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Overview

WuXi XDC: Your Single Source for Bioconjugation Development and cGMP Manufacturing

 

WuXi XDC, a WuXi Biologics subsidiary, 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 preclinical activities, holistic and integrated CMC development process and the entire supply chain under one company and in one centralized region. The joint venture combines the existing single-source development and manufacturing platforms for payload, linker and biologics (e.g., monoclonal or bispecific antibodies or other recombinant proteins) with the company’s leading bioconjugation development technology platforms and previously established drug substance and drug product GMP manufacturing facilities.

 

The WuXi XDC comprehensive technology platform provides for our clients an integrated one-stop value chain for the development of ADCs and other bioconjugates.

 

 

All activities within the WuXi XDC technology platform are conducted within 1-2 hours (driving) thus providing an unprecedented geographic-centric value chain.

 

 

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 and bioconjugate development packages and bioconjugate standalone CMC development and manufacturing packages. 

 


WuXi Biologics offers extensive GMP manufacturing for all bioconjugate intermediaries (e.g., payload, linker and antibody/proteins) as well as dedicated facilities for integrated bioconjugate drug product development solutions from development and clinical supply to commercialization. Capablities for bioconjugation manufacturing include: 

 

 

  • Preclinical drug product and toxicology material manufacturing
  • Clinical trial drug product manufacturing for Phase I/II
  • Late-stage programs (PC, PPQ, Phase III and commercial)

 

 

The functional areas include conjugation, compounding, filling, lyophilization, QC laboratory, warehouse and engineering utilities. This facility can handle a broad range of bioconjugate development and manufacturing including Antibody Drug Conjugates with SafeBridge level 4 or OEB 5 classification.

 

Our cGMP manufacturing facilities for ADCs/bioconjugates are designed to meet U.S. FDA, EMA and NMPA GMP requirements and global EHS compliance.

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