Efficient Method Development for Separation of Antibody Charge Variants by Ion-Exchange Chromatography

User Benefits

- Shim-pack Bio IEX ion-exchange chromatography column enables analysis of charge variants of antibodies. - LabSolutions MD can automate the entire workflow for method development, including the generation of an analysis schedule, mobile phase preparation, and data processing, thanks to specific functionalities, such as for ranking chromatograms by criteria values and for design space evaluation.

Introduction

Monoclonal antibodies and antibody-drug conjugates (ADCs), like other antibody pharmaceuticals, are produced using animal cells, which results in structural heterogeneity and impurities. Charge variants are impurities generated from the heterogeneity of C-terminal lysine, deamidation, oxidation, and other factors, that can affect the stability and efficacy of antibody pharmaceuticals. Therefore, it is important to appropriately separate, detect, and monitor charge variants for quality control purposes. This article describes how to efficiently achieve the optimal peak separation for charge variants of a monoclonal antibody using pH gradient ion-exchange chromatography and LabSolutions MD, which is dedicated software for supporting method development.

November 25, 2025 GMT