Genetic & in vitro Toxicology

Assess Risk and Reduce Cost

Genetic toxicology studies help you assess the potential for induction of genetic mutations or chromosomal damage and are an integral part of the basic toxicological information package used in the decision-making and risk assessment process of drug development.

Our genetic toxicologists can help you create a battery of tests that yield high-quality data, ensuring that you are aware of potential risk during subsequent development stages. This process results in saving you time and reducing your costs.

Genetic Toxicology Screening Assays

• Mini Ames assay
• Microwell micronucleus assay

Genetic Toxicology GLP Assays

• Ames assay
• In vitro chromosomal aberration assay
• In vitro micronucleus assay
• Mouse lymphoma assay
• In vivo micronucleus assay
• In vivo alkaline comet assay

In Silico Mutagenicity Prediction

The International Conference on Harmonization (ICH) M7 guidelