Journal of Industrial Biotechnology

Original Article Pages 7-9

Advance Analytical Approach to Characterize Charge Variants in Monoclonal Antibodies

Authors: Bhatt Mithun, Mehta Kavit, Bhatt Keyur and Shekhawat Rakesh

Abstract: Post-translational modifications induce variations of monoclonal antibodies charge distribution that can potentially affect their biological activity. The characterization and the monitoring of these charge variants are critical quality requirements to ensure stability, process consistency and product quality. Charge variants are usually characterized by preparative ion exchange chromatography, collection of fractions and subsequent reverse-phase liquid chromatography with mass spectrometry analysis

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