WuXi XDC Cayman Inc. a leading global Contract Research, Development and Manufacturing Organisation (CRDMO) focused on the bioconjugate industry, has announced that the mechanical completion of its manufacturing site at Tuas Biomedical Park in Singapore has been successfully achieved.
This milestone signifies that this manufacturing site, spanning approximately 25,000 square meters, will now officially transition into the facility C&Q (Commissioning and Qualification) stage. The Singapore site is expected to commence operations by the end of 2025 and Good Manufacturing Practice (GMP) manufacturing in 2026. Upon that, the site will offer comprehensive production capabilities from the preclinical stage to commercialisation.
According to current capacity plan, the site is anticipated to create more than 500 job opportunities and over 100 people have joined our company so far.
The Singapore site serves as a world-class, one-stop bioconjugates manufacturing centre, integrating antibody intermediates, drug substance (DS), and drug products (DP). It strictly adheres to international certification standards and utilises an advanced modular factory design. Key features include state-of-the-art antibody intermediates production lines, bioconjugate DS and DP production lines, MSAT lab, quality control, intelligent warehousing, and other utility support areas.
Equipped with cutting-edge isolator filling lines, fully automated material transfer systems, and digital production management systems, the Singapore site supports multi-level demands ranging from small-scale clinical supplies to large-scale commercial manufacturing, including up to 2,000 liters per batch of mAb/DS, and 8 million vials of DP per year. These capabilities ensure the efficient advancement of projects across various stages while maintaining adherence to the highest quality standards.
The Singapore site will be operated under the highest international quality assurance standards, fully complying with Good Manufacturing Practice (GMP) regulations established by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA).
