title: Intact protein analysis in the biopharmaceutical field.
abstract: In recent years, a growing number of biopharmaceutical proteins have been produced and are already available, or will be soon available, in the market. These molecules are more complex to analyze than conventional low molecular weight drugs, and thus need powerful analytical approaches for the entire development and delivery process. This review summarizes the analytical techniques available for intact protein determination and the main development steps in which they are applicable. A strong emphasis has been put on separation techniques, liquid chromatography and electrophoretic techniques, but mass spectrometry and spectroscopic approaches are also mentioned. Overall, we highlight how several analytical strategies are necessary to obtain global information.
authors.affiliation: School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Bd d'Yvoy 20, 1211 Geneva 4, Switzerland.
authors.forename: Aline
authors.initials: A
authors.lastname: Staub
authors.forename: Davy
authors.initials: D
authors.lastname: Guillarme
authors.forename: Julie
authors.initials: J
authors.lastname: Schappler
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Veuthey
authors.forename: Serge
authors.initials: S
authors.lastname: Rudaz
mesh_terms: D000327:Adsorption; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002846:Chromatography, Affinity / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002852:Chromatography, Ion Exchange / Q000379:methods; D002853:Chromatography, Liquid / Q000379:methods; D004586:Electrophoresis / Q000379:methods; D019075:Electrophoresis, Capillary / Q000379:methods; D007525:Isoelectric Focusing / Q000379:methods; D013058:Mass Spectrometry / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011499:Protein Processing, Post-Translational; D011506:Proteins / Q000032:analysis*; D012997:Solvents / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D011506:Proteins; D012997:Solvents