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Preclinical safety testing of monoclonal antibodies: the significance of species relevance

Nature Reviews Drug Discovery volume 6, pages 120–126 (2007)Cite this article

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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Figure 1: Schematic representation of preclinical studies.

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Acknowledgements

The National Centre for the Replacement, Refinement and Reduction of Animals in Research expresses its sincere thanks to all speakers and delegates at the workshop. Particular thanks to V. Robinson and P. Round for help in developing the concepts in this article.

Author information

Authors and Affiliations

  1. the National Centre for the Replacement, Refinement and Reduction of Animals in Research, 20 Park Crescent, London, W1B 1AL, UK

    Kathryn Chapman

  2. Pfizer Global Research & Development, Ramsgate Road, Sandwich, CT13 9NJ, Kent, UK

    Nick Pullen

  3. AstraZeneca, Safety Assessment, Loughborough, LE12 8QQ, Bakewell Road, Leicestershire, UK

    Mark Graham

  4. Visiting Professor (Toxicology) at University of Surrey, Guildford, GU2 7XH, Surrey, UK

    Mark Graham

  5. Eli Lilly, Lilly Research Centre, Windlesham, GU20 6PH, Surrey, UK

    Ian Ragan

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  1. Kathryn Chapman
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  2. Nick Pullen
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Corresponding author

Correspondence to Kathryn Chapman.

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The authors declare no competing financial interests.

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FURTHER INFORMATION

Association of the British Pharmaceutical Industry

The National Centre for the Replacement, Refinement and Reduction of Animals in Research

World Medical Association Declaration of Helsinki

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Chapman, K., Pullen, N., Graham, M. et al. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov 6, 120–126 (2007). https://doi.org/10.1038/nrd2242

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