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WuXi XDC, a WuXi Biologics subsidiary, and a leading Contract Research, Development and Manufacturing Organization (CRDMO), is a joint venture between WuXi Biologics and the WuXi AppTec subsidiary, WuXi STA. The joint venture greatly simplifies Antibody Drug Conjugate (ADC) and other bioconjugate drug development by providing all discovery, preclinical activities, CMC development and the entire manufacturing supply chain under one company and in one centralized region. WuXi XDC provides single-source development and manufacturing platforms for small molecule linkers / payloads and biologics (e.g., monoclonal, bispecific and multispecific antibodies or other recombinant proteins) intermediates with the company’s leading bioconjugation discovery, development and manufacturing services.
The WuXi XDC one-stop service and technology platform provides for our clients an unmatched value chain for the development of ADCs and other bioconjugates including conjugated diagnostic and imaging reagents.
All activities and services performed at WuXi XDC are conducted within 1-2 hours (driving), thus providing an unprecedented geographic advantage.
Our expertise, highly-efficient value chain and geographic advantage allows us to cut the traditional antibody drug conjugate CMC development period in half. We can start with cell line development activities for generation of the antibody intermediate and finish with an IND filing for the bioconjugate drug in only 15 months!
We provide world-class expertise in both platform and novel conjugation technologies and can handle highly potent and toxic payloads. Extensive payload and linker libraries as well as a variety of mAb library generation and screening platforms are available for development candidate matrix preparation and evaluation. A complete ADC analytical development toolbox can be leveraged to select the most appropriate analytical methods for specific bioconjugate characterization, and to establish lot release and stability assay panels. We offer a full range of services including both integrated mAb, payload-linker and bioconjugate development packages and standalone CMC development and drug substance (DS) and drug product (DP) manufacturing packages just for the bioconjugate or intermediates. We extend our extensive bioconjugation services for diagnostic and imaging reagents and we also provide “ready-made” GMP-grade chemical payloads / linkers, many with an existing Drug Master File (DMF).