First Steps in Characterizing Biotherapeutics

The popularity of biotherapeutics, be it already approved for use or at a research level, continues to increase. The chemical complexity of biotherapeutics, which results from their process of production from animals, cell lines, or fermentation, means that characterization is complex and encompasses a wide variety of chromatographic techniques. This quick guide will take a practical look at the three most common chromatographic techniques used for analyzing biotherapeutics, size exclusion (SEC), ion exchange (IEX), and reversed phase (RP) chromatographies. In relation to each technique we will discuss how the technique works, what it tells us, provide generic starting conditions, and highlight any particular parameters to optimize.