Wuxi XDC, a leading global contract development and manufacturing organization (CDMO) specializing in bioconjugates, has announced the mechanical completion of its new manufacturing site at Tuas Biomedical Park in Singapore, spanning about 25,000 square meters. The site is moving into the commissioning and qualification stage and is expected to start operations by the end of 2025, with Good Manufacturing Practice (GMP) manufacturing beginning in early 2026. This facility will support the full bioconjugate production process, from preclinical stages to commercialization, offering end-to-end contract research, development, and manufacturing organization (CRDMO) services.
The Singapore site is a key part of WuXi XDC’s global “Dual-Sourcing” strategy, complementing its other sites in Wuxi, Changzhou, and Shanghai. The facility incorporates advanced modular factory designs and cutting-edge production lines for antibody intermediates, drug substances, and drug products. It features automated material transfer, intelligent warehousing, and digital management systems, with capacities covering clinical to commercial scales, including 2,000 liters per batch bioconjugate drug substances and up to 8 million vials of drug products annually.
This site will operate under strict international quality standards, including compliance with GMP regulations set by the US FDA, European Medicines Agency, and China’s NMPA. It also emphasizes sustainability, employing eco-friendly materials, recycling, and waste management to support environmental, social, and governance (ESG) goals.
(Source: BioSpectrum Asia, PR Newswire)