September 21, 2026, Singapore – WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, today held a grand GMP release ceremony for its Singapore manufacturing site at Tuas Biomedical Park. From announcing the new site in March 2024 to achieving GMP release of the BCM3 antibody intermediate and conjugated drug substance dual-function production line and the DP4 facility in August 2026, this important milestone was reached in only two and a half years. It marks the transition of WuXi XDC’s “Global Dual-Sourcing” strategy from blueprint to reality, opening a new chapter in empowering more global clients to accelerate commercial manufacturing.
At the beginning of the event, Dr. Jimmy Li, CEO of WuXi XDC, delivered opening remarks. He noted that the successful GMP release of the company’s first overseas manufacturing site is a key step in WuXi XDC’s global manufacturing footprint. Leveraging a globally leading quality system, cutting-edge innovation, and operational excellence, the company will continue to enhance the resilience and diversification of its supply system. The Singapore site will form a global collaborative network with sites in Wuxi, Shanghai, Hefei, and Suzhou, continuing to provide clients with end-to-end, one-stop CRDMO solutions for bioconjugates.
The Singapore site has a total gross floor area of approximately 25,000 square meters and serves as a core cornerstone of WuXi sXDC’s commercial production. To date, the site’s BCM3 dual-function production line and DP4 conjugated drug product facility have both successfully completed GMP release.
BCM3 features an efficient and flexible "dual-function" design, offering integrated end-to-end commercial manufacturing services from antibody intermediates to conjugated drug substances. The production line supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances. The line strictly follows international GMP standards such as FDA, EMA, and NMPA, and has established a comprehensive quality control system. In addition, the BCM4 facility is expected to achieve GMP release by the end of 2026, with a maximum single-batch capacity of up to 500 L of conjugated drug substance.
The DP4 facility is equipped with one 10 m² and two 30 m² lyophilizers, providing an annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. The facility strictly adheres to GMP standards set by the FDA, EMA and HSA. The core filling line is equipped with a state‑of‑the‑art sterile isolator, enabling 100% in‑line filling weight checking. The filling speed can reach up to 300 vials per minute, with a camera‑based vision system that performs real‑time rejection of vials with missing or high‑seated stoppers. The facility offers comprehensive end-to-end sterile drug product manufacturing and packaging services, covering tools washing and sterilization, compounding, vial washing, depyrogenation, filling, lyophilization, capping, external washing, manual visual inspection, automated visual inspection, labeling, and packaging.
The successful GMP release of the WuXi XDC Singapore site is an important milestone in the company’s history and solid support for providing end-to-end, one-stop services to more clients worldwide. In the future, the Singapore site will deeply integrate and collaborate with multiple domestic sites to build an integrated, multi-dimensional comprehensive network, continuously empowering partners and the innovative development of the bioconjugate industry.
