Performance of an Affinity Mass Spectrometric Method for Characterizing Antibody Drug Conjugates in Plasma/Serum

摘要

A novel affinity mass spectrometric method was developed for measuring the relative amounts of ADC components with different drug-to-antibody ratios (DAR) in plasma or serum. The affinity MS method accurately determined the expected ADC compositions in the concentration range of 1.3 to 50 (mu)g/mL in plasma or serum. No significant matrix effects were observed in plasma or serum across different species. The affinity MS method was successfully used to obtain the DAR distribution of ADCs in vivo.