WuXi XDC's Singapore DP4 Facility Achieves GMP Release, Marking First Overseas Drug Product Plant
WuXi XDC announced GMP release of its first Singapore drug-product facility DP4 for bioconjugates, with annual capacity up to 8 million vials of liquid or lyophilized dosage form. From groundbreaking to GMP release in just 29 months, DP4 is the second capacity facility in Singapore after BCM3.
On August 28, 2026, WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on bioconjugates, announced that its first drug-product (DP) manufacturing facility DP4 for bioconjugates at its Singapore site has successfully achieved GMP release. This milestone represents not only a further expansion of manufacturing capacity but also a substantive upgrade of WuXi XDC's global supply network, laying a more solid foundation for continuously empowering clients and accelerating the delivery of innovative therapies to patients worldwide.
The DP4 facility is equipped with one 10 m² and two 30 m² lyophilizers, providing annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. The facility strictly adheres to GMP standards set by the US FDA, EMA and Singapore HSA, ensuring full-process compliance and product quality control throughout the entire manufacturing workflow.
The facility offers comprehensive end-to-end sterile drug-product manufacturing and packaging services covering washing and sterilization, compounding, vial washing, depyrogenation, filling, lyophilization, capping, external washing, manual and automated visual inspection, labeling and packaging. The core filling line is equipped with a state-of-the-art sterile isolator enabling 100% in-line filling-weight checking and vacuum-free stoppering technology, with filling speed up to 300 vials per minute and a camera-based vision system that performs real-time rejection of vials with missing or high-seated stoppers.
The lyophilizers employ liquid-nitrogen cooling technology with fully automated loading and unloading systems. The automated visual-inspection machine incorporates multi-color imaging, headspace oxygen detection and pulsed X-ray technology. The line is also equipped with semi-automated PUPSIT filtration, AGV automated transfer and fully automated material disinfection devices. The automated packaging line integrates single-vial and multi-vial formats for both commercial and clinical production needs, with labeling, cartoning, secondary packaging and drug traceability functions.
Built to the highest international standards, DP4 features a unique modular facility design with unidirectional flow, advanced high-potency sterile equipment, strict risk classification management, innovative single-use technologies with a comprehensive environmental monitoring system, and fully automated material transfer and disinfection systems — supporting both liquid and lyophilized sterile bioconjugates from clinical to commercial manufacturing. As WuXi XDC's first overseas drug-product facility, DP4 completed the entire process from facility construction, commissioning and qualification, aseptic processing simulation to GMP release in just 29 months — again demonstrating the 'WuXi speed'.
The on-schedule GMP release of DP4 marks the second production-capacity addition at the Singapore site, following the GMP release of the BCM3 facility in mid-August. With this milestone, Singapore can now offer end-to-end services across antibodies, bioconjugate drug substances and drug products. As the first overseas site in WuXi XDC's global network, the company is fully confident in its long-term growth and will continue to accelerate the discovery, development and manufacturing of bioconjugates worldwide through its integrated CRDMO platform — empowering global partners with more resilient supply networks and globally unified quality standards.