- WuXi XDC has received GMP release for its BCM3 antibody intermediate and conjugated drug substance dual-function production line and DP4 facility at its Tuas Biomedical Park site in Singapore.
- The site covers approximately 25,000 square meters, with the DP4 facility capable of producing up to 8 million vials of liquid or lyophilized bioconjugates annually.
WuXi XDC has received GMP release for its manufacturing site at Tuas Biomedical Park in Singapore, covering the BCM3 antibody intermediate and conjugated drug substance dual-function production line and the DP4 facility. The company said the GMP release was completed two-and-a-half years after the new site was announced in March 2024.
The approximately 25,000-square-meter site is part of WuXi XDC’s commercial manufacturing operation. The BCM3 production line provides integrated, end-to-end commercial manufacturing services, supporting batch sizes of 200 to 2,000 liters for antibody intermediates and up to 2,000 liters for conjugated drug substances. WuXi XDC said the GMP release marks the transition of its global dual-sourcing strategy from blueprint to implementation.
The DP4 facility includes one 10-square-meter and two 30-square-meter lyophilizers. It has an annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. Filling speeds can reach up to 300 vials per minute, with a camera-based vision system used for real-time rejection.
WuXi XDC also said its BCM4 facility is expected to receive GMP release by the end of 2026. The facility will have a maximum single-batch capacity of up to 500 liters of conjugated drug substance. The company expects the Singapore site to integrate and collaborate with multiple domestic sites as it develops a broader network for partners in the bioconjugate industry.
