Advanced assessment of the physicochemical characteristics of Remicade® and Inflectra® by sensitive LC/MS techniques

References

• Reichert JM. Antibodies to watch in 2016. MAbs 2016; 8:197-204; PMID:26651519; http://dx.doi.org/10.1080/19420862.2015.1125583
   PubMed Web of Science ®Google Scholar
• Beck A, Wagner-Rousset E, Ayoub D, Van Dorsselaer A, Sanglier-Cianferani S. Characterization of therapeutic antibodies and related products. Anal Chem 2013; 85:715-36; PMID:23134362; http://dx.doi.org/10.1021/ac3032355
   PubMed Web of Science ®Google Scholar
• Beck A. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 2011; 3:107-10; PMID:21285536; http://dx.doi.org/10.4161/mabs.3.2.14785
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. 2015; http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
   Google Scholar
• Beck A, Debaene F, Diemer H, Wagner-Rousset E, Colas O, Van Dorsselaer A, Cianferani S. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom 2015; 50:285-97; PMID:25800010; http://dx.doi.org/10.1002/jms.3554
   PubMed Web of Science ®Google Scholar
• Beck A, Reichert JM. Marketing approval of Mogamulizumab: A triumph for glyco-engineering. MAbs 2012; 4:419-25; PMID:22699226; http://dx.doi.org/10.4161/mabs.20996
   PubMed Web of Science ®Google Scholar
• Liu H, Ponniah G, Zhang HM, Nowak C, Neill A, Gonzalez-Lopez N, Patel R, Cheng G, Kita AZ, Andrien B. In vitro and in vivo modifications of recombinant and human IgG antibodies. MAbs 2014; 6:1145-54; PMID:25517300; http://dx.doi.org/10.4161/mabs.29883
   PubMed Web of Science ®Google Scholar
• Internation Conference on Harmonisation. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B. 1999; http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
   Google Scholar
• Beck A, Sanglier-Cianferani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 2012; 84:4637-46; PMID:22510259; http://dx.doi.org/10.1021/ac3002885
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation. Guidance on specifications: Test procedures and acceptance criteria for biotechnological/biological products. 1999; http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
   Google Scholar
• International Conference on Harmonisation. Guidance on Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process. 2005; http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
   Google Scholar
• Beck A, Diemer H, Ayoub D, Debaene F, Wagner-Rousset E, Carapito D, Van Dorsselaer A, Sanglier-Cianférani S. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Anal Chem 2013; 48:14; http://dx.doi.org/10.1016/j.trac.2013.02.014
   Web of Science ®Google Scholar
• Xie H, Chakraborty A, Ahn J, Yu YQ, Dakshinamoorthy DP, Gilar M, Chen W, Skilton SJ, Mazzeo JR. Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies. MAbs 2010; 2:379-94; PMID:20458189; http://dx.doi.org/10.4161/mabs.11986
   PubMed Web of Science ®Google Scholar
• Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry. MAbs 2013; 5:621-3; PMID:23924791; http://dx.doi.org/10.4161/mabs.25864
   PubMed Web of Science ®Google Scholar
• Schellekens H, Lietzan E, Faccin F, Venema J. Biosimilar monoclonal antibodies: The scientific basis for extrapolation. Expert Opin Biol Ther 2015; 15:1633-46; PMID:26365396; http://dx.doi.org/10.1517/14712598.2015.1083552
   PubMed Web of Science ®Google Scholar
• Jung SK, Lee KH, Jeon JW, Lee JW, Kwon BO, Kim YJ, Bae JS, Kim DI, Lee SY, Chang SJ. Physicochemical characterization of Remsima. MAbs 2014; 6:1163-77; PMID:25517302; http://dx.doi.org/10.4161/mabs.32221
   PubMed Web of Science ®Google Scholar
• Lauber MA, Yu YQ, Brousmiche DW, Hua Z, Koza SM, Magnelli P, Guthrie E, Taron CH, Fountain KJ. Rapid preparation of released N-glycans for HILIC analysis using a labeling reagent that facilitates sensitive fluorescence and ESI-MS detection. Anal Chem 2015; 87:5401-9; PMID:25927596; http://dx.doi.org/10.1021/acs.analchem.5b00758
   PubMed Web of Science ®Google Scholar
• Satoh M, Iida S, Shitara K. Non-fucosylated therapeutic antibodies as next-generation therapeutic antibodies. Expert Opin Biol Ther 2006; 6:1161-73; PMID:17049014; http://dx.doi.org/10.1517/14712598.6.11.1161
   PubMed Web of Science ®Google Scholar
• Houde D, Berkowitz SA, Engen JR. The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies. J Pharm Sci 2011; 100:2071-86; PMID:21491437; http://dx.doi.org/10.1002/jps.22432
   PubMed Web of Science ®Google Scholar
• Tsuchida D, Yamazaki K, Akashi S. Comprehensive characterization of relationship between higher-order structure and FcRn Binding affinity of stress-exposed monoclonal antibodies. Pharm Res 2016; 33:994-1002; PMID:26694753; http://dx.doi.org/10.1007/s11095-015-1845-5
   PubMed Web of Science ®Google Scholar
• Houde D, Arndt J, Domeier W, Berkowitz S, Engen JR. Characterization of IgG1 conformation and conformational dynamics by hydrogen/deuterium exchange mass spectrometry. Anal Chem 2009; 81:2644-51; PMID:19265386; http://dx.doi.org/10.1021/ac802575y
   PubMed Web of Science ®Google Scholar
• Fang J, Richardson J, Du Z, Zhang Z. Effect of Fc-glycan structure on the conformational stability of IgG revealed by hydrogen/deuterium exchange and limited proteolysis. Biochemistry 2016; 55:860-8; PMID:26812426; http://dx.doi.org/10.1021/acs.biochem.5b01323
   PubMed Web of Science ®Google Scholar
• Khor HK, Jacoby ME, Squier TC, Chu GC, Chelius D. Identification of methionine sulfoxide diastereomers in immunoglobulin gamma antibodies using methionine sulfoxide reductase enzymes. MAbs 2010; 2:299-308; PMID:20404551; http://dx.doi.org/10.4161/mabs.2.3.11755
   PubMed Web of Science ®Google Scholar
• Silva JC, Gorenstein MV, Li GZ, Vissers JP, Geromanos SJ. Absolute quantification of proteins by LCMSE: A virtue of parallel MS acquisition. Mol Cell Proteomics 2006; 5:144-56; PMID:16219938; http://dx.doi.org/10.1074/mcp.M500230-MCP200
   PubMed Web of Science ®Google Scholar
• Chernajovsky Y, Nissim A (Eds.). Therapeutic Antibodies. Berlin Heidelberg: Springer-Verlag Berlin Heidelberg; 2008
   Google Scholar
• Igawa T, Tsunoda H, Kuramochi T, Sampei Z, Ishii S, Hattori K. Engineering the variable region of therapeutic IgG antibodies. MAbs 2011; 3:243-252; PMID:21406966; http://dx.doi.org/10.4161/mabs.3.3.15234
   PubMed Web of Science ®Google Scholar
• Fang J, Nevin P, Kairys V, Venclovas C, Engen JR, Beuning PJ. Conformational analysis of processivity clamps in solution demonstrates that tertiary structure does not correlate with protein dynamics. Structure 2014; 22:572-81; PMID:24613485; http://dx.doi.org/10.1016/j.str.2014.02.001
   PubMed Web of Science ®Google Scholar
• Wang X, Das TK, Singh SK, Kumar S. Potential aggregation prone regions in biotherapeutics: A survey of commercial monoclonal antibodies. MAbs 2009; 1:254-67; PMID:20065649; http://dx.doi.org/10.4161/mabs.1.3.8035
   PubMed Web of Science ®Google Scholar
• Doneanu CE, Anderson M, Williams BJ, Lauber MA, Chakraborty A, Chen W. Enhanced detection of low-abundance host cell protein impurities in high-purity monoclonal antibodies down to 1 ppm using ion mobility mass spectrometry coupled with multidimensional liquid chromatography. Anal Chem 2015; 87:10283-91; PMID:26266576; http://dx.doi.org/10.1021/acs.analchem.5b02103
   PubMed Web of Science ®Google Scholar
• Distler U, Kuharev J, Navarro P, Levin Y, Schild H, Tenzer S. Drift time-specific collision energies enable deep-coverage data-independent acquisition proteomics. Nat Methods 2014; 11:167-70; PMID:24336358; http://dx.doi.org/10.1038/nmeth.2767
   PubMed Web of Science ®Google Scholar
• Distler U, Kuharev J, Navarro P, Tenzer S. Label-free quantification in ion mobility-enhanced data-independent acquisition proteomics. Nat Protoc 2016; 11:795-812; PMID:27010757; http://dx.doi.org/10.1038/nprot.2016.042
   PubMed Web of Science ®Google Scholar
• Silva JC, Denny R, Dorschel C, Gorenstein MV, Li GZ, Richardson K, Wall D, Geromanos SJ. Simultaneous qualitative and quantitative analysis of the Escherichia coli proteome: A sweet tale. Mol Cell Proteomics 2006; 5:589-607; PMID:16399765; http://dx.doi.org/10.1074/mcp.M500321-MCP200
   PubMed Web of Science ®Google Scholar
• Ahn J, Jung MC, Wyndham K, Yu YQ, Engen JR. Pepsin immobilized on high-strength hybrid particles for continuous flow online digestion at 10,000 psi. Anal Chem 2012; 84:7256-62; PMID:22856522; http://dx.doi.org/10.1021/ac301749h
   PubMed Web of Science ®Google Scholar
• Wales TE, Engen JR. Hydrogen exchange mass spectrometry for the analysis of protein dynamics. Mass Spectrom Rev 2006; 25:158-70; PMID:16208684; http://dx.doi.org/10.1002/mas.20064
   PubMed Web of Science ®Google Scholar
• Fang J, Rand KD, Beuning PJ, Engen JR. False EX1 signatures caused by sample carryover during HX MS analyses. Int J Mass Spectrom 2011; 302:19-25; PMID:21643454; http://dx.doi.org/10.1016/j.ijms.2010.06.039
   PubMed Web of Science ®Google Scholar
• Geromanos SJ, Hughes C, Ciavarini S, Vissers JP, Langridge JI. Using ion purity scores for enhancing quantitative accuracy and precision in complex proteomics samples. Anal Bioanal Chem 2012; 404:1127-39; PMID:22811061; http://dx.doi.org/10.1007/s00216-012-6197-y
   PubMed Web of Science ®Google Scholar