Comparison of Innovator and Biosimilar Monoclonal Antibodies by Peptide Mapping Using HPLC Coupled to Time-of-Flight Mass Spectrometry

摘要

Effective characterization of innovator/biosimilar pairs with LC/MS/MS peptide mapping and differential software tools. Oxidation and deamidation levels between the innovator and biosimilar mAbs were assessed by comparing specific peptides. The analyses results showed that the innovator/biosimilar had similar deamidation levels while the biosimilar showed slightly more oxidation as compared to the innovator.