ANALYSIS OF ANTIBODY DRUG CONJUGATES BY BEAD-BASED AFFINITY CAPTURE AND MASS SPECTROMETRY

摘要

Methods to detect, characterize,and quantitate biological samplesafter administration of antibodyconjugates, antibody-drug conjugates ofFormula I, antibodies, and fragmentsand metabolites thereof, by immunoaffinitybead separation, chromatography,and mass spectrometry aredisclosed. Ab-(L-D)p wherein Ab is anantibody; D is a drug moiety; L is a linkercovalently attached to Ab, and covalentlyattached to D; and p is 1, 2, 3, 4,5, 6, 7, or 8.