WuXi XDC Cayman Inc., a global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, has announced that the Drug Product 3 (DP3) facility at the Wuxi site has completed GMP release at the end of July.

In just 18 months, WuXi XDC has rapidly completed the advanced design, construction, equipment qualification, media fill and GMP release of the DP3 facility with high efficiency and quality, the company said in a statement.

It further added that the DP3 facility is expected to have an annual capacity of 7 million vials. Upon the DP3 operational, the current total capacity of the existing three bioconjugate DP facilities (DP1, DP2 and DP3) reaches approximately 15 million vials per year at the Wuxi site.

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. As a key part of our global capacity expansion, we are adding one state-of-the-art DP facility every year, systematically scaling our bioconjugate drug product network.”

He further added, “Going forward, WuXi XDC will maintain deep insights into industry needs, providing global customers with high-quality integrated CRDMO services. Our mission remains unwavering: to accelerate and transform the discovery, development and manufacturing of bioconjugates through a comprehensive open-access platform, enabling our global healthcare partners and benefiting patients worldwide.”

DP3 facility is constructed in accordance with the highest international standards, use of best equipment and incorporates industry-leading technologies. It features a distinctive facility design, rigorous risk classification management, advanced high-potency and sterile equipment, innovative single-use technology, and a comprehensive environmental monitoring system. DP3 facility provides manufacturing service for liquid and lyophilised sterile products, offering customers one-stop solutions from clinical to commercial manufacturing.

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. DP3 facility 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 percent 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,” it said.