A Novel Conjugation Technology that Generates ADCs with a Narrowly Distributed DAR
Conventional conjugation methods result in heterogeneous ADC products due to a wide drug-to-antibody ratio (DAR) distribution. Over the last decade, many site-specific conjugation technologies have been developed to address this issue, yet the improved homogeneity usually comes with a cost and other technical challenges. To address these concerns, WuXi XDC developed the novel WuXiDARx™ technology platform, featuring a myriad of benefits for ADC development and manufacturing. This webinar will outline those key elements that result in ADCs generated with ideal developability characteristics and strong in vitro and in vivo profiles when compared to reference ADCs generated using other conjugation approaches. The enhanced preclinical advantages of the WuXiDARx ADCs may lead to better clinical efficacy and safety and thus far, six ADC molecules generated using one of the WuXiDARx platforms (WuXiDAR4™) have finished large-scale GMP runs and entered phase I clinical trials. Multiple case studies and data comparing the ADC quality attribute profiles of WuXiDARx-generated ADCs will be presented.
Key Learning Objectives:
- Understand current challenges in the discovery and development of Antibody Drug Conjugates (ADCs) including the ability to establish ADC molecules with a narrowly distributed drug-to-antibody ratio (DAR)
- Difficulties and challenges associated with current methodologies for establishing ADCs with consistent and homogeneous DAR
- Introduction of the WuXiDARx technology platform that reliably generates homogeneous DAR for the most clinically validated DAR formats (DAR2, DAR4, DAR6)
Qirui Fan, Ph.D., Associate Director, New Technology Development & Business Support, WuXi XDC, A WuXi Biologics Subsidiary