WuXi XDC Completes GMP Release of New DP3 Facility

COMPANY PROFILE
  • WuXi XDC has completed the GMP release of its DP3 drug product facility at the Wuxi site.
  • The site adds 7 million vials of annual capacity, bringing the total to 15 million across three facilities.

WuXi XDC has announced the successful GMP release of its Drug Product 3 (DP3) facility at its Wuxi site, marking a major milestone in its global bioconjugate manufacturing expansion. The facility was completed in just 18 months and adds an additional 7 million vials to the company’s annual capacity, bringing the total to approximately 15 million vials across its DP1, DP2, and DP3 facilities.

The company, a global CRDMO with a focus on the bioconjugate industry, highlighted that DP3 was constructed to the highest international standards. It includes high-potency and sterile equipment, single-use technologies, and advanced environmental monitoring systems. The facility supports both liquid and lyophilized sterile products, offering end-to-end manufacturing solutions from clinical development to commercial scale.

Located in Wuxi, China, the DP3 facility incorporates automated processes including 100% online weight checks, robotic tray packaging, and high-speed vial filling at rates of up to 300 vials per minute. It complies with GMP standards from regulatory authorities, including the FDA, EMA, and NMPA.

Dr. Jimmy Li, CEO of WuXi XDC, stated: “The successful GMP release of DP3 facility marks not only another milestone for WuXi XDC, but also a new beginning towards pursuing higher goals.” He emphasised the company’s strategy to build one advanced DP facility per year as part of its global expansion.

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