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Biosimilarity under stress: A forced degradation study of Remicade® and Remsima™

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Pages 1197-1209 | Received 01 Feb 2017, Accepted 23 Jun 2017, Published online: 17 Aug 2017

References

  • Konara CS, Barnard RT, Hine D, Siegel E, Ferro V. The tortoise and the hare: Evolving regulatory landscapes for biosimilars. Trends Biotechnol 2016; 34(1):70-83; PMID:26620970; https://doi.org/10.1016/j.tibtech.2015.10.009
  • European Medicines Agency. Assessment report: Inflectra; 2013.
  • U.S. Food & Drug Administration. FDA Approves Inflectra, A Biosimilar To Remicade; 2016 Apr 05. [accessed 2016 Apr 16]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
  • Janssen Pharmaceutical. Remicade ® [package insert]; 2015.
  • Jung SK, Lee KH, Jeon JW, Lee JW, Kwon BO, Kim YJ, Bae JS, Kim D, Lee SY, Chang SJ. Physicochemical characterization of remsima®. mAbs 2014; 6(5):1163-77; PMID:25517302; https://doi.org/10.4161/mabs.32221
  • Celltrion, Inc. FDA Arthritis Advisory Committee. FDA Briefing Document: Arthritis Advisory Committee Meeting BLA 125544: CT-P13 a proposed biosimilar to remicade (infliximab); 2016. U.S. FDA.
  • Pisupati K, Tian Y, Okbazghi S, Benet A, Ackermann R, Ford M, Saveliev S, Hosfield CM, Urh M, Carson E, et al. A multidimensional analytical comparison of Remicade and the biosimilar Remsima. Anal Chem 2017; 89(9):4838-46; PMID:28365979; https://doi.org/10.1021/acs.analchem.6b04436
  • Celltrion, Inc. CT-P13 (inflximab biosimilar): Briefing Document for the Arthritis Advisory Committee; 2016. U.S. FDA.
  • Hawe A, Wiggenhorn M, van de Weert M, Garbe JH, Mahler H, Jiskoot W. Forced degradation of therapeutic proteins. J Pharm Sci 2012; 101(3):895-913; PMID:22083792; https://doi.org/10.1002/jps.22812
  • Luo Q, Joubert MK, Stevenson R, Ketchem RR, Narhi LO, Wypych J. Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem 2011; 286(28):25134-44; PMID:21518762; https://doi.org/10.1074/jbc.M110.160440
  • Chan CP. Forced degradation studies: Current trends and future perspectives for protein-based therapeutics. Expert Rev Proteomics 2016; 13(7):651-8; PMID:27285431; https://doi.org/10.1080/14789450.2016.1200469
  • Celltrion, Inc. Remsima™ [package insert]; 2014.
  • Lakowicz JR. Principles of fluorescence spectroscopy. New York City, NY: Springer Science & Business Media; 2013.
  • Ohadi K, Legge RL, Budman HM. Intrinsic fluorescence-based at situ soft sensor for monitoring monoclonal antibody aggregation. Biotechnol Prog 2015; 31(5):1423-32; PMID:26137937; https://doi.org/10.1002/btpr.2140
  • Garidel P, Hegyi M, Bassarab S, Weichel M. A rapid, sensitive and economical assessment of monoclonal antibody conformational stability by intrinsic tryptophan fluorescence spectroscopy. Biotechnol J 2008; 3(9–10):1201-11; PMID:18702089; https://doi.org/10.1002/biot.200800091
  • Filipe V, Jiskoot W, Basmeleh AH, Halim A, Schellekens H, Brinks V. Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice. mAbs 2012; 4(6):740-52; PMID:22951518; https://doi.org/10.4161/mabs.22066
  • Cathou RE, Kulczycki A, Haber E. Structural features of -immunoglobulin, antibody, and their fragments. circular dichroism studies. Biochemistry 1968; 7(11):3958-64; PMID:5722265; https://doi.org/10.1021/bi00851a024
  • Joshi V, Shivach T, Yadav N, Rathore AS. Circular dichroism spectroscopy as a tool for monitoring aggregation in monoclonal antibody therapeutics. Anal Chem 2014; 86(23):11606-13; PMID:25350583; https://doi.org/10.1021/ac503140j
  • Houde DJ, Berkowitz SA. Biophysical characterization of proteins in developing biopharmaceuticals. Boston MA: Elsevier; 2014.
  • Luo Q, Joubert MK, Stevenson R, Ketchem RR, Narhi LO, Wypych J. Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem 2011; 286(28):25134-44; PMID:21518762; https://doi.org/10.1074/jbc.M110.160440
  • Bertolotti-Ciarlet A, Wang W, Lownes R, Pristatsky P, Fang Y, McKelvey T, Li Y, Li Y, Drummond J, Prueksaritanont T. Impact of methionine oxidation on the binding of human IgG1 to FcRn and fcγ receptors. Mol Immunol 2009; 46(8):1878-82; PMID:19269032; https://doi.org/10.1016/j.molimm.2009.02.002
  • Liu D, Ren D, Huang H, Dankberg J, Rosenfeld R, Cocco MJ, Li L, Brems DN, Remmele Jr RL. Structure and stability changes of human IgG1 fc as a consequence of methionine oxidation. Biochemistry 2008; 47(18):5088-100; PMID:18407665; https://doi.org/10.1021/bi702238b
  • Houde D, Peng Y, Berkowitz SA, Engen JR. Post-translational modifications differentially affect IgG1 conformation and receptor binding. Mol Cell Proteomics 2010; 9(8):1716-28; PMID:20103567; https://doi.org/10.1074/mcp.M900540-MCP200
  • Khawli LA, Goswami S, Hutchinson R, Kwong ZW, Yang J, Wang X, Yao Z, Sreedhara A, Cano T, Tesar D, et al. Charge variants in IgG1: Isolation, characterization, in vitro binding properties and pharmacokinetics in rats. mAbs 2010; 2(6):613-24; PMID:20818176; https://doi.org/10.4161/mabs.2.6.13333
  • Wang W, Vlasak J, Li Y, Pristatsky P, Fang Y, Pittman T, Roman J, Wang Y, Prueksaritanont T, Ionescu R. Impact of methionine oxidation in human IgG1 fc on serum half-life of monoclonal antibodies. Mol Immunol 2011; 48(6):860-6; PMID:21256596; https://doi.org/10.1016/j.molimm.2010.12.009
  • Zhu J. Mammalian cell protein expression for biopharmaceutical production. Biotechnol Adv 2012; 30(5):1158-70; PMID:21968146; https://doi.org/10.1016/j.biotechadv.2011.08.022
  • Hmiel L, Brorson K, Boyne M, II. Post-translational structural modifications of immunoglobulin G and their effect on biological activity. Anal Bioanal Chem 2015; 407(1):79-94; PMID:25200070; https://doi.org/10.1007/s00216-014-8108-x
  • Sandoz. FDA Arthritis Advisory Committee. BLA 761042 GP2015: a proposed biosimilar to Enbrel (etanercept); 2016. U.S. FDA.
  • Sandoz. Oncologic Drugs Advisory Committee: ZARXIO (filgrastim); 2015. U.S. FDA.
  • Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G. Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci 2010; 99(5):2200-08; PMID:19918982; https://doi.org/10.1002/jps.21989
  • Health Canada. Remsima: Summary basis of decision; 2014.
  • Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, Zou G, Xu Z, Shankar G, Sealey DC. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014; 42(4):177-83; PMID:24962198; https://doi.org/10.1016/j.biologicals.2014.05.005
  • Ahmadi M, Bryson CJ, Cloake EA, Welch K, Filipe V, Romeijn S, Hawe A, Jiskoot W, Baker MP, Fogg MH. Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics. Pharm Res 2015; 32(4); PMID:25319104; https://doi.org/10.1007/s11095-014-1541-x
  • Paul R, Graff-Meyer A, Stahlberg H, Lauer ME, Rufer AC, Beck H, Briguet A, Schnaible V, Buckel T, Boeckle S. Structure and function of purified monoclonal antibody dimers induced by different stress conditions. Pharm Res 2012; 29(8):2047-59; PMID:22477068; https://doi.org/10.1007/s11095-012-0732-6
  • Bi V, Jawa V, Joubert MK, Kaliyaperumal A, Eakin C, Richmond K, Pan O, Sun J, Hokom M, Goletz TJ, et al. Development of a human antibody tolerant mouse model to assess the immunogenicity risk due to aggregated biotherapeutics. J Pharm Sci 2013; 102(10):3545-55; PMID:23925953; https://doi.org/10.1002/jps.23663
  • Rombach-Riegraf V, Karle AC, Wolf B, Sordé L, Koepke S, Gottlieb S, Krieg J, Djidja M, Baban A, Spindeldreher S, et al. Aggregation of human recombinant monoclonal antibodies influences the capacity of dendritic cells to stimulate adaptive T-cell responses in vitro. PLoS ONE 2013; 9(1):e86322; PMID:24466023; https://doi.org/10.1371/journal.pone.0086322
  • Greenspan L. Humidity fixed points of binary saturated aqueous solutions. Journal of Research of the National Bureau of Standards 1977; 81A(1):89; https://doi.org/10.6028/jres.081A.011
  • Bern M, Kil YJ, Becker C. Byonic: Advanced peptide and protein identification software. Curr Protoc Bioinformatics 2012; Dec;Chapter 13:Unit 13.20; PMID:23255153; https://doi.org/10.1002/0471250953.bi1320s40
  • Bern M, Cai Y, Goldberg D. Lookup peaks: A hybrid of de novo sequencing and database search for protein identification by tandem mass spectrometry. Anal Chem 2007; 79(4):1393-1400; PMID:17243770; https://doi.org/10.1021/ac0617013
  • Zhong Y, Hyung S, Ruotolo BT. Characterizing the resolution and accuracy of a second-generation traveling-wave ion mobility separator for biomolecular ions. Analyst 2011; 136(17):3534-41; PMID:21445388; https://doi.org/10.1039/c0an00987c
  • Giles K, Williams JP, Campuzano I. Enhancements in travelling wave ion mobility resolution. Rapid Commun Mass Spectrom 2011; 25(11):1559-66; PMID:21594930; https://doi.org/10.1002/rcm.5013
  • Tito MA, Tars K, Valegard K, Hajdu J, Robinson CV. Electrospray time-of-flight mass spectrometry of the intact MS2 virus capsid. J Am Chem Soc 2000; 122(14):3550-51; https://doi.org/10.1021/ja993740k
  • McKay AR, Ruotolo BT, Ilag LL, Robinson CV. Mass measurements of increased accuracy resolve heterogeneous populations of intact ribosomes. J Am Chem Soc 2006; 128(35):11433-42; PMID:16939266; https://doi.org/10.1021/ja061468q
  • Okbazghi SZ, More AS, White DR, Duan S, Shah IS, Joshi SB, Middaugh CR, Volkin DB, Tolbert TJ. Production, characterization, and biological evaluation of well-defined IgG1 fc glycoforms as a model system for biosimilarity analysis. J Pharm Sci 2016; 105(2):559-74; PMID:26869419; https://doi.org/10.1016/j.xphs.2015.11.003
  • Alsenaidy MA, Okbazghi SZ, Kim JH, Joshi SB, Middaugh CR, Tolbert TJ, Volkin DB. Physical stability comparisons of IgG1-Fc variants: Effects of N-Glycosylation site occupancy and asp/gln residues at site asn 297. J Pharm Sci 2014; 103(6):1613-27; PMID:24740840; https://doi.org/10.1002/jps.23975

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