WuXi XDC Cayman Inc (HK:2268), a China-based global Contract Research, Development and Manufacturing Organisation (CRDMO) focused on the bioconjugate industry, announced on Monday that the Drug Product 3 (DP3) facility at its Wuxi site completed GMP release at the end of July.

In 18 months, WuXi XDC has completed the advanced design, construction, equipment qualification, media fill and GMP release of the DP3 facility, which is expected to have an annual capacity of 7 million vials. Once DP3 is operational, the total capacity of the three bioconjugate DP facilities (DP1, DP2 and DP3) will reach approximately 15 million vials per year at the Wuxi site.

Wuxi says that the DP3 facility meets the highest international quality standards and fully complies with GMP regulations from the FDA, EMA and NMPA, ensuring process compliance and product quality. It integrates material disinfection, cleaning and sterilisation, formulation, filling, lyophilisation, capping, external washing, visual inspection and packaging. The filling process features automatic emptying DS from bag, 100% online weight check, non-vacuum stoppering and high-speed filling up to 300 vials per minute. A dual-camera system detects the stopper height and rejects products with missing or high stopper products online. The robotic tray packaging and automated packaging line provides labelling, carton packaging, end of line packaging and traceability, enabling efficient and precise manufacturing.