Understanding Process Development Of Antibody-Drug Conjugates In Preclinical And Early Phase Clinical Trials

By Reese Chung, Mycenax

Antibody-drug conjugates (ADCs) are garnering significant interest as highly targeted and potent medicines in many therapeutic areas. However, the ADC development process must balance drug efficacy and safety, requiring extensive investigations into conjugation technologies and the resulting critical quality attributes of ADCs. Leveraging a simplified and reliable platform for the development of ADC manufacturing processes can enable accelerated preclinical and clinical development.

The E-Book covers various aspects of ADC development, including understanding the process, critical quality attributes, and challenges and solutions. Each chapter provides valuable insights and information on different stages of the ADC manufacturing process. Antibody functionalization and conjugation stages are the most critical steps in determining DAR and DAR distributions; optimizing these stages is a top priority during ADC process development.

Examine an innovative platform process that is emerging as a simplified and reliable solution for ADC manufacturing processes. It offers efficient process development, purification techniques, and optimization strategies to ensure consistency and meet quality requirements. The platform aims to accelerate the development of new ADCs and improve product quality while reducing costs.