AAPS 2024 PHARMSCI 360

Li Qu, Ph.D. | Deputy Director, Non-GLP Bioanalysis, WuXi AppTec

Peng Li, Ph.D. | Senior Scientist, MetID, WuXi AppTec

This presentation will explore the comprehensive evaluation of Antibody-Drug Conjugates (ADCs) through integrated bioanalysis and advanced biotransformation studies. Key topics include nonclinical pharmacokinetic assessment, metabolite profiling, Drug-to-Antibody Ratio (DAR) analysis, and strategies to address ADC complexities throughout development. Attendees will gain insights into leveraging multiple analytical platforms and hybrid methods to overcome challenges in ADC drug development, facilitating the ADC drug R&D process.

Learning Objectives:

• Understand the role of integrated bioanalysis in nonclinical pharmacokinetic evaluation of ADCs.

• Learn advanced methodologies for ADC biotransformation, including metabolite profiling and DAR analysis.

• Explore strategies to overcome challenges in ADC development using comprehensive analytical approaches.