#Singapore #GMP Certification #WuXi XDC

WuXi XDC Achieves GMP Release of BCM3 Facility in Singapore

Introduction

On August 18, 2026, WuXi XDC Cayman Inc., known for its leadership in the Contract Research, Development and Manufacturing Organization (CRDMO) sector, celebrated a major milestone. The newly completed BCM3 facility for antibody intermediates and bioconjugate drug substances in Singapore has successfully obtained GMP (Good Manufacturing Practice) release. This achievement is set to transform manufacturing processes for clients across the globe by significantly improving efficiency and adaptability to diverse production needs.

About BCM3

The BCM3 facility marks WuXi XDC's first GMP-certified site outside China. It features a unique design that accommodates dual functionalities, providing comprehensive services that span from the production of antibody intermediates to the creation of conjugated drug substances. With capabilities to handle batch sizes from as small as 200 liters up to 2,000 liters, BCM3 fully complies with commercial-scale production requirements while adhering to the highest quality control standards.

This facility is more than just a manufacturing site; it represents a strategic enhancement of WuXi XDC's global manufacturing network. By working in synergy with the existing BCM1 and BCM2 lines located in Wuxi, the BCM3 facility significantly amplifies the company's overall production capabilities in bioconjugates and antibody intermediates, ensuring that the demand from clients can be met promptly and efficiently.

Construction Journey and Challenges

The construction of the BCM3 facility was no small feat. Drawing from its vast experience in facility construction at the Wuxi site, WuXi XDC tailored its approach to address the specific climatic and operational conditions present in Singapore. Throughout the construction process, the teams faced significant challenges, particularly concerning the design and build-out of areas intended for the manufacture of high-potency and high-toxicity substances.

The BCM3 facility's layout was engineered for flexibility, enabling it to adapt to a variety of project requirements. This optimized design minimizes material transfer times and eliminates delays, thereby streamlining the manufacturing process. Impressively, the entire pathway from the initial design stage to achieving GMP certification took merely two and a half years, underscoring WuXi XDC's dedication to speed and efficiency, often referred to as