The future of non-human primate use in mAb development

Drug Discovery Today

Volumn 15, Issue 5-6, 2010, Pages 235-242

  Chapman, Kathryn L ^a   Pullen, Nick ^b   Andrews, Laura ^c   Ragan, Ian ^d  

^a National Centre for the Replacement   (United Kingdom)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^c Genzyme   (United States)

^d CIR Consulting Ltd ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ANIMAL TESTING ALTERNATIVE; ANIMAL TESTING REDUCTION; ANIMAL TESTING REFINEMENT; ANIMAL TESTING REPLACEMENT; DRUG INDUSTRY; DRUG POTENCY; DRUG RESEARCH; DRUG SAFETY; EUROPEAN UNION; MACACA; NONHUMAN; PREDICTION; PRIMATE; REVIEW; SCIENCE; SPECIES DIFFERENCE; TOXICITY TESTING;

ANIMALS; ANTIBODIES, MONOCLONAL; DISEASE MODELS, ANIMAL; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; FORECASTING; HUMANS; MACACA FASCICULARIS;

EID: 77949275859     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2010.01.002     Document Type: Review

References (30)

1. Scientific Committee on Health and Environmental Risks SCHER (2009) The need for non-human primates in biomedical research, production and testing of products and devices (http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_110 .pdf)
2. Weatherall, D. et al. (2006) The use of non-human primates in research (http://www.acmedsci.ac.uk/images/project/nhpdownl.pdf)
3. UK Home Office (2008) Statistics of scientific procedures on living animals, Great Britain (http://www.homeoffice.gov.uk/rds/pdfs09/spanimals08.pdf)
4. United States Department of Agriculture Animal and Plant Health Inspection Service (2007) Animal care annual report of activities (http://www.aphis.usda.gov/publications/animal_welfare/content/ printable_version/2007_AC_Report.pdf), p. 13
5. Tabrizi M.A., and Roskos L.K. Preclinical and clinical safety of monoclonal antibodies. Drug Discov. Today 12 (2007) 540-547
6. Tabrizi M.A., et al. Translational strategies for development of monoclonal antibodies from discovery to the clinic. Drug Discov. Today 14 (2009) 358-372
7. Lynch C.M., and Grewal I.S. Preclinical safety evaluation of monoclonal antibodies. Handb. Exp. Pharmacol. 181 (2008) 19-44
8. Buckley L.A., et al. Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop. Int. J. Toxicol. 27 (2008) 303-312
9. Chapman K., et al. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat. Rev. Drug Discov. 6 (2007) 120-126
10. Schneider C.K. Monoclonal antibodies - regulatory challenges. Curr. Pharm. Biotechnol. 9 (2008) 431-438
11. Reichert J.M. Monoclonal antibodies as innovative therapies. Curr. Pharm. Biotechnol. 9 (2008) 423-430
12. Malik N.N. Biotech acquisitions by big pharma: why and what is next. Drug Discov. Today 14 (2009) 818-821
13. Martin P.L., et al. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Birth Defects Res. B: Dev. Reprod. Toxicol. 86 (2009) 176-203
14. Pentsuk N., and van der Laan J.W. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res. 86 (2009) 328-344
15. Simister N.E. Placental transport of immunoglobulin G. Vaccine 21 (2003) 3365-3369
16. European Medicines Agency (EMEA) European public assessment report for MabThera (http://www.emea.europa.eu/humandocs/Humans/EPAR/mabthera/mabthera.htm)
17. European Medicines Agency (EMEA) European public assessment report for Erbitux (http://www.emea.europa.eu/humandocs/Humans/EPAR/erbitux/erbitux.htm)
18. Clarke J., et al. Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody. Regul. Toxicol. Pharmacol. 40 (2004) 219-226
19. European Medicines Agency (EMEA) European public assessment report for Raptiva (http://www.emea.europa.eu/humandocs/Humans/EPAR/raptiva/raptiva.htm)
20. Treacy G. Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanised anti-TNFα monoclonal antibody. Hum. Exp. Toxicol. 19 (2000) 226-228
21. European Medicines Agency (EMEA) European public assessment report for Remicade (http://www.emea.europa.eu/humandocs/Humans/EPAR/remicade/remicade.htm)
22. Suntharalingam G.M., et al. Cytokine storm in phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355 (2006) 1018-1028
23. Duff report. NIBSC Special Cytokine Study and Follow up study, pp. 56-67 (http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicat ionsPolicyAndGuidance/DH_063117)
24. Horvath C.J., and Milton M.N. The TeGenero incident and the Duff report conclusions: a series of unfortunate events or an avoidable event?. Toxicol. Pathol. 37 (2009) 372-383
25. Chapman K., et al. Preclinical development of monoclonal antibodies: considerations for the use of non-human primates. mAbs 1 (2009) 505-517
26. Bussiere J.L., et al. Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Int. J. Toxicol. 28 (2009) 230-253
27. Clarke J., et al. Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?. Regul. Toxicol. Pharmacol. 50 (2008) 2-22
28. Stewart J. Developmental toxicity testing of monoclonal antibodies: an enhanced pre- and postnatal study design option. Reprod. Toxicol. 28 (2009) 220-225
29. Bugelski P.J., et al. Preclinical development of keliximab, a primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies. Hum. Exp. Toxicol. 19 (2000) 230-243
30. Robinson S., et al. European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul. Toxicol. Pharmacol. 50 (2007) 345-352