Development and validation of a hybrid immunoaffinity LC–MS/MS assay for quantitation of total antibody (TAb) from an antibody drug conjugate (ADC) PYX-201 in human plasma

Feng Yin,Diana Adhikari,Marlking Peay,Diego Cortes, Mohammed Garada,M. Shane Woolf,Eric Ma, Diane Lebarbenchon,William Mylott, Mike Dyszel,Shawn Harriman,Jan Pinkas

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences（2023）

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Abstract

•A hybrid immunoaffinity LC-MS/MS assay was fully validated to measure PYX–201 tAb concentrations in human K2EDTA plasma.•This assay validation followed 2018 U.S. FDA guidance and 2022 ICH M10 guidance for industry in bioanalytical method validation.•This is the first bioanalytical assay validation on tAb of the investigational ADC, PYX–201 in human plasma.•This bioanalytical LC-MS/MS assay successfully supported first-in-human (FIH) phase I clinical trial.

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Key words

Total antibody (TAb),ADC,PYX-201,Extra domain B fibronectin,Oncology,Hybrid LBA-LCMS,Human plasma,Validation

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