Advances in native high-performance liquid chromatography and intact mass spectrometry for the characterization of biopharmaceutical products.
The characterization of biotherapeutics represents a major analytical challenge. This review discusses the current state-of-the-art in analytical technologies to profile biopharma products under native conditions, i.e., the protein three dimensional conformation is maintained during liquid chromatographic analysis. Native liquid-chromatographic modes that are discussed include aqueous size-exclusion chromatography, hydrophobic interaction chromatography, and ion-exchange chromatography. Infusion conditions and the possibilities and limitations to hyphenate native liquid chromatography to mass spectrometry are discussed. Furthermore, the applicability of native liquid-chromatography methods and intact mass spectrometry analysis for the characterization of monoclonal antibodies and antibody-drug conjugates is discussed.
['Tassi|Marco|M|', 'De Vos|Jelle|J|', 'Chatterjee|Sneha|S|', 'Sobott|Frank|F|', 'Bones|Jonathan|J|', 'Eeltink|Sebastiaan|S|http://orcid.org/0000-0002-5465-0127']
D000818:Animals D000911:Antibodies, Monoclonal D001688:Biological Products D002623:Chemistry Techniques, Analytical D002851:Chromatography, High Pressure Liquid D002853:Chromatography, Liquid D006801:Humans D006863:Hydrogen-Ion Concentration D013058:Mass Spectrometry D011489:Protein Denaturation D017510:Protein Folding D011506:Proteins D033081:Shear Strength D021241:Spectrometry, Mass, Electrospray Ionization D013314:Stress, Mechanical
bioprocessing native chromatography methods native mass spectrometry protein therapeutics