WuXi XDC, a Shanghai-based contract research, development and manufacturing organization (CRDMO) focused on bioconjugates, has received Good Manufacturing Practice (GMP) release for its Singapore manufacturing site at the Tuas Biomedical Park.

The site’s BCM3 dual-function production line and DP4 drug product facility have both received GMP release. BCM3 supports commercial production of antibody intermediates in batch sizes from 200 liters to 2,000 liters and conjugated drug substances in batches up to 2,000 liters. The company said BCM4, with capacity for up to 500 liters of conjugated drug substance per batch, is expected to receive GMP release by the end of 2026.

DP4 is equipped with one 10-square-meter and two 30-square-meter lyophilizers and has annual capacity for up to eight million vials of liquid or lyophilized bioconjugates. Its sterile filling line can operate at up to 300 vials per minute and includes automated fill-weight checks and camera-based inspection. The facility also provides compounding, filling, lyophilization, inspection, labeling, and packaging.

The GMP release completes a development process that began with WuXi XDC’s announcement of the Singapore site in March 2024. The 25,000-square-meter facility reached mechanical completion in July 2025, with the company then targeting operations by the end of 2025 and GMP manufacturing in early 2026.

In August 2026, WuXi XDC received GMP release for BCM3, marking its first overseas GMP-released manufacturing line. The CRDMO subsequently received GMP release for DP4, completing the site's initial drug substance and drug product manufacturing capabilities.

The Singapore site is part of WuXi XDC’s global dual-sourcing strategy, operating alongside manufacturing facilities in China. The company said the network is intended to provide customers with manufacturing options across multiple sites and support production from antibody intermediates through conjugated drug substances and drug products.