Comprehensive characterization of monoclonal antibody by Fourier transform ion cyclotron resonance mass spectrometry.

ABSTRACT: The pharmaceutical industry's interest in monoclonal antibodies (mAbs) and their derivatives has spurred rapid growth in the commercial and clinical pipeline of these effective therapeutics. The complex micro-heterogeneity of mAbs requires in-depth structural characterization for critical quality attribute assessment and quality assurance. Currently, mass spectrometry (MS)-based methods are the gold standard in mAb analysis, primarily with a bottom-up approach in which immunoglobulins G (IgGs) and their variants are digested into peptides to facilitate the analysis. Comprehensive characterization of IgGs and the micro-variants remains challenging at the proteoform level. Here, we used both top-down and middle-down MS for in-depth characterization of a human IgG1 using ultra-high resolution

SUBMITTER: Jin Y 

PROVIDER: S-EPMC6343775 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature