Genetic Toxicology Studies and Services

Aurigene is committed to provide rapid and solution-driven genetic toxicology services to the clients.

Preclinical genetic toxicology studies are crucial for assessing the potential genetic risks of new drugs and chemicals before they are tested in humans. These studies help identify substances that may cause genetic mutations, chromosomal damage, or other genetic alterations that could lead to cancer or other genetic diseases. Here's a comprehensive overview of our capabilities at Aurigene:

Mutagenicity Testing: To determine if a substance can cause genetic mutations.
Clastogenicity Testing: To assess if a substance can cause structural changes in chromosomes.
Genotoxicity Testing: To evaluate the overall potential of a substance to damage genetic material.

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Types of Genetic Toxicology Tests

Ames Test

We use Salmonella typhimurium and E. Coli tester strains to assess mutations of a test article. Ames test is a rapid and reliable bacterial assay used for evaluating a chemical's potential genotoxicity by measuring its ability to induce reverse mutations at selected loci of modified Salmonella and E. coli bacterial strains. These strains have various mutations and are not capable of synthesizing an essential amino acid, either histidine (Salmonella) or tryptophan (E. coli), so they can only grow in the culture medium that is supplemented with that amino acid. Once the bacteria are exposed to a mutagen, mutation(s) occur that could restore/reverse the ability of the bacteria to synthesize the amino acid and to continue growth even after depletion of traces of provided amino acid in the agar. Relevant mutations involve substitution of individual base pairs or frameshift mutations caused by addition or deletion of a stretch of DNA. The Ames test can be carried out in the presence and absence of a metabolizing system to identify potential mutagenicity by the parent compound and/or its metabolites.

Mini Ames

For repeated and multiple screenings, we provide Mini Ames Test by using TA98/TA100/E. coli wp2 strains; Non-GLP screening assay to evaluate the multiple compounds in each step especially where test items are accessible at very less quantity.

Ames-Fluctuation assay

We make the screening much more convenient by adding the one more high-throughput fluctuation assay. The extra added advantage in this service is which requires a very small amount of compound, i.e., less than 50 mg. This is a 384-well plate method where Salmonella strains, TA98, TA100, TA1535, and TA1537 will be tested by exposing the test item in the exposure liquid purple color media and mutations indicated as yellow color colonies after incubation.

Mammalian Cell Assays

At Aurigene, we carry out the in vitro mouse lymphoma assay, the chromosomal aberration assay and the micronucleus assay. The in vitro chromosomal aberration and micronucleus assays are conducted both in vitro and in vivo.

The Micronucleus Test is a reliable and commonly-employed test to meet the regulatory requirements while submitting IND, to screen the compounds (such as chemicals, impurities, pesticides, insecticides, food and feed additives) for their clastogenic potential in bone marrow of rodents (rats/mice) and as a component of exposure-based risk assessment. This assay plays a vital role in adding weight of evidence in the hazardous measurement of any chemical and quantitative risk assessments.

The Chromosomal Aberration Test (CAT) is routinely employed to meet regulatory expectation to screen the compounds (such as chemicals, impurities, pesticides, insecticides, food and feed additives) for their clastogenic potential to cells (human blood lymphocytes or mammalian cell lines in culture) by evaluating the development gene/chromosome damage in the form of structural aberrations at chromosome level.

Regulatory agencies like the FDA and EMA require genetic toxicology testing as part of the safety assessment for new drugs and chemicals. The genetic toxicology facility of Aurigene complies with Good Laboratory Practice (GLP) standards to ensure reliability and reproducibility

Preclinical genetic toxicology studies are essential for ensuring the safety of new drugs and chemicals. By identifying potential genetic risks early, these studies help prevent harmful substances from reaching clinical trials and, ultimately, the market.

Why Aurigene Pharmaceutical Services?

Quick turnaround time

Extensive experience in the genetic toxicology studies

Team of expert analytical and toxicology scientists

State-of-the-art facilities

Other Services

Carcinogenicity Studies and Services

General Toxicology Services

In vitro Genotoxicity Testing Services

Reproductive Toxicity Studies

Safety Pharmacology Studies and Services

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Hyderabad R and D Center

Bangalore R and D Center

Toxicology Studies

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We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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