Chemicals compounds may exert adverse effect through interaction with genetic material (DNA) of cells. Therefore, genotoxicity tests are designed to detect drugs which can induce genetic damage directly or indirectly by various mechanisms of action. Compounds that have the genotoxic characterization in these tests can potentially be human carcinogens and/or mutagens, and ultimately may induce cancer and/or heritable defects.
Creative Animodel provides a comprehensive genetic toxicology liability assessment service to evaluate the genotoxic potential of pharmaceutical, biopharmaceutical, food additives, chemicals and animal health products. Genotoxicity testing is an integral component of regulatory toxicity evaluation in most countries. Approval and registration of new drugs requires genotoxicity tests to be done. A series of standard in vitro and in vivo tests for genotoxicity is recommended by regulatory agencies, these tests include:
In vitro assays
• Mutation in bacteria (Ames test), mammalian gene mutation (mouse lymphoma assay)
• Chromosome aberration (human lymphocytes and Chinese hamster ovary cells)
• Micronucleus (human lymphocytes and cell lines)
In vivo assays
• Rodent bone marrow micronucleus and chromosome aberrations
• Comet and combination (micronucleus and Comet)
Advantages of our genotoxicity platform:
• An experienced team with state-of-the-art technology to help you assess genetic risk
• Working closely with you to deliver regulatory-compliant reports.
• Study designs based on the most up-to-date guidelines
• Conducting genetic toxicology studies in a tiered approach, starting with an Ames test and progressing to the conduct of mammalian cell and in vivo assays.
Assessment of genotoxicity has evolved towards earlier stages of drug discovery. Identification of genotoxic liabilities at an early stage would help with decision making, thus the likelihood of late stage failures will be significantly reduced, which can help to save you time and resources in drug development.
We have worked in this field for years and have provide service for a wide range of industries to successfully assess the potential for genetic damage or identify genotoxic impurities in compound. With our extensive experience and technical expertise, we will be your best partner in genomic toxicity assessment.