Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization
Koen Sandra1, Isabel Vandenheede1, Pat Sandra1
1Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium.
Abstract:
Protein biopharmaceuticals such as monoclonal antibodies and therapeutic proteins are currently in widespread use for the treatment of various life-threatening diseases including cancer, autoimmune disorders, diabetes and anemia. The complexity of protein therapeutics is far exceeding that of small molecule drugs; hence, unraveling this complexity represents an analytical challenge. The current review provides the reader with state-of-the-art chromatographic and mass spectrometric tools available to dissect primary and higher order structures, post-translational modifications, purity and impurity profiles and pharmacokinetic properties of protein therapeutics.
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