Collision Induced Unfolding of Intact Antibodies, Biotherapeutics and Biosimilars: Rapid Characterization of Disulfide Bonding Patterns and Structures

摘要

We have developed a novel IM-MS and CIU approach that can rapidly characterize both antibody disulfide bonding patterns and disulfide bonding numbers. This CIU method is validated by reproducibility tests, statistical analysis and control experiments. The similarity between a therapeutic antibody innovator and its biosimilar is evaluated by this IM-MS and CIU method, and we find these biotherapeutics to be highly similar though small differences exsit in primary structures With protocol modifications, we aim to apply this IM-MS and CIU approach to rapidly analyze biotherapeutics.