WuXi XDC boosts sterile drug product capacity with new China facility

WuXi XDC Cayman, a global contract research, development and manufacturing organization focused on bioconjugates, has completed GMP release of its new DP3 facility in Wuxi, China, the company announced. The site is expected to add seven million vials per year to the company's sterile drug product manufacturing capacity.

Headquartered in China, WuXi XDC said the DP3 facility was completed in just 18 months, encompassing design, construction, equipment qualification, media fill and GMP readiness. With DP3 now operational, WuXi XDC’s total bioconjugate drug product capacity at the Wuxi site reaches approximately 15 million vials annually across three facilities (DP1, DP2 and DP3).

The company said the DP3 facility was built to meet FDA, EMA and NMPA GMP requirements and integrates several advanced manufacturing features. These include automated disinfection, high-speed filling up to 300 vials per minute, non-vacuum stoppering, 100% online weight checks, robotic packaging and traceability functions.

According to the company, DP3 offers both liquid and lyophilized sterile drug product manufacturing services. It is equipped to support clinical and commercial production through single-use technology and integrated environmental monitoring.

WuXi XDC said it plans to add one new sterile drug product facility each year as part of its ongoing global expansion strategy. One of these projects is a 25,000-square-meter bioconjugates manufacturing site in Singapore, which the company said reached mechanical completion in July. The site is expected to begin operations by the end of 2025 and GMP manufacturing in early 2026.