Method Development for Separating Charge Variants of Antibody-Drug Conjugates by Ion- Exchange Chromatography

User Benefits

- Shim-pack Bio IEX ion-exchange chromatography column enables analysis of charge variants of antibody-drug conjugates (ADCs). - LabSolutions MD can automate the entire workflow for method development, including the generation of an analysis schedule, mobile phase preparation.

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, which are impurities generated from the heterogeneity of C-terminal lysine, deamidation, oxidation, and other causes, can impact the stability and efficacy of antibody pharmaceuticals. Therefore, it is important to appropriately separate, detect, and monitor charge variant peaks for quality control purposes. This article describes using LabSolutions MD, which is dedicated software for supporting method development, to efficiently optimize peak separation between ADC charge variants when using pH gradient ion-exchange chromatography.

December 16, 2025 GMT