WuXi XDC, a Shanghai-based contract research, development and manufacturing organization (CRDMO) focused on bioconjugates, has completed its first Good Manufacturing Practice (GMP) production of bioconjugate drug substance (DS) and drug product (DP) at its Singapore facility. The Nov. 2 announcement marks the site’s transition from GMP release to manufacturing and supply of clinical batches.

The first DS batch was produced on the BCM3 facility’s dual-function production line as a clinical resupply batch. The line supports antibody intermediate batch sizes from 200 liters to 2,000 liters and conjugated drug substance batches up to 2,000 liters. Its configuration supports production of antibody intermediates and conjugated drug substances within the same facility.

The first DP batch was manufactured at the site’s DP4 facility as a clinical batch. The facility has one 10-square-meter and two 30-square-meter lyophilizers, with annual capacity of up to eight million vials of liquid or lyophilized bioconjugates. Its operations include compounding, vial washing, filling, lyophilization, inspection, labeling, and packaging.

The manufacturing activity follows the site’s GMP release in September, when WuXi XDC announced that its BCM3 production line and DP4 facility had received authorization to begin GMP manufacturing. The 25,000-square-meter site at Tuas Biomedical Park is part of the company’s global dual-sourcing strategy, which is intended to provide customers with manufacturing options across its Singapore and China operations.

WuXi XDC said the Singapore site will work with its facilities in Wuxi, Shanghai, Hefei, and Suzhou to support integrated manufacturing of bioconjugate products. The company is focused on antibody-drug conjugates and other bioconjugate therapies.