Genetic toxicology studies are conducted during the early stages of safety testing for pharmaceutical and biotechnology products. VIMTA follows a tiered approach to genetic toxicology testing, beginning with the Ames test and progressing to mammalian cell and in vivo assays. These studies are designed to evaluate the toxicological significance of any findings observed during earlier stages of testing, providing robust data to support regulatory submissions and product safety assessments.
Our Genetic Toxicology capabilities include:
- Bacterial reverse mutation assay (Ames test)
- In vitro mammalian cell gene mutation test in mouse lymphoma cells using the Tk gene and in CHO cells using the Hprt gene
- In vitro mammalian chromosomal aberration test using human peripheral blood lymphocytes (HPBL), V79 cells, and CHO cells
- In vitro micronucleus test in human peripheral blood lymphocytes (HPBL) and CHO cells
- In vivo micronucleus test in rats and mice
- In vivo chromosomal aberration test
