted that, looking ahead, WuXi XDC will continue to deliver high-quality integrated services, create value for global clients, and drive the high-quality development of the bioconjugate industry.
The construction journey of the Singapore site began with the site announcement in March 2024, achieved mechanical completion in June 2025, followed by commissioning and qualification (C&Q), and now the GMP release of BCM3. According to subsequent plans, DP4 (drug product filling line) is expected to achieve GMP release by the end of August 2026. Under the "Global Dual-Sourcing" strategy, the Singapore and Wuxi sites will strengthen integration and collaboration, building a manufacturing network that combines global service with local responsiveness.
