Addressing pH-Dependent Lactone–Carboxylate Interconversion to Resolve Quantitation Bias in the Bioanalysis of Exatecan-Based ADCs

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March 02,2026

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This work identifies and experimentally validates an underappreciated analytical approach in PK bioanalysis, specifically to Exatecan-based ADCs: pH-driven interconversion between lactone and carboxylate forms can create substantial and misleading discrepancies between total antibody (TAb) and conjugated antibody (ADC) measurements. We further demonstrate, with dedicated stability experiments, that a controlled acetic-acid–based acidification procedure can both harmonize analyte speciation and maintain ADC integrity, thereby restoring accurate TAb/cAb quantitation.

Addressing pH-Dependent Lactone–Carboxylate Interconversion to Resolve Quantitation Bias in the Bioanalysis of Exatecan-Based ADCs

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