WuXi XDC Secures GMP Release for Singapore Manufacturing Site

Editor’s Take: The Singapore site can now able to integrate and collaborate with other domestic sites in WuXi XDC’s realm.

WuXi XDC held a good manufacturing practice (GMP) release ceremony for its manufacturing site at Tuas Biomedical Park in Singapore. The GMP designation applies to the site’s BCM3 antibody intermediate and conjugated drug substance dual-function production line, and DP4 facility.

Specs on Singapore

The Singapore site is a cornerstone of WuXi XDC’s commercial manufacturing operation, according to the company. It covers approximately 25,000 square meters.

A global CRDMO, WuXi XDC noted the GMP release happened in two-and-a-half years, since the new site’s March 2024 announcement.

Symbolically, WuXi XDC says this marks a transition of the company’s “global dual-sourcing” strategy from blueprint to reality.

What GMP Release Means

Concerning the two separate components of the GMP release, the BCM3 dual-function production line offers integrated, end-to-end commercial manufacturing services. It supports batch sizes from 200 to 2000 L for antibody intermediates; up to 2000 L for conjugated drug substances.

WuXi XDC says a BCM4 facility should additionally get GMP release by the end of 2026. This will have a maximum single-batch capacity of up to 500 L of conjugated drug substance.

As for the DP4 facility, it has one 10 m² and two 30 m² lyophilizers. This permits an annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. Filling speed can reach up to 300 vials per minute, with a camera-based vision system performing real-time rejection.

WuXi XDC Making Headlines

This is the second major news item for WuXi XDC in less than a week. On Sept. 17, the company announced an out-licensing collaboration with Ona Therapeutics for a proprietary payload-linker technology platform.

WuXi XDC expects the Singapore site to integrate and collaborate with multiple domestic sites in the future. This, the company says, will help it build a multi-dimensional, comprehensive network that empowers partners in the bioconjugate industry.