Fraunhofer-Verbund Life SciencesAs 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.
Tolerability studies in marmoset, rhesus, and cynomolgus macaque
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