Facilitating ADC Preclinical DMPK Research with an Integrated Bioanalysis Platform

Antibody-drug conjugates (ADCs) are an exciting therapeutic modality that can target and destroy cancer cells like few other therapies. At present, 16 ADC drugs have been marketed globally, including 15 FDA-approved and one NMPA-approved ADC. However, despite its advantages, the intricate structure of ADCs—which includes a monoclonal antibody, a cytotoxic payload, and a chemical linker—makes them difficult to investigate. To address the challenges, preclinical researchers need a better approach.

In this webinar, we explore an integrated platform for preclinical DMPK bioanalysis of ADCs and how it can help characterize the pharmacokinetic (PK) profile of each of an ADC drug’s structural components. The platform incorporates a number of different testing strategies—ligand-binding assays (LBAs), liquid chromatography mass spectrometry (LC/MS), hybrid LBA-LC/MS bioanalysis—and is divided into six parts: total antibody, conjugated antibody (ADC), free payload, metabolite identification (MetID) and major metabolites, immunogenicity, and the drug antibody ratio (DAR) evaluation. We’ll dive into each part in detail, and, along the way, review several internal validation cases of DMPK research for ADCs.