Assessing the Degradation of Biopharmaceutical Compounds by Ion-Exchange Chromatography (IEX) (CAT#: STEM-B-0402-CJ)

Introduction

All biopharmaceutical compounds are sensitive towards chemical degradation. Examples are deamidation, hydrolysis, oxidation, photo-degradation, disulfide-scrambling, and others. Chemical degradation can lead to aggregation, charge variants and/or structural changes of the drug substance and eventually impair the effectivity or safety of the therapy.

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Principle Applications Procedure Materials Notes Related Products

Principle

The technique does not require organic solvents and is therefore frequently applied to characterize proteins in their native / active form. IEX on high-performance liquid chromatography (HPLC) instruments coupled with UV-, fluorescence-, refractive index- and/or multi-angle laser light scattering (MALLS) detection.

Applications

Biopharmaceutica

Procedure

1. Sample preparation.
2. After loading an impure protein sample onto an ion exchange chromatography column, the column is washed to remove undesired proteins and other impurities, and then the protein(s) of interest is eluted using either a salt gradient or a change in pH.

Materials

• Sample: Peptides, Proteins, Vaccines, Virus-like particles
• Equipment: Resins, Chromatography membranes, Monoliths, Ion exchange column,

Notes

The charged species in buffers used for ion exchange chromatography should thus generally have the same sign as the charged species of the IEX resin.

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