Charge variant native mass spectrometry benefits mass precision and dynamic range of monoclonal antibody intact mass analysis

References

• Yin Y, Han G, Zhou J, Dillon M, McCarty L, Gavino L, Ellerman D, Spiess C, Sandoval W, Carter PJ. Precise quantification of mixtures of bispecific IgG produced in single host cells by liquid chromatography-Orbitrap high-resolution mass spectrometry. MAbs. 2016;8(8):1467–1476. doi:10.1080/19420862.2016.1232217.
   PubMed Web of Science ®Google Scholar
• Marcoux J, Champion T, Colas O, Wagner-Rousset E, Corvaia N, Van Dorsselaer A, Beck A, Cianferani S. Native mass spectrometry and ion mobility characterization of trastuzumab emtansine, a lysine-linked antibody drug conjugate. Protein Sci. 2015;24(8):1210–1223. doi:10.1002/pro.2666.
   PubMed Web of Science ®Google Scholar
• Katta V, Chait BT. Observation of the heme-globin complex in native myoglobin by electrospray-ionization. J Am Chem Soc. 1991;113(22):8534–8535. doi:10.1021/ja00022a058.
   Web of Science ®Google Scholar
• Leney AC, Heck AJ. Native mass spectrometry: what is in the name? J Am Soc Mass Spectrom. 2017;28(1):5–13. doi:10.1007/s13361-016-1545-3.
   PubMed Web of Science ®Google Scholar
• Rosati S, Yang Y, Barendregt A, Heck AJ. Detailed mass analysis of structural heterogeneity in monoclonal antibodies using native mass spectrometry. Nat Protoc. 2014;9(4):967–976. doi:10.1038/nprot.2014.057.
   PubMed Web of Science ®Google Scholar
• Schachner L, Han G, Dillon M, Zhou J, McCarty L, Ellerman D, Yin Y, Spiess C, Lill JR, Carter PJ, et al. Characterization of chain pairing variants of bispecific IgG expressed in a single host cell by high-resolution native and denaturing mass spectrometry. Anal Chem. 2016;88(24):12122–12127. doi:10.1021/acs.analchem.6b02866.
   PubMed Web of Science ®Google Scholar
• Zhang HM, Li C, Lei M, Lundin V, Lee HY, Ninonuevo M, Lin K, Han G, Sandoval W, Lei D, et al. Structural and functional characterization of a hole-hole homodimer variant in a “knob-into-hole” bispecific. Anal Chem. 2017;89(24):13494–13501. doi:10.1021/acs.analchem.7b03830.
   PubMed Web of Science ®Google Scholar
• Debaene F, Boeuf A, Wagner-Rousset E, Colas O, Ayoub D, Corvaia N, Van Dorsselaer A, Beck A, Cianferani S. Innovative native MS methodologies for antibody drug conjugate characterization: high resolution native MS and IM-MS for average DAR and DAR distribution assessment. Anal Chem. 2014;86(21):10674–10683. doi:10.1021/ac502593n.
   PubMed Web of Science ®Google Scholar
• Thompson NJ, Hendriks LJ, de Kruif J, Throsby M, Heck AJ. Complex mixtures of antibodies generated from a single production qualitatively and quantitatively evaluated by native Orbitrap mass spectrometry. MAbs. 2014;6(1):197–203. doi:10.4161/mabs.27126.
   PubMed Web of Science ®Google Scholar
• Thompson NJ, Rosati S, Heck AJ. Performing native mass spectrometry analysis on therapeutic antibodies. Methods. 2014;65(1):11–17. doi:10.1016/j.ymeth.2013.05.003.
   PubMed Web of Science ®Google Scholar
• Rosati S, Rose RJ, Thompson NJ, van Duijn E, Damoc E, Denisov E, Makarov A, Heck AJ. Exploring an orbitrap analyzer for the characterization of intact antibodies by native mass spectrometry. Angew Chem Int Ed Engl. 2012;51(52):12992–12996. doi:10.1002/anie.201206745.
   PubMed Web of Science ®Google Scholar
• Rose RJ, Damoc E, Denisov E, Makarov A, Heck AJ. High-sensitivity Orbitrap mass analysis of intact macromolecular assemblies. Nat Methods. 2012;9(11):1084–1086. doi:10.1038/nmeth.2208.
   PubMed Web of Science ®Google Scholar
• Makarov A. Electrostatic axially harmonic orbital trapping: a high-performance technique of mass analysis. Anal Chem. 2000;72(6):1156–1162.
   PubMed Web of Science ®Google Scholar
• Makarov A, Denisov E. Dynamics of ions of intact proteins in the Orbitrap mass analyzer. J Am Soc Mass Spectrom. 2009;20(8):1486–1495. doi:10.1016/j.jasms.2009.03.024.
   PubMed Web of Science ®Google Scholar
• Lossl P, Snijder J, Heck AJ. Boundaries of mass resolution in native mass spectrometry. J Am Soc Mass Spectrom. 2014;25(6):906–917. doi:10.1007/s13361-014-0874-3.
