Publication / Source: Bioanalysis 8(6)
Authors: Myler H, Rangan VS, Kozhich A, Hoffpauir B, Dail D, Cummings J, Saewert M, Manney A, Liu A, Rao C, Wang J, Pillutla R, DeSilva B
The bioanalytical strategy for antibody–drug conjugates (ADC) includes multiple integrated measurements of pharmacologically relevant ADC. Methods & results: Three ligand-binding assays were validated for the measurement of total antibody, active ADC and total ADC. Accuracy and precision demonstrate %bias from -8 to 14%, %CV from 3 to 11% and total error from 3 to 21%, with >98% samples meeting incurred sample reanalysis criteria. Each assay met stability, selectivity, dilutional integrity, carry over and specificity criteria with no interference from associated metabolite/impurity. Given the active ADC assay sensitivity to payload, active ADC was used to assess drug to antibody ratio. Discussion & conclusion: Implementation of a microfluidic automated platform enabled high throughput sample analysis of multiple analytes with minimal sample processing.