Bioanalytical Expertise for Antibody-Drug Conjugates

This document is a technical report detailing the bioanalytical expertise required for the development of antibody-drug conjugates (ADCs). It outlines the specialized equipment and methodologies employed in the analysis of ADCs, particularly focusing on pharmacokinetic (PK) and pharmacodynamic (PD) assessments in both preclinical and clinical studies. The report discusses the selection of appropriate bioanalytical platforms, including ligand binding assays (LBAs) and LC-MS/MS workflows, highlighting their advantages and disadvantages. It further describes the different types of assays necessary for evaluating ADCs, such as total-antibody assays and total conjugated ADC assays, and explains the significance of anti-drug antibodies (ADAs) in the context of ADCs. Additionally, the report emphasizes the importance of immunogenicity testing and the use of neutralizing antibody assays in clinical development. The document concludes by reaffirming the expertise and experience of Altasciences in conducting these complex bioanalytical assessments.