4,192
Views
97
CrossRef citations to date
0
Altmetric
Report

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

, , , , , & show all
Pages 810-816 | Received 22 Apr 2013, Accepted 31 May 2013, Published online: 06 Jun 2013

References

  • Baldrick P. Safety evaluation of biological drugs: what are toxicology studies in primates telling us?. Regul Toxicol Pharmacol 2011; 59:227 - 36; http://dx.doi.org/10.1016/j.yrtph.2010.10.005; PMID: 20937341
  • Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2005; 20:Suppl 6 vi3 - 9; http://dx.doi.org/10.1093/ndt/gfh1092; PMID: 15958824
  • Schellekens H.. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther. 2002; 24:1720 - 40 discussion 19
  • Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 2006; 21:Suppl 5 v9 - 12; http://dx.doi.org/10.1093/ndt/gfl476; PMID: 16959792
  • Wolbink GJ, Aarden LA, Dijkmans BA. Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol 2009; 21:211 - 5; http://dx.doi.org/10.1097/BOR.0b013e328329ed8b; PMID: 19399992
  • Koren E, De Groot AS, Jawa V, Beck KD, Boone T, Rivera D, et al. Clinical validation of the “in silico” prediction of immunogenicity of a human recombinant therapeutic protein. Clin Immunol 2007; 124:26 - 32; http://dx.doi.org/10.1016/j.clim.2007.03.544; PMID: 17490912
  • De Groot AS, Knopp PM, Martin W. De-immunization of therapeutic proteins by T-cell epitope modification. Dev Biol (Basel) 2005; 122:171 - 94; PMID: 16375261
  • Harding FA, Stickler MM, Razo J, DuBridge RB. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. MAbs 2010; 2:256 - 65; http://dx.doi.org/10.4161/mabs.2.3.11641; PMID: 20400861
  • Gaitonde P, Balu-Iyer SV. In vitro immunogenicity risk assessment of therapeutic proteins in preclinical setting. Methods Mol Biol 2011; 716:267 - 80; http://dx.doi.org/10.1007/978-1-61779-012-6_16; PMID: 21318912
  • Brennan FR, Morton LD, Spindeldreher S, Kiessling A, Allenspach R, Hey A, et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. MAbs 2010; 2:233 - 55; http://dx.doi.org/10.4161/mabs.2.3.11782; PMID: 20421713
  • Bugelski PJ, Treacy G. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr Opin Mol Ther 2004; 6:10 - 6; PMID: 15011776
  • Descotes J. Immunotoxicity of monoclonal antibodies. MAbs 2009; 1:104 - 11; http://dx.doi.org/10.4161/mabs.1.2.7909; PMID: 20061816
  • International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Preclinical safety evaluation of biotechnology derived pharmaceuticals S6(R1). (online) 2011.
  • Committee for medicinal products for human use. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. 2008.
  • Brinks V, Jiskoot W, Schellekens H. Immunogenicity of therapeutic proteins: the use of animal models. Pharm Res 2011; 28:2379 - 85; http://dx.doi.org/10.1007/s11095-011-0523-5; PMID: 21744171
  • Wierda D, Smith HW, Zwickl CM. Immunogenicity of biopharmaceuticals in laboratory animals. Toxicology 2001; 158:71 - 4; http://dx.doi.org/10.1016/S0300-483X(00)00410-8; PMID: 11164995
  • Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J, et al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul Toxicol Pharmacol 2009; 54:164 - 82; http://dx.doi.org/10.1016/j.yrtph.2009.03.012; PMID: 19345250
  • Swanson SJ, Bussiere J. Immunogenicity assessment in non-clinical studies. Curr Opin Microbiol 2012; 15:337 - 47; http://dx.doi.org/10.1016/j.mib.2012.05.015; PMID: 22770538
  • Gorovits B. Antidrug antibody assay validation: industry survey results. AAPS J 2009; 11:133 - 8; http://dx.doi.org/10.1208/s12248-009-9091-6; PMID: 19255857
  • Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011; 305:1460 - 8; http://dx.doi.org/10.1001/jama.2011.406; PMID: 21486979
  • de Vries MK, Wolbink GJ, Stapel SO, de Vrieze H, van Denderen JC, Dijkmans BA, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis 2007; 66:1252 - 4; http://dx.doi.org/10.1136/ard.2007.072397; PMID: 17472991
  • Isaacs JD, Manna VK, Rapson N, Bulpitt KJ, Hazleman BL, Matteson EL, et al. CAMPATH-1H in rheumatoid arthritis--an intravenous dose-ranging study. Br J Rheumatol 1996; 35:231 - 40; http://dx.doi.org/10.1093/rheumatology/35.3.231; PMID: 8620297
  • Schellekens H. The immunogenicity of therapeutic proteins. Discov Med 2010; 9:560 - 4; PMID: 20587346
  • Curtis BR, Swyers J, Divgi A, McFarland JG, Aster RH. Thrombocytopenia after second exposure to abciximab is caused by antibodies that recognize abciximab-coated platelets. Blood 2002; 99:2054 - 9; http://dx.doi.org/10.1182/blood.V99.6.2054; PMID: 11877279
  • Getts DR, Getts MT, McCarthy DP, Chastain EM, Miller SD. Have we overestimated the benefit of human(ized) antibodies?. MAbs 2010; 2:682 - 94; http://dx.doi.org/10.4161/mabs.2.6.13601; PMID: 20935511
  • Clark M. Antibody humanization: a case of the ‘Emperor’s new clothes’?. Immunol Today 2000; 21:397 - 402; http://dx.doi.org/10.1016/S0167-5699(00)01680-7; PMID: 10916143
  • Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 2011; 39:100 - 9; http://dx.doi.org/10.1016/j.biologicals.2011.01.006; PMID: 21353596
  • Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction. Curr Pharm Biotechnol 2002; 3:349 - 60; http://dx.doi.org/10.2174/1389201023378175; PMID: 12463417
  • Thullier P, Chahboun S, Pelat T. A comparison of human and macaque (Macaca mulatta) immunoglobulin germline V regions and its implications for antibody engineering. MAbs 2010; 2:528 - 38; http://dx.doi.org/10.4161/mabs.2.5.12545; PMID: 20562531
  • Shankar G, Pendley C, Stein KE. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol 2007; 25:555 - 61; http://dx.doi.org/10.1038/nbt1303; PMID: 17483842
  • Wadhwa M, Thorpe R. Strategies and assays for the assessment of unwanted immunogenicity. J Immunotoxicol 2006; 3:115 - 21; http://dx.doi.org/10.1080/15476910600845534; PMID: 18958691
  • Chapman K, Pullen N, Coney L, Dempster M, Andrews L, Bajramovic J, et al. Preclinical development of monoclonal antibodies: considerations for the use of non-human primates. MAbs 2009; 1:505 - 16; http://dx.doi.org/10.4161/mabs.1.5.9676; PMID: 20065651
  • Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005; 36:3 - 10; http://dx.doi.org/10.1016/j.ymeth.2005.01.001; PMID: 15848070

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.