Genetic toxicology studies are conducted during early stages of the safety testing program of pharmaceutical and biotechnology products. VIMTA conducts genetic toxicology studies in a tiered approach, starting with an Ames test and progressing to the conduct of mammalian cell and in vivo assays, which are designed to assess the toxicological relevance of any earlier observations. Our genetic toxicology capabilities include:
- Bacterial reverse mutation assay (Ames test)
- In vitromammalian cell gene mutation test in mouse lymphoma cells using the Tk gene and in CHO cells using the Hprt gene
- In vitromammalian chromosomal aberration test using human peripheral blood lymphocytes (HPBL), V79 cells and CHO cells
- In vitromicronucleus test in human peripheral blood lymphocytes (HPBL) and CHO cells
- In vivomicronucleus test in rat and mouse
- In vivochromosomal aberration