China Bioanalysis Forum 2024 -- Antibody-drug conjugates (ADCs) represent a rapidly evolving area of drug development and hold significant promise. It combines the target specificity of monoclonal antibodies with the anticancer activity of small-molecule therapeutics. Method transfers occur for a number of reasons. Typically, when a program is in early clinical states, there is usually only a single lab supporting the clinical bioanalysis for the study. However, if the program expands into multiple clinical studies and multiple countries, the bioanalytical work needs may exceed the support of a single lab. Therefore, it could be necessary to establish the bioanalytical assay in other labs, including in other countries. Per M10, cross-validation is required to demonstrate how the reported data are related when multiple bioanalytical labs are involved in one study or across studies that are going to be combined or compared to support special dosing regimens, or regulatory decisions regarding safety, efficacy and labelling. ADC is a complex modality in structure. Biotransformation in vivo can lead to additional changes in drug-to-antibody ratios resulting in dynamically changing mixtures. It makes that cross-validation for ADC more challenging as compared to other biologics. This poster proposes to use in-vivo samples as an effective approach to guide the assay transfer for an ADC PK assay.

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