Biopharmaceuticals offer great hope in treating medical conditions which are currently poorly served at best by traditional pharmaceuticals. It is estimated that there are over 400 biopharmaceuticals in clinical trials for in excess of 200 disease areas. The enhanced complexity and variability that comes from the size of biopharmaceuticals, allied with the intricacy of the production process, mean chromatography is employed to a much greater extent during production and release testing.
Commonly reversed phase (RP), hydrophilic interaction (HILIC), ion exchange (IEX), and size exclusion (SEC) chromatographic modes will be combined to allow full characterization of these complex biomolecules. The following article will introduce the fundamentals of biopharmaceutical analysis and cover the use of reversed phase HPLC in the analysis of biomolecules.