Analysis of protein modifications in biopharmaca by capillary electrophoresis and high-performance liquid chromatography : monitoring deamidation, charge variant distribution, and PEGylation

This thesis focuses on the analysis of protein modifications and protein isoforms in biopharmaceuticals. It evaluates the potential of HPLC-UV, HPLC-ESI-MS, CE-UV and CE-ESI-MS methods, when optimized and used together with specific enzymatic treatments, for characterizing protein modifications like deamidation, modifications leading to a shift in the charge pattern, and on PEGylation.