Method for detecting charge variants of a monoclonal antibody

Abstract

This application discloses a method for detecting charge variants of monoclonal antibodies. The method includes preparing a test solution of the monoclonal antibody to be tested; the test solution includes the monoclonal antibody to be tested, methylcellulose solution, urea, amino acids, an amphoteric electrolyte carrier, and an isoelectric point marker; the test solution is detected using whole-column imaging capillary isoelectric focusing, and the percentage of charge variants of the monoclonal antibody to be tested is determined based on the isoelectric focusing spectrum; wherein the isoelectric point of the amino acid is similar to the isoelectric point of the boundary between the main peak and the base peak in the isoelectric focusing spectrum of the monoclonal antibody to be tested. This method can significantly improve the separation between the main peak and the base peak of the sample. It also exhibits good sensitivity and high precision, while specifically improving the separation between the main peak and the base peak, with minimal impact on the separation and ratio of the acid peak and the main peak, as well as the isoelectric point of the sample.

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