Singapore – September 21, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has secured GMP release for its Singapore manufacturing site at Tuas Biomedical Park, marking the bioconjugate CRDMO's first overseas facility just two and a half years after the site was announced in March 2024.
BCM3 dual-function line and DP4 drug product facility clear GMP release
The 25,000-square-meter site achieved GMP release for both its BCM3 antibody intermediate and conjugated drug substance production line and its DP4 drug product facility in August 2026. BCM3 supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances, operating under FDA, EMA and NMPA standards. A second line, BCM4, is slated for GMP release by the end of 2026 with a maximum single-batch capacity of 500 L for conjugated drug substance.
DP4 facility adds 8 million vials of annual fill-finish capacity
The DP4 facility, equipped with one 10 m2 and two 30 m2 lyophilizers, provides annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. Its filling line uses a sterile isolator with 100% in-line weight checking and a camera-based vision system for real-time rejection of defective vials, running at speeds up to 300 vials per minute. The facility, compliant with FDA, EMA and HSA standards, covers washing, compounding, filling, lyophilization, capping, inspection, labeling and packaging in a single end-to-end line.
Singapore hub joins four China sites in global dual-sourcing network
CEO Dr. Jimmy Li said the release is a key step in the company's global manufacturing footprint, with the Singapore site forming a collaborative network alongside existing operations in Wuxi, Shanghai, Hefei and Suzhou. Ms. Cindy Koh, Executive Vice President of the Singapore Economic Development Board, said the investment strengthens Singapore's capabilities in manufacturing complex new modalities. Morimatsu Pharmadule (China) CEO Li Daoquan, a strategic partner in the modular factory build, was also present at the ribbon-cutting ceremony.
Site tour draws dozens of multinational and biotech clients
Following the ceremony, dozens of multinational corporations and global biotech companies toured the site's production lines, quality control center and machinery areas, reviewing the integrated production chain spanning antibody intermediates, conjugated drug substances and drug products. WuXi XDC said the Singapore facility will now deepen integration with its domestic sites to build a multi-dimensional manufacturing network for bioconjugate industry partners.