   PubMed Web of Science ®Google Scholar
• Muneeruddin K, Nazzaro M, Kaltashov IA. Characterization of intact protein conjugates and biopharmaceuticals using ion-exchange chromatography with online detection by native electrospray ionization mass spectrometry and top-down tandem mass. Anal Chem. 2015;87(19):10138–10145. doi:10.1021/acs.analchem.5b02982.
   PubMed Web of Science ®Google Scholar
• Muneeruddin K, Thomas JJ, Salinas PA, Kaltashov IA. Characterization of small protein aggregates and oligomers using size exclusion chromatography with online detection by native electrospray ionization mass spectrometry. Anal Chem. 2014;86(21):10692–10699. doi:10.1021/ac502590h.
   PubMed Web of Science ®Google Scholar
• Chen B, Peng Y, Valeja SG, Xiu L, Alpert AJ, Ge Y. Online hydrophobic interaction chromatography-mass spectrometry for top-down proteomics. Anal Chem. 2016;88(3):1885–1891. doi:10.1021/acs.analchem.5b04285.
   PubMed Web of Science ®Google Scholar
• Belov AM, Viner R, Santos MR, Horn DM, Bern M, Karger BL, Ivanov AR. Analysis of proteins, protein complexes, and organellar proteomes using sheathless capillary zone electrophoresis - native mass spectrometry. J Am Soc Mass Spectrom. 2017;28(12):2614–2634. doi:10.1007/s13361-017-1781-1.
   PubMed Web of Science ®Google Scholar
• Patel K, Borchardt RT. Chemical pathways of peptide degradation II Kinetics of deamidation of an asparaginyl residue in a model hexapeptide. Pharm Res. 1990;7(7):703–711.
   PubMed Web of Science ®Google Scholar
• Muneeruddin K, Bobst CE, Frenkel R, Houde D, Turyan I, Sosic Z, Kaltashov IA. Characterization of a PEGylated protein therapeutic by ion exchange chromatography with on-line detection by native ESI MS and MS/MS. Analyst. 2017;142(2):336–344. doi:10.1039/c6an02041k.
   PubMed Web of Science ®Google Scholar
• Vlasak J, Ionescu R. Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods. Curr Pharm Biotechnol. 2008;9(6):468–481.
   PubMed Web of Science ®Google Scholar
• Harris RJ, Kabakoff B, Macchi FD, Shen FJ, Kwong M, Andya JD, Shire SJ, Bjork N, Totpal K, Chen AB. Identification of multiple sources of charge heterogeneity in a recombinant antibody. J Chromatogr B Biomed Sci Appl. 2001;752(2):233–245.
   PubMedGoogle Scholar
• Weitzhandler M, Farnan D, Horvath J, Rohrer JS, Slingsby RW, Avdalovic N, Pohl C. Protein variant separations by cation-exchange chromatography on tentacle-type polymeric stationary phases. J Chromatogr A. 1998;828(1–2):365–372.
   PubMed Web of Science ®Google Scholar
• Zhang L, Patapoff T, Farnan D, Zhang B. Improving pH gradient cation-exchange chromatography of monoclonal antibodies by controlling ionic strength. J Chromatogr A. 2013;1272:.56–64. doi:10.1016/j.chroma.2012.11.060.
   PubMed Web of Science ®Google Scholar
• Farnan D, Moreno GT. Multiproduct high-resolution monoclonal antibody charge variant separations by pH gradient ion-exchange chromatography. Anal Chem. 2009;81(21):8846–8857. doi:10.1021/ac901408j.
   PubMed Web of Science ®Google Scholar
• Fussl F, Cook K, Scheffler K, Farrell A, Mittermayr S, Bones J. Charge variant analysis of monoclonal antibodies using direct coupled pH gradient cation exchange chromatography to high-resolution native mass spectrometry. Anal Chem. 2018;90(7):4669–4676. doi:10.1021/acs.analchem.7b05241.
   PubMed Web of Science ®Google Scholar
• Konermann L. Addressing a common misconception: ammonium acetate as neutral pH “Buffer” for native electrospray mass spectrometry. J Am Soc Mass Spectrom. 2017;28(9):1827–1835. doi:10.1007/s13361-017-1739-3.
   PubMed Web of Science ®Google Scholar
• Du Y, Walsh A, Ehrick R, Xu W, May K, Liu H. Chromatographic analysis of the acidic and basic species of recombinant monoclonal antibodies. MAbs. 2012;4(5):578–585. doi:10.4161/mabs.21328.
   PubMed Web of Science ®Google Scholar
• Gazis PR, Horn DM The Sliding Window Algorithm for the Analysis of LC/MS Intact Protein Data Proceedings of the 63rd ASMS Conference on Mass Spectrometry and Allied Topics; 2015; St Louis, MO, USA.
   Google Scholar
• Lazar AC, Wang L, Blattler WA, Amphlett G, Lambert JM, Zhang W. Analysis of the composition of immunoconjugates using size-exclusion chromatography coupled to mass spectrometry. Rapid Commun Mass Spectrom. 2005;19(13):1806–1814. doi:10.1002/rcm.1987.
   PubMed Web of Science ®Google Scholar