Abstract
Therapeutic proteins make up a significant proportion of the drugs currently approved or under clinical development. Most of these proteins are glycosylated, and glycosylation usually has a strong impact on both the safety and efficacy of these drugs. Therefore, efficient analytical methodologies are required to characterize these modifications. Most analytical techniques involve a separation step before optical or mass-spectrometric detection. This chapter gives an overview of the separation techniques that can be used to characterize therapeutic proteins. Different levels of analysis are considered (intact protein, subunits, glycopeptides, released glycans, or monosaccharides), depending on the stage of development of the product and the level of details that have to be obtained.
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