- WuXi XDC has achieved GMP release for its BCM3 dual-function production line at its Singapore site, covering antibody intermediates and conjugated drug substances.
- The line supports commercial-scale batches of up to 2,000 L and is the company’s first overseas GMP-released facility.
WuXi XDC Cayman Inc. has achieved GMP release for its BCM3 dual-function production line at its Singapore site, expanding the company’s global manufacturing capacity for bioconjugates. The line provides integrated commercial manufacturing services for antibody intermediates and conjugated drug substances.
BCM3 supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances. The facility is designed to support different projects through a flexible, multi-purpose layout and includes manufacturing areas for high-potency and high-toxicity materials. WuXi XDC said the facility was completed from design through GMP release in two and a half years.
The Singapore production line will operate as part of WuXi XDC’s global manufacturing network alongside its BCM1 and BCM2 lines in Wuxi, China. The company said the two sites will work together to increase capacity and provide flexibility for commercial manufacturing requirements.
WuXi XDC said construction of the Singapore facility began following its announcement in March 2024, with mechanical completion in June 2025 followed by commissioning and qualification. The company plans to achieve GMP release for the site’s DP4 drug product filling line by the end of August 2026.
The company said the Singapore and Wuxi facilities will support its “Global Dual-Sourcing” strategy by combining global manufacturing capacity with local responsiveness.
