Preclinical safety testing of monoclonal antibodies: the significance of species relevance
Abstract
Selecting a pharmacologically relevant animal species for testing the safety and toxicity of novel monoclonal antibody (mAb) therapies to support clinical testing can be challenging. Frequently, the species of choice is the primate. With the increased number of mAbs in the pharmaceutical pipeline, this has significant implications for primate use, and so raises several important scientific, ethical and economic issues. Here, following a recent international workshop held to debate this topic, we discuss issues in the preclinical testing of mAbs, with a particular focus on species relevance and primate use, and provide suggestions for how these issues might be addressed.
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The specific choice for FIH dose depends on several factors: species cross-reactivity, relevance of animal models, steepness of dose response, PK/PD relationship, nature of toxicity, and precedence of molecules in similar pathways.
“The specific choice for FIH dose depends on several factors: species cross‐reactivity, relevance of animal models, steepness of dose response, PK/PD relationship, nature of toxicity such as predictability, reversibility, tolerability, manageability, and the precedence of molecules in similar pathways.70”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [70]
Cites
Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412
Suntharalingam, G., Perry, M. R., Ward, S., Brett, S. J., Castello-Cortes, A., Brunner, M. D., & Panoskaltsis, N. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa063842 · Cited by 2,164 · cited 1× · see citing works
“However, as recently shown by the clinical effects observed for TGN1412, an anti-CD28 super-agonist mA”
BackgroundMonoclonal antibody successes in the clinic
Reichert, J. M., Rosensweig, C., Faden, L. B., & Dewitz, M. C. (2005) · Nature Biotechnology · doi:10.1038/nbt0905-1073 · Cited by 736 · see citing works
Loss of Siglec expression on T lymphocytes during human evolution
Nguyen, D. H., Hurtado-Ziola, N., Gagneux, P., & Varki, A. (2006) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.0510484103 · Cited by 204 · see citing works
Scientific and regulatory considerations on the immunogenicity of biologics
Shankar, G., Shores, E. W., Wagner, C. L., & Mire‐Sluis, A. R. (2006) · Trends in biotechnology · doi:10.1016/j.tibtech.2006.04.001 · Cited by 175 · see citing works
Reichert, J. M., & Pavlou, A. K. (2004) · Nature Reviews Drug Discovery · doi:10.1038/nrd1386 · Cited by 122 · see citing works
Mould, D. R., Davis, C. B., Minthorn, E. A., Kwok, D. C., Elliott, M. J., Luggen, M. E., & Totoritis, M. C. (1999) · Clinical Pharmacology & Therapeutics · doi:10.1016/s0009-9236(99)70032-9 · Cited by 83 · see citing works
Clarke, J. B., Leach, W., Pippig, S. D., Joshi, A., Wu, B. M., House, R. V., & Beyer, J. C. (2004) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2004.06.007 · Cited by 77 · see citing works
Bugelskil, P. J., Herzykl, D. J., Rehm, S., Harmsen, A. G., Gore, E., Williams, D. M., Maleeff, B. E., Badger, A. M., Truneh, A., O'Brien, S., et al. (2000) · Human & Experimental Toxicology · doi:10.1191/096032700678815783 · Cited by 75 · see citing works
Kon, O. M., Sihra, B. S., Loh, L., Barkans, J. R., Compton, C. H., Barnes, N., Larché, M., & Kay, A. B. (2001) · European Respiratory Journal · doi:10.1183/09031936.01.00064101 · Cited by 67 · see citing works
Anti-infective monoclonal antibodies: perils and promise of development
Reichert, J. M., & Dewitz, M. C. (2006) · Nature Reviews Drug Discovery · doi:10.1038/nrd1987 · Cited by 58 · see citing works
Herzyk, D. J., Gore, E. R., Polsky, R., Nadwodny, K. L., Maier, C. C., Liu, S., Hart, T. K., Harmsen, A. G., & Bugelski, P. J. (2001) · Infection and Immunity · doi:10.1128/iai.69.2.1032-1043.2001 · Cited by 47 · see citing works
Comparative Pharmacodynamics of Keliximab and Clenoliximab in Transgenic Mice Bearing Human CD4
Sharma, A., Davis, C. B., Tobia, L. A. P., Kwok, D. C., Tucci, M. G., Gore, E. R., Herzyk, D. J., & Hart, T. K. (2000) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/s0022-3565(24)39200-6 · Cited by 41 · see citing works
Yocum, D. E., Solinger, A. M., Tesser, J., Gluck, O. S., Cornett, M., O’Sullivan, F. X., Nordensson, K., Dallaire, B. K., Cd, S., & Lipani, J. A. (1998) · PubMed · Cited by 30 · see citing works
Wu, B. M., Joshi, A., Ren, S., & Ng, C. M. (2006) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.20475 · Cited by 28 · see citing works
Snodin, D. J., & Ryle, P. R. (2006) · BioDrugs · doi:10.2165/00063030-200620010-00003 · Cited by 26 · see citing works
Podolin, P. L., Webb, E. F., Reddy, M. P., Truneh, A., & Griswold, D. E. (2000) · Immunology · doi:10.1046/j.1365-2567.2000.00946.x · Cited by 21 · see citing works
Regulating biopharmaceuticals under CDER versus CBER: an insider's perspective
Schwieterman, W. D. (2006) · Drug Discovery Today · doi:10.1016/j.drudis.2006.08.011 · Cited by 20 · see citing works
Exploiting directed evolution for the discovery of biologicals.
Douthwaite, J. A., & Jermutus, L. (2006) · PubMed · Cited by 7 · see citing works
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Sorted by citations
The safety and side effects of monoclonal antibodies
Hansel, T. T., Kropshofer, H., Singer, T., Mitchell, J. A., & George, A. J. T. (2010) · Nature Reviews Drug Discovery · doi:10.1038/nrd3003 · Cited by 1,151 · see citing works
Impact of Product-Related Factors on Immunogenicity of Biotherapeutics
Singh, S. K. (2011) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.22276 · Cited by 350 · see citing works
Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development
Ovacik, M., & Lin, K. (2018) · Clinical and Translational Science · doi:10.1111/cts.12567 · Cited by 299 · see citing works
Pentšuk, N., & van der Laan, J. W. (2009) · Birth Defects Research Part B Developmental and Reproductive Toxicology · doi:10.1002/bdrb.20201 · Cited by 287 · see citing works
Developmental and reproductive toxicology studies in nonhuman primates
Chellman, G. J., Bussiere, J. L., Makori, N., Martin, P. L., Ooshima, Y., & Weinbauer, G. F. (2009) · Birth Defects Research Part B Developmental and Reproductive Toxicology · doi:10.1002/bdrb.20216 · Cited by 160 · see citing works
Burden, N., Chapman, K. L., Sewell, F. R., & Robinson, V. (2015) · PubMed Central · Cited by 156 · see citing works
Self-citationZheng, Y., Tesar, D. B., Benincosa, L., Birnböck, H., Boswell, C. A., Bumbaca, D., Cowan, K. J., Danilenko, D. M., Daugherty, A. L., Fielder, P. J., et al. (2012) · mAbs · doi:10.4161/mabs.4.2.19387 · Cited by 149 · see citing works
Immunotoxicity of monoclonal antibodies
Descotes, J. (2009) · mAbs · doi:10.4161/mabs.1.2.7909 · Cited by 140 · see citing works
Antibody Drug Conjugates: Nonclinical Safety Considerations
Hinrichs, M. J., & Dixit, R. (2015) · The AAPS Journal · doi:10.1208/s12248-015-9790-0 · Cited by 115 · see citing works
Capture, isolation and release of cancer cells with aptamer-functionalized glass bead array
Wan, Y., Liu, Y., Allen, P. B., Asghar, W., Mahmood, M. A. I., Tan, J., Duhon, H., Kim, Y. T., Ellington, A. D., & Iqbal, S. M. (2012) · Lab on a Chip · doi:10.1039/c2lc21251j · Cited by 111 · see citing works
Warncke, M., Calzascia, T., Coulot, M., Balke, N., Touil, R., Kolbinger, F., & Heusser, C. (2012) · The Journal of Immunology · doi:10.4049/jimmunol.1200090 · Cited by 102 · see citing works
Drug Development of Therapeutic Monoclonal Antibodies
Mould, D. R., & Meibohm, B. (2016) · BioDrugs · doi:10.1007/s40259-016-0181-6 · Cited by 101 · see citing works
Preclinical development of monoclonal antibodies
Chapman, K. L., Pullen, N., Coney, L., Dempster, M., Andrews, L., Bajramovic, J. J., Baldrick, P., Buckley, L. A., Jacobs, A., Hale, G., et al. (2009) · mAbs · doi:10.4161/mabs.1.5.9676 · Cited by 99 · see citing works
Self-citationOpportunities for the replacement of animals in the study of nausea and vomiting
Holmes, A., Rudd, J. A., Tattersall, F., Aziz, Q., & Andrews, P. (2009) · British Journal of Pharmacology · doi:10.1111/j.1476-5381.2009.00176.x · Cited by 86 · see citing works
Stewart, J. (2009) · Reproductive Toxicology · doi:10.1016/j.reprotox.2009.04.002 · Cited by 79 · see citing works
Jagessar, S. A., Kap, Y. S., Heijmans, N., van Driel, N., van Straalen, L., Bajramovic, J. J., Brok, H., Blezer, E. L. A., Bauer, J., Laman, J. D., et al. (2010) · Journal of Neuropathology & Experimental Neurology · doi:10.1097/nen.0b013e3181d5d053 · Cited by 77 · see citing works
Clinical immunotoxicity of therapeutic proteins
Descotes, J., & Gouraud, A. (2008) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425250802525496 · Cited by 76 · see citing works
Jarvis, P., Srivastav, S., Vogelwedde, E., Stewart, J., Mitchard, T. L., & Weinbauer, G. F. (2010) · Birth Defects Research Part B Developmental and Reproductive Toxicology · doi:10.1002/bdrb.20234 · Cited by 70 · see citing works
Chimpanzees in Biomedical and Behavioral Research
Institute of Medicine and National Research Council (2011) · National Academies Press eBooks · doi:10.17226/13257 · Cited by 128 · see citing works
Chapman, K. L., Andrews, L., Bajramovic, J. J., Baldrick, P., Black, L. E., Bowman, C., Buckley, L. A., Coney, L., Couch, J. A., Dempster, A. M., et al. (2011) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2011.10.016 · Cited by 67 · see citing works
Self-citationGraham, M. L., & Schuurman, H. (2015) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2015.02.054 · Cited by 64 · see citing works
Self-citationWorking in partnership to advance the 3Rs in toxicity testing
Holmes, A. M., Creton, S. K., & Chapman, K. L. (2009) · Toxicology · doi:10.1016/j.tox.2009.11.006 · Cited by 62 · see citing works
Self-citationPractical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies
Lynch, C. M., Hart, B. W., & Grewal, I. S. (2009) · mAbs · doi:10.4161/mabs.1.1.7377 · Cited by 59 · see citing works
Functional assessment of sexual maturity in male macaques (Macaca fascicularis)
Luetjens, C. M., & Weinbauer, G. F. (2012) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2012.05.003 · Cited by 59 · see citing works
Auyeung-Kim, D. J., Devalaraja, M. N., Migone, T., Cai, W., & Chellman, G. J. (2009) · Reproductive Toxicology · doi:10.1016/j.reprotox.2009.07.002 · Cited by 58 · see citing works
Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals
Vargas, H. M., Amouzadeh, H. R., & Engwall, M. J. A. (2012) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2013.745851 · Cited by 55 · see citing works
Sasseville, V. G., & Mansfield, K. G. (2009) · Journal of Immunotoxicology · doi:10.3109/15476910903213521 · Cited by 54 · see citing works
Translational strategies for development of monoclonal antibodies from discovery to the clinic
Tabrizi, M. A., Bornstein, G. G., Klakamp, S. L., Drake, A. W., Knight, R., & Roskos, L. K. (2009) · Drug Discovery Today · doi:10.1016/j.drudis.2008.12.008 · Cited by 53 · see citing works
Impact of Infections and Normal Flora in Nonhuman Primates on Drug Development
Sasseville, V. G., & DITERS, R. W. (2008) · ILAR Journal · doi:10.1093/ilar.49.2.179 · Cited by 50 · see citing works
Considerations Regarding Nonhuman Primate Use in Safety Assessment of Biopharmaceuticals
Buckley, L. A., Chapman, K. L., Burns‐Naas, L. A., Todd, M. D., Martin, P. L., & Lansita, J. A. (2011) · International Journal of Toxicology · doi:10.1177/1091581811415875 · Cited by 43 · see citing works
Self-citationThe future of non-human primate use in mAb development
Chapman, K. L., Pullen, N., Andrews, L., & Ragan, I. (2010) · Drug Discovery Today · doi:10.1016/j.drudis.2010.01.002 · Cited by 43 · see citing works
Self-citationProtein drug delivery: current dosage form profile and formulation strategies
Geraldes, D. C., Beraldo-de-Araújo, V. L., Pardo, B. O. P., Pessoa, A., Stephano, M. A., & Nascimento, L. D. O. (2019) · Journal of drug targeting · doi:10.1080/1061186x.2019.1669043 · Cited by 40 · see citing works
Trist, H. M., Tan, P. S., Wines, B. D., Ramsland, P. A., Orlowski, E., Stubbs, J., Gardiner, E. E., Pietersz, G. A., Kent, S. J., Stratov, I., et al. (2013) · The Journal of Immunology · doi:10.4049/jimmunol.1301554 · Cited by 39 · see citing works
Preclinical Development of Nononcogenic Drugs (Small and Large Molecules)
Colerangle, J. B. (2017) · A Comprehensive Guide to Toxicology in Nonclinical Drug Development · doi:10.1016/b978-0-12-803620-4.00025-6 · Cited by 37 · see citing works
A methodological review of induced animal models of autoimmune diseases
Yu, X., & Petersen, F. (2018) · Autoimmunity Reviews · doi:10.1016/j.autrev.2018.03.001 · Cited by 38 · see citing works
Chapman, K. L., Adjei, A., Baldrick, P., da Silva, A., Smet, K. D., DiCicco, R. L., Hong, S. S., Jones, D., Leach, M. W., McBlane, J. W., et al. (2016) · mAbs · doi:10.1080/19420862.2016.1145331 · Cited by 36 · see citing works
Self-citationCollagen-induced arthritis in common marmosets: a new nonhuman primate model for chronic arthritis
Vierboom, M., Breedveld, E., Kondova, I. I., & Hart, B. A. ‘. (2010) · Arthritis Research & Therapy · doi:10.1186/ar3172 · Cited by 36 · see citing works
The enhanced pre‐ and postnatal study for nonhuman primates: Update and perspectives
Weinbauer, G. F., Fuchs, A., Niehaus, M., & Luetjens, C. M. (2011) · Birth Defects Research Part C Embryo Today Reviews · doi:10.1002/bdrc.20220 · Cited by 36 · see citing works
A snapshot of biologic drug development
Andrews, L., Ralston, S. L., Blomme, E. A. G., & Barnhart, K. F. (2015) · Human & Experimental Toxicology · doi:10.1177/0960327115603594 · Cited by 36 · see citing works
Ueda, O., Tateishi, H., Higuchi, Y., Fujii, E., Kato, A., Kawase, Y., Wada, N. A., Tachibe, T., Kakefuda, M., Goto, C., et al. (2013) · Scientific Reports · doi:10.1038/srep01196 · Cited by 35 · see citing works
Application of Quantitative Pharmacology in Development of Therapeutic Monoclonal Antibodies
Tabrizi, M. A., Funelas, C. B., & Suria, H. (2010) · The AAPS Journal · doi:10.1208/s12248-010-9220-2 · Cited by 35 · see citing works
Typical pitfalls in applications for marketing authorization of biotechnological products in Europe
Schneider, C. K., & Schäffner-Dallmann, G. (2008) · Nature Reviews Drug Discovery · doi:10.1038/nrd2728 · Cited by 35 · see citing works
Clinical Development Strategies and Outcomes in First-in-Human Trials of Monoclonal Antibodies
Tosi, D., Laghzali, Y., Vinches, M., Alexandre, M., Homicsko, K., Fasolo, A., Del Conte, G., Durigova, A., Hayaoui, N., Gourgou, S., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2014.58.1082 · Cited by 33 · see citing works
Human IgG subclass cross-species reactivity to mouse and cynomolgus monkey Fcγ receptors
Derebe, M. G., Nanjunda, R. K., Gilliland, G. L., Lacy, E. R., & Chiu, M. L. (2018) · Immunology Letters · doi:10.1016/j.imlet.2018.02.006 · Cited by 33 · see citing works
Sewell, F. R., Chapman, K. L., Couch, J. A., Dempster, M., Heidel, S. M., Loberg, L. I., Maier, C. C., MacLachlan, T. K., Todd, M. D., & van der Laan, J. W. (2017) · mAbs · doi:10.1080/19420862.2017.1324376 · Cited by 31 · see citing works
Self-citationUbah, O. C., Steven, J., Porter, A. J., & Barelle, C. J. (2019) · Frontiers in Immunology · doi:10.3389/fimmu.2019.00526 · Cited by 28 · see citing works
Biologics in organ transplantation
Page, E. K., Dar, W. A., & Knechtle, S. J. (2012) · Transplant International · doi:10.1111/j.1432-2277.2012.01456.x · Cited by 29 · see citing works
Niehoff, M. O., Bergmann, M., & Weinbauer, G. F. (2009) · Reproductive Toxicology · doi:10.1016/j.reprotox.2009.09.007 · Cited by 28 · see citing works
Buckley, L. A., Benson, K. A., Davis-Bruno, K. L., Dempster, M., Finch, G. L., Harlow, P., Haggerty, H. G., Hart, T. K., Kinter, L. B., Leighton, J. K., et al. (2008) · International Journal of Toxicology · doi:10.1080/10915810802367016 · Cited by 28 · see citing works
Poirier, N., Mary, C., Bas‐Bernardet, S. L., Daguin, V., Belarif, L., Chevalier, M., Hervouet, J., Minault, D., Ville, S., Charpy, V., et al. (2014) · mAbs · doi:10.4161/mabs.28375 · Cited by 26 · see citing works
How Biologics Have Changed the Drug Discovery Landscape
McGonigle, P. (2024) · The Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev-pharmtox-061724-080811 · Cited by 26 · see citing works
van Mierlo, G. J. D., Cnubben, N. H. P., Wouters, D., Wolbink, G., Hart, M. H. L., Rispens, T., Ganderup, N., Kuper, C. F., Aarden, L. A., & Penninks, A. (2013) · Journal of Immunotoxicology · doi:10.3109/1547691x.2013.796023 · Cited by 25 · see citing works
Development of Antibody-Based Therapeutics
Tabrizi, M. A., Klakamp, S. L., & Bornstein, G. G. (2012) · Springer eBooks · doi:10.1007/978-1-4419-5955-3 · Cited by 22 · see citing works
The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies
Weinbauer, G. F., Luft, J., & Fuchs, A. (2012) · Methods in molecular biology · doi:10.1007/978-1-62703-131-8_15 · Cited by 22 · see citing works
Immunotoxicity Testing in Nonhuman Primates
Grote-Wessels, S., Frings, W., Smith, C. A., & Weinbauer, G. F. (2009) · Methods in molecular biology · doi:10.1007/978-1-60761-401-2_23 · Cited by 20 · see citing works
The Evolving Landscape of Cancer Therapeutics
Khan, M. M., & Spicer, J. F. (2019) · Handbook of experimental pharmacology · doi:10.1007/164_2019_312 · Cited by 18 · see citing works
Chamanza, R., Naylor, S. W., Gregori, M., Boyle, M., Bacares, M. E. P., Drevon-Gaillot, E., Romeike, A., Courtney, C. L., Johnson, K. A., Turner, J. C., et al. (2022) · Toxicologic Pathology · doi:10.1177/01926233221096424 · Cited by 17 · see citing works
Preclinical Safety Evaluation of Monoclonal Antibodies
Lynch, C. M., & Grewal, I. S. (2007) · Handbook of experimental pharmacology · doi:10.1007/978-3-540-73259-4_2 · Cited by 15 · see citing works
Bioengineering translational models of lymphoid tissues
Michaels, Y. S., Buchanan, C. F., Gjorevski, N., & Moisan, A. (2023) · Nature Reviews Bioengineering · doi:10.1038/s44222-023-00101-0 · Cited by 15 · see citing works
Horai, N., Nagaoka, T., Higuchi, I., Kasai, H., Yoshioka, T., Umekita, Y., Fukuzaki, K., Nagata, R., Miyata, A., & Abeyama, K. (2013) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-14-205 · Cited by 15 · see citing works
From laboratory to Phase I/II cancer trials with recombinant biotherapeutics
Tolner, B., Smith, L., Hillyer, T., Bhatia, J., Beckett, P., Robson, L., Sharma, S. K., Griffin, N., Vervecken, W., Contreras, R., et al. (2007) · European Journal of Cancer · doi:10.1016/j.ejca.2007.08.027 · Cited by 14 · see citing works
Piccotti, J. R., Lebrec, H. N., Evans, E., Herzyk, D. J., Hastings, K. L., Burns‐Naas, L. A., Gourley, I. S., Wierda, D., & Kawabata, T. T. (2009) · Journal of Immunotoxicology · doi:10.1080/15476910802656440 · Cited by 12 · see citing works
Drug Development and Nonclinical to Clinical Translational Databases
Monticello, T. M. (2014) · Toxicologic Pathology · doi:10.1177/0192623314557189 · Cited by 12 · see citing works
Monoclonal Antibodies for Cancer Immunotherapy
Zarnani, A., Bozorgmehr, M., Shabani, M., Leila, B. Y., Ghaemimanesh, F., & Jeddi‐Tehrani, M. (2014) · Springer eBooks · doi:10.1007/978-3-662-44946-2_16 · Cited by 11 · see citing works
Singh, S., Kachhawaha, K., & Singh, S. K. (2024) · Biochemical Pharmacology · doi:10.1016/j.bcp.2024.116303 · Cited by 9 · see citing works
Preclinical evaluation of anti-rheumatic drugs in a non-human primate model of arthritic disease
Vierboom, M., Breedveld, E., & Hart, B. A. ‘. (2008) · Drug Discovery Today Disease Models · doi:10.1016/j.ddmod.2008.06.003 · Cited by 9 · see citing works
Zhang, K., Zhao, Y., Zhang, Z., Zhang, M., Wu, X., Bian, H., Zhu, P., & Chen, Z. (2020) · Acta Pharmaceutica Sinica B · doi:10.1016/j.apsb.2020.06.011 · Cited by 7 · see citing works
Primate autoimmune disease models; lost for translation?
Hart, B. A. ‘. (2016) · Clinical & Translational Immunology · doi:10.1038/cti.2016.82 · Cited by 7 · see citing works
Embryo fetal Development Studies in Nonhuman Primates
Fuchs, A., Buse, E., & Weinbauer, G. F. (2012) · Methods in molecular biology · doi:10.1007/978-1-62703-131-8_14 · Cited by 6 · see citing works
Formulation development of small and large volume injections
Kamat, M. S., & DeLuca, P. P. (2012) · CRC Press eBooks · doi:10.3109/9781420086447-6 · Cited by 6 · see citing works
Monoclonal Antibodies for Cancer Immunotherapy
Zarnani, A., Jafari, D., Bozorgmehr, M., Shabani, M., Leila, B. Y., Ghaemimanesh, F., & Jeddi‐Tehrani, M. (2020) · Springer eBooks · doi:10.1007/978-3-030-50287-4_15 · Cited by 6 · see citing works
The Use of the Marmoset in Toxicity Testing and Nonclinical Safety Assessment Studies
Korte, S., & Everitt, J. I. (2018) · Elsevier eBooks · doi:10.1016/b978-0-12-811829-0.00027-3 · Cited by 6 · see citing works
A novel preclinical model for rheumatoid arthritis research
Petersen, F., & Yu, X. (2010) · Arthritis Research & Therapy · doi:10.1186/ar3181 · Cited by 6 · see citing works
Nguyen, N. M., Mukai, R., Nita, M., Yokoyama, F., Nguyen, N.-L. T., Horiuchi, J., & Kumada, Y. (2025) · Analytical Chemistry · doi:10.1021/acs.analchem.5c04510 · Cited by 5 · see citing works
Safety Pharmacology Assessment of Biopharmaceuticals
Amouzadeh, H. R., & Vargas, H. M. (2013) · Springer eBooks · doi:10.1007/978-3-642-25240-2_18 · Cited by 5 · see citing works
Interactions of human IgGs with non-human systems
(2012) · Elsevier eBooks · doi:10.1533/9781908818096.405 · Cited by 4 · see citing works
Chapman, K. L., Bayne, K. A. L., Couch, J. A., Decelle, T., Finch, J. M., de Haan, L., Koban, T., Mikkelsen, L. F., Müller, W., Palmer, H. S., et al. (2015) · Elsevier eBooks · doi:10.1016/b978-0-12-417144-2.00014-7 · Cited by 4 · see citing works
Self-citationA primate as an animal model for reproductive and developmental toxicity testing
Faqi, A. S. (2011) · Elsevier eBooks · doi:10.1016/b978-0-12-382032-7.10017-7 · Cited by 3 · see citing works
Kumar, B., Kumar, P., Krishna, T. P., Kalyanasundaram, S., Suresh, P., Jagadeesan, V., Hariharan, S., Naidu, A. N., Krishnaswamy, K., Rangarajan, P. N., et al. (2013) · Europe PMC (PubMed Central) · Cited by 3 · see citing works
Developmental and reproductive safety assessment of biopharmaceuticals
Bowman, C., & Martin, P. L. (2016) · CRC Press eBooks · doi:10.3109/9781841848211-21 · Cited by 3 · see citing works
Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)
Colerangle, J. B. (2012) · Elsevier eBooks · doi:10.1016/b978-0-12-387815-1.00022-8 · Cited by 3 · see citing works
Optimising the Development of Antibodies as Treatment for Cancer
Carden, C. P., Arkenau, H., & Bono, J. S. D. (2010) · Springer eBooks · doi:10.1007/978-1-4419-7358-0_19 · Cited by 3 · see citing works
Preclinical Safety Considerations for the Development of Antibody-Based Therapeutics
de Haan, L. (2012) · Springer eBooks · doi:10.1007/978-1-4419-5955-3_10 · Cited by 3 · see citing works
Nonhuman primates as preclinical models for developmental and reproductive toxicity evaluation
Weinbauer, G. F., Fuchs, A., Luetjens, C. M., Niehaus, M., Niehoff, M. O., & Vogelwedde, E. (2011) · Informa Healthcare eBooks · doi:10.3109/9781841848211.016 · Cited by 2 · see citing works
Regulations and ethics concerning the use of non-human primates in research
Harvey, W., & Kaiser, R. A. (2023) · Elsevier eBooks · doi:10.1016/b978-0-12-813088-9.00003-3 · Cited by 2 · see citing works
Role of Nonclinical Programs in Drug Development
Srivastava, A. K., & Negi, G. (2023) · Springer eBooks · doi:10.1007/978-981-99-1284-1_35 · Cited by 2 · see citing works
Lu, J., Dou, D., Wang, Y., Shu, J., Lei, Z., Huo, Y., & Gong, X. (2025) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2025.105814 · Cited by 2 · see citing works
Nonhuman primates as preclinical models for developmental and reproductive toxicity evaluation
Weinbauer, G. F., Fuchs, A., Luetjens, C. M., Niehaus, M., Niehoff, M. O., & Vogelwedde, E. (2016) · CRC Press eBooks · doi:10.3109/9781841848211-20 · Cited by 2 · see citing works
Safety Assessment in Drug Discovery
Sasseville, V. G., Foster, W. R., & Car, B. D. (2009) · doi:10.1002/9780470574898.ch9 · Cited by 2 · see citing works
Kubota, S., Saito, K., Ono, S., & Kodama, Y. (2016) · Drugs in R&D · doi:10.1007/s40268-016-0160-x · Cited by 1 · see citing works
Vallance, P. J. (2009) · Elsevier eBooks · doi:10.1016/b978-1-4160-3291-5.50005-6 · Cited by 1 · see citing works
Biopharmaceutics of NCEs and NBEs
Agoram, B. M., Sagawa, K., Shanker, R., & Singh, S. K. (2012) · CRC Press eBooks · doi:10.3109/9781420086447-4 · Cited by 1 · see citing works
Katavolos, P., Prell, R. A., Zane, D., Deng, R., & Halpern, W. (2018) · Birth Defects Research · doi:10.1002/bdr2.1402 · Cited by 1 · see citing works
Biopharmaceuticals as Challenges to the Regulatory System
Ebbers, H. C. (2012) · Utrecht University Repository (Utrecht University) · Cited by 1 · see citing works
Implementation of ICH S 6: EU Perspective
Ryle, P. R., & Snodin, D. J. (2010) · Pharmaceutical Sciences Encyclopedia · doi:10.1002/9780470571224.pse163 · Cited by 1 · see citing works
In vivoMethods for Oral Bioavailability Studies
Ruiz-Garcı́a, A., & Bermejo, M. (2011) · doi:10.1002/9781118067598.ch31 · Cited by 1 · see citing works
Antibody drugs: the present status and perspectives
Kawanishi, T. (2008) · Folia Pharmacologica Japonica · doi:10.1254/fpj.131.102 · Cited by 1 · see citing works
Barsch, M., & Otte, A. (2010) · PubMed · Cited by 1 · see citing works
Pre-clinical strategies and safety issues in developing therapeutic monoclonal antibodies
Chamberlain, P. (2011) · New Biotechnology · doi:10.1016/j.nbt.2011.03.017 · Cited by 1 · see citing works
(2012) · Elsevier eBooks · doi:10.1016/b978-1-907568-37-4.50029-4 · Cited by 1 · see citing works
- Authors
- Chapman, K., Pullen, N., Graham, M., & Ragan, I.
- Affiliations
- National Centre for the Replacement Refinement and Reduction of Animals in Research (GB)
- Pfizer (United Kingdom) (GB)
- AstraZeneca (United Kingdom) (GB)
- Eli Lilly (United Kingdom) (GB)
- Corresponding author
- Chapman, Kathryn
- Venue
- Nature Reviews Drug Discovery
- Published
- 2007-02
- Volume
- 6
- Issue
- 2
- Pages
- 120-126
- ISSN
- 1474-1776 (ISSN-L)
- 1474-1784
- OpenAlex
- W2064876070
- Cited by
- 121
- References
- 18
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 6 · 2022: 1 · 2021: 1 · 2020: 2 · 2019: 4 · 2018: 7 · 2017: 2 · 2016: 7 · 2015: 7 · 2014: 5 · 2013: 11 · 2012: 16
- FWCI
- 2.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Nature Reviews Drug Discovery (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Centre for the Replacement, Refinement and Reduction of Animals in Research
- National Centre for the Replacement Refinement and Reduction of Animals in Research
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- monoclonal antibodies, preclinical safety, non-human primates, animal ethics, translational animal model
- MeSH terms
- Animals, Antibodies, Monoclonal, Drug Evaluation, Preclinical, Primates, Toxicity Tests, Animals, Genetically Modified
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