ABSTRACT

Two-dimensional liquid chromatography (2D-LC) is an analytical tool that has a lot to offer to scientists looking for ways to effectively and efficiently address the challenges associated with analysis of monoclonal antibodies (mAbs) and related proteins. This chapter briefly reviews the main principles of 2D-LC and discusses some aspects of 2D separations that are especially important in the analysis of mAbs and related materials. Characterization and analysis of mAbs and related therapeutic proteins are very challenging from an analytical point of view. This is mainly because of the large size of these molecules and the importance of small differences between molecules that are otherwise chemically identical and because of the inherent heterogeneity of these materials that reflects the biosynthetic processes that produce them. MAbs and related products are the fastest-growing class of therapeutics for human use.