title: Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization.
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.
authors.affiliation: Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium. Electronic address: koen.sandra@richrom.com.
authors.forename: Koen
authors.initials: K
authors.lastname: Sandra
authors.affiliation: Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium.
authors.forename: Isabel
authors.initials: I
authors.lastname: Vandenheede
authors.affiliation: Research Institute for Chromatography (RIC), President Kennedypark 26, 8500 Kortrijk, Belgium.
authors.forename: Pat
authors.initials: P
authors.lastname: Sandra
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000627:therapeutic use; D001702:Biopharmaceutics / Q000379:methods* / Q000639:trends*; D002853:Chromatography, Liquid; D006801:Humans; D013058:Mass Spectrometry; D011499:Protein Processing, Post-Translational; D011506:Proteins / Q000032:analysis* / Q000737:chemistry
chemical_list: D000911:Antibodies, Monoclonal; D011506:Proteins
keywords: Biopharmaceutical; Chromatography; Mass spectrometry; Monoclonal antibody; Therapeutic protein