Tolerability studies in marmoset, rhesus, and cynomolgus macaque

As a prerequisite for human clinical trials, preclinical studies have to confirm tolerability of test compounds in relevant species.  According to the S6 guideline for preclinical safety evaluation of biotechnology-derived pharmaceuticals, “a relevant species is one in which the test material is pharmacologically active due to the expression of the receptor or an epitope […]”. In case of biopharmaceuticals addressing human-specific target, non-human primates are often the only relevant species. A high sequence homology compared to humans allows an exceptional transferability of results obtained in preclinical studies. Here we provide the possibility to analyze effect of test compounds in non-human primates in vivo, as well as ex vivo.

Species

Marmoset (Callithrix jacchus), cynomolgus (Macaca fascicularis), rhesus macaque (Macaca mulatta)

Field of application

  • Preclinical safety testing

Endpoints/Outcome parameter

  • Inflammation, animal behavior

Readout parameter

  • Scoring for animal behavior
  • Blood analysis: cell count + differential cell count (incl. inflammatory cells), serology
  • Bronchoalveolar lavage: cell count + differential cell count (incl. inflammatory cells), cytokine profiles
  • Macropathology, Histopathology: conventional staining and tissue pathohistology/conventional microscopy (e.g. tissue cell infiltration), immunohistochemistry
  • Tissue analysis regarding compound distribution
  • Flow cytometric analysis
  • Precision-cut lung slices

Quality management and validation

  • Internal quality management
  • Historical data available
  • Accurate observance of EU directive 2010/63/EU on the protection of animals used for scientific purposes and of the German animal protection law

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