WuXi XDC, a Shanghai, China-based contract research, development and manufacturing organization (CRDMO), has received Good Manufacturing Practice (GMP) release for its BCM3 dual-function production line at its Singapore site, enabling commercial manufacturing of antibody intermediates and drug substances for bioconjugates.

According to the announcement, the facility is WuXi XDC’s first overseas GMP-released manufacturing line and is designed to provide production from antibody intermediates through conjugated drug substances. BCM3 supports batch sizes of 200 liters to 2,000 liters for antibody intermediates and up to 2,000 liters for conjugated drug substances.

The production line will operate as part of WuXi XDC’s global manufacturing network alongside its BCM1 and BCM2 lines in Wuxi, China. The company said the Singapore and Wuxi sites will provide dual-site manufacturing capacity as part of its global dual-sourcing strategy.

WuXi XDC said the BCM3 facility incorporates multipurpose manufacturing areas and was designed to support high-potency and high-toxicity production. The company completed construction, commissioning, and qualification and GMP release within two and a half years following the Singapore site announcement in March 2024.

The company also plans to bring a drug product filling line, designated DP4, to GMP release by the end of August 2026, according to the announcement.

The Singapore facility expansion follows WuXi XDC’s strategic collaboration with Earendil Labs announced earlier this year. Under the agreement, WuXi XDC granted Earendil an exclusive global license to its payload-linker technology platform and will provide development and manufacturing services for ADC components.