Immunogenicity of biopharmaceuticals in laboratory animals

Toxicology. 2001 Feb 2;158(1-2):71-4. doi: 10.1016/s0300-483x(00)00410-8.


The potential immunogenicity of new protein therapeutics raises concerns about the possibility of inducing untoward immune reactions in humans. It is generally assumed that all animals will make antibody to human proteins and therefore, there is sentiment among some scientists that this makes the issue of immunogenicity as a safety concern irrelevant. However, recent clinical trials with some proteins have detected the presence of autoantibodies that have resulted in clinical sequelae. These reactions were also observed in preclinical animal studies. In fact, non-human primate and transgenic mouse models can be useful for predicting the relative immunogenicity of human proteins. In addition, the characterization of the immunogenicity of biotechnology molecules provides a practical basis for determining the significance of antibody formation in preclinical safety studies.

Publication types

  • Review

MeSH terms

  • Animals
  • Animals, Laboratory
  • Antibody Formation / drug effects
  • Antibody Formation / immunology
  • Biotechnology / methods
  • Drug Evaluation, Preclinical / methods*
  • Drug Hypersensitivity / etiology*
  • Drug-Related Side Effects and Adverse Reactions*
  • Immune System / drug effects*
  • Macaca mulatta
  • Mice
  • Mice, Transgenic
  • Recombinant Proteins / immunology*
  • Recombinant Proteins / toxicity*
  • Toxicity Tests / methods


  • Recombinant Proteins