WuXi XDC Cayman Inc. announced on June 30 the successful mechanical completion of its manufacturing facility at Tuas Biomedical Park in Singapore, representing a significant milestone in the company's global bioconjugate manufacturing expansion. The 25,000 square meter facility will now transition into the Commissioning and Qualification (C&Q) stage, with operations expected to begin by the end of 2025 and Good Manufacturing Practice (GMP) manufacturing commencing in 2026.
Strategic Global Expansion
The Singapore facility serves as a cornerstone of WuXi XDC's "Global Dual-Sourcing" strategy, complementing the company's existing manufacturing network in Wuxi, Changzhou, and Shanghai. Dr. Jimmy Li, CEO of WuXi XDC, emphasized the strategic importance of this development: "The rapid mechanical completion of our Singapore site marks a critical pillar in our 'Global Dual-Sourcing' strategy. This global site will form a worldwide network alongside our Wuxi, Changzhou, and Shanghai sites, delivering end-to-end CRDMO services to global customers."
The facility is anticipated to create more than 500 job opportunities, with over 100 people already joining the company during the construction phase.
Advanced Manufacturing Capabilities
The Singapore site functions as a comprehensive bioconjugates manufacturing center, integrating production of antibody intermediates, drug substance (DS), and drug products (DP). The facility features state-of-the-art production lines, MSAT laboratory, quality control systems, intelligent warehousing, and utility support areas.
Key manufacturing specifications include:
- Up to 2,000 liters per batch capacity for monoclonal antibody/drug substance production
- 8 million vials of drug product manufacturing capacity annually
- Cutting-edge isolator filling lines
- Fully automated material transfer systems
- Digital production management systems
The facility's modular design supports multi-level demands ranging from small-scale clinical supplies to large-scale commercial manufacturing, ensuring efficient project advancement across various development stages.
Regulatory Compliance and Quality Standards
The Singapore facility will operate under the highest international quality assurance standards, maintaining full compliance with Good Manufacturing Practice (GMP) regulations established by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA). This comprehensive regulatory compliance enables seamless global product release throughout the production process.
Environmental Sustainability
The facility incorporates environmentally friendly practices, utilizing certified eco-friendly products and implementing strict recycling and waste disposal systems. These sustainability measures align with WuXi XDC's commitment to enhancing ESG management standards.
Company Background
WuXi XDC Cayman Inc. (stock code: 2268.HK) operates as a globally recognized contract research, development, and manufacturing organization (CRDMO) specializing in bioconjugates. The company provides innovative conjugation and payload-linker technologies for next-generation antibody-drug conjugate (ADC) development, offering comprehensive services from clinical to commercial manufacturing stages.
