Differentiation and verification of monoclonal antibody therapeutics by integrating accurate mass analyses at intact, subunit and subdomain levels for forensic investigation

Drugs@FDA: FDA-Approved Drugs, https://www.fda.gov. Kaplon, 2022, Antibodies to watch in 2022, MAbs, 14, 2014296, 10.1080/19420862.2021.2014296 Beck, 2011, Biosimilar, biobetter and next generation therapeutic antibodies, MAbs, 3, 107, 10.4161/mabs.3.2.14785 Ecker, 2015, The therapeutic monoclonal antibody market, MAbs, 7, 9, 10.4161/19420862.2015.989042 McSherry, 2016, Cysteinylation of a monoclonal antibody leads to its inactivation, MAbs, 8, 718, 10.1080/19420862.2016.1160179 Yan, 2016, Isomerization and oxidation in the complementarity-determining regions of a monoclonal antibody: a study of the modification-structure-function correlations by hydrogen-deuterium exchange mass spectrometry, Anal Chem, 88, 2041, 10.1021/acs.analchem.5b02800 Liu, 2015, Antibody glycosylation and its impact on the pharmacokinetics and pharmacodynamics of monoclonal antibodies and Fc-fusion proteins, J Pharm Sci, 104, 1866, 10.1002/jps.24444 Zhang, 2016, Glycan analysis of therapeutic glycoproteins, MAbs, 8, 205, 10.1080/19420862.2015.1117719 Wang, 2011, Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies, Mol Immunol, 48, 860, 10.1016/j.molimm.2010.12.009 Zhang, 2016, Characterization of the co-elution of host cell proteins with monoclonal antibodies during protein A purification, Biotechnol Prog, 32, 708, 10.1002/btpr.2272 Mo, 2012, Structural mass spectrometry in biologics discovery: advances and future trends, Drug Discov Today, 17, 1323, 10.1016/j.drudis.2012.07.006 Wei, 2013, High-resolution MS for structural characterization of protein therapeutics: advances and future directions, Bioanalysis, 5, 1299, 10.4155/bio.13.80 Rogers, 2015, Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics, MAbs, 7, 881, 10.1080/19420862.2015.1069454 Legrand, 2022, Structural identification and absolute quantification of monoclonal antibodies in suspected counterfeits using capillary electrophoresis and liquid chromatography-tandem mass spectrometry, Anal Bioanal Chem, 414, 2699, 10.1007/s00216-022-03913-y Lanzarotta, 2022, Analytical tools for combating suspect counterfeit drug products Xie, 2010, Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies, MAbs, 2, 379, 10.4161/mabs.11986 Yan, 2007, Analysis of post-translational modifications in recombinant monoclonal antibody IgG1 by reversed-phase liquid chromatography/mass spectrometry, J Chromatogr A, 1164, 153, 10.1016/j.chroma.2007.06.063 Bulau, 2016 Z. Hao, Zhang, Y., Horn, D., Sharma, S., Wu, S.L., Lin, I.A.N., Pan, Y.H., Yang, Y.F., Huhmer, A.F.R., A complete workflow solution for intact monoclonal antibody characterization using a new high-performance benchtop quadrupole-orbitrap LC-MS/MS, Application Note, Thermo Scientific. Samonig, 2013 Chevreux, 2011, Fast analysis of recombinant monoclonal antibodies using IdeS proteolytic digestion and electrospray mass spectrometry, Anal. Biochem., 415, 212, 10.1016/j.ab.2011.04.030 Janin-Bussat, 2013, Cetuximab Fab and Fc N-glycan fast characterization using IdeS digestion and liquid chromatography coupled to electrospray ionization mass spectrometry, Methods Mol. Biol., 988, 93, 10.1007/978-1-62703-327-5_7 An, 2014, A new tool for monoclonal antibody analysis: application of IdeS proteolysis in IgG domain-specific characterization, MAbs, 6, 879, 10.4161/mabs.28762 Ayoub, 2013, Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques, MAbs, 5, 699, 10.4161/mabs.25423 Wagner-Rousset, 2014, Antibody-drug conjugate model fast characterization by LC-MS following IdeS proteolytic digestion, MAbs, 6, 273, 10.4161/mabs.26773 Wagner-Rousset, 2021, Fast afucosylation profiling of glycoengineered antibody subunits by middle-up mass spectrometry, Methods Mol. Biol., 2271, 73, 10.1007/978-1-0716-1241-5_5 Srzentic, 2020, Interlaboratory study for characterizing monoclonal antibodies by top-down and middle-down mass spectrometry, J. Am. Soc. Mass Spectrom., 31, 1783, 10.1021/jasms.0c00036 Haverick, 2014, Separation of mAbs molecular variants by analytical hydrophobic interaction chromatography HPLC: overview and applications, MAbs, 6, 852, 10.4161/mabs.28693 DrugBank Online, https://go.drugbank.com/drugs/DB00073. Jung, 2014, Physicochemical characterization of Remsima, MAbs, 6, 1163, 10.4161/mabs.32221