LC-MS based case-by-case analysis of the impact of acidic and basic charge variants of bevacizumab on stability and biological activity.

ABSTRACT: The present study investigates the impact of charge variants on bevacizumab's structure, stability, and biological activity. Five basic and one acidic charge variants were separated using semi-preparative cation exchange chromatography using linear pH gradient elution with purity > 85%. Based on the commercial biosimilar product's composition, two basic variants, one acidic and the main bevacizumab product, were chosen for further investigation. Intact mass analysis and tryptic peptide mapping established the basic variants' identity as those originating from an incomplete clipping of either one or both C-terminal lysine residues in the heavy chain of bevacizumab. Based on peptide mapping data, the acidic variant formation was attributed to deamidation of asparagine residue (N84), oxidatio

SUBMITTER: Singh SK 

PROVIDER: S-EPMC7846745 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature