Advanced search
Publication Cover
Journal of Immunotoxicology Volume 10, 2013 - Issue 1
Submit an article Journal homepage
1,396
Views
14
CrossRef citations to date
0
Altmetric
Paper from the 20th Summerschool in Immunotoxicology, Beaune, France, Sept. 26–28, 2011

The Göttingen minipig® as an alternative non-rodent species for immunogenicity testing: A demonstrator study using the IL-1 receptor antagonist anakinra

Geertje J. D. van MierloDepartment of Toxicology and Risk Assessment, TNO Triskelion BV, Zeist, The NetherlandsCorrespondence[email protected]
,
Nicole H. P. CnubbenDepartment of Toxicology and Risk Assessment, TNO Triskelion BV, Zeist, The Netherlands
,
C. Frieke KuperTNO Earth, Environmental and Life Sciences, Zeist, The Netherlands
,
Jasja WolthoornDepartment of Analytical Research, TNO Triskelion BV, Zeist, The Netherlands
,
Angelique P. van Meeteren-KreikampDepartment of Analytical Research, TNO Triskelion BV, Zeist, The Netherlands
,
Machiel M. NagtegaalDepartment of Analytical Research, TNO Triskelion BV, Zeist, The Netherlands
,
Robert Doornbos
,
Niels-Christian GanderupEllegaard Göttingen Minipigs, Dalmose, Denmark
&
André H. PenninksDepartment of Toxicology and Risk Assessment, TNO Triskelion BV, Zeist, The Netherlands
 show all
Pages 96-105 | Received 02 Jul 2012, Accepted 25 Sep 2012, Published online: 07 Nov 2012

References

  • Bode, G., Clausing, P., Gervais, F., Loegsted, J., Luft, J., Nogues, V., Sims, J. 2010. The utility of the minipig as an animal model in regulatory toxicology. J. Pharmacol. Toxicol. Meth. 62:196–220.
  • Brinks, V., Jiskoot, W., Schellekens, H. 2011. Immunogenicity of therapeutic proteins: The use of animal models. Pharm. Res. 28:2379–2385.
  • Bugelski, P. J., Treacy, G. 2004. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans.Curr. Opin. Mol. Ther. 6:10–16.
  • Buttel, I. C., Chamberlain, P., Chowers, Y., Ehmann, F., Greinacher, A., Jefferis, R., Kramer, D., Kropshofer, H., Lloyd, P., Lubiniecki, A., Krause, R., Mire-Sluis, A., Platts-Mills, T., Ragheb, J. A., Reipert, B. M., Schellekens, H., Seitz, R., Stas, P., Subramanyam, M., Thorpe, R., Trouvin, J. H., Weise, M., Windisch, J., Schneider, C. K. 2011. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 39:100–109.
  • Chirino, A. J., Ary, M. L., Marshall, S. A. 2004. Minimizing the immunogenicity of protein therapeutics. Drug Discov. Today 9:82–90.
  • EMEA. 2006. Kineret: EPAR - Scientific Discussion.
  • FDA. 2000. Center for drug evaluation and research and center for biologics evaluation and research. Application number 103950/0.
  • FDA. 2001. Center for drug evaluation and research and center for biologics evaluation and research. Application number 103950/0; Approved labeling.
  • FDA (Food and Drug Administration) Arthritis Drugs Advisory Committee. 2001. Kineret TM (anakinra) FDA Arthritis Drugs Advisory Committee Briefing Package.
  • Forster, R., Ancian, P., Fredholm, M., Simianer, H., Whitelaw, B. 2010a. The minipig as a platform for new technologies in toxicology. J. Pharmacol. Toxicol. Meth. 62:227–235.
  • Forster, R., Bode, G., Ellegaard, L., van der Laan, J. W. 2010b. The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: Conclusions and recommendations. J. Pharmacol. Toxicol. Meth. 62:236–242.
  • Forster, R., Bode, G., Ellegaard, L., van der Laan, J. W. 2010c. The RETHINK project -minipigs as models for the toxicity testing of new medicines and chemicals: An impact assessment. J. Pharmacol. Toxicol. Meth. 62:158–159.
  • Getts, D. R., Getts, M. T., McCarthy, D. P., Chastain, E. M., Miller, S. D. 2010. Have we over-estimated the benefit of human(ized) antibodies? MAbs 2:682–694.
  • ICH. 2005. ICH S8. Immunotoxicity Studies for Human Pharmaceuticals.
  • Kromminga, A., Schellekens, H. 2005. Antibodies against erythropoietin and other protein-based therapeutics: An overview. Ann. NY Acad. Sci. 1050:257–265.
  • Penninks, A. H., van Mierlo, G. J. 2012. Immunotoxicity studies in minipigs. In: The Minipig in Biomedical Research (McAnulty, P. A., Dayan, A. D., Ganderup, N. C.Hastings, K. L., Eds.). New York: CRC Press/Taylor and Francis Group, pp. 397–414.
  • Ponce, R., Abad, L., Amaravadi, L., Gelzleichter, T., Gore, E., Green, J., Gupta, S., Herzyk, D., Hurst, C., Ivens, I. A., Kawabata, T., Maier, C., Mounho, B., Rup, B., Shankar, G., Smith, H., Thomas, P., Wierda, D. 2009. Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 54:164–182.
  • Regulatory Affairs Canada. 2008. Product Monograph PrKineret.
  • Schellekens, H. 2010. The immunogenicity of therapeutic proteins. Discov. Med. 9:560–564.
  • Singh, S. K. 2011. Impact of product-related factors on immunogenicity of biotherapeutics.J. Pharm. Sci. 100:354–387.
  • van der Laan, J. W., Brightwell, J., McAnulty, P., Ratky, J., Stark, C. 2010. Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals, and other products. J. Pharmacol. Toxicol. Meth. 62:184–195.
  • Wierda, D., Smith, H. W., Zwickl, C. M. 2001. Immunogenicity of biopharmaceuticals in laboratory animals. Toxicology 158:71–74.
  • Zuurmond, A. M., Koudijs, A., van, E. B., Doornbos, R. P., van Manen-Vernooij, B. C., Bastiaans, J. H., Penninks, A. H., van Bilsen, J. H., Cnubben, N. H., Degroot, J. 2011. Integration of efficacy, pharmacokinetic, and safety assessment of IL-1 receptor antagonist in a pre-clinical model of arthritis. Regul. Toxicol. Pharmacol. 59:461–470.

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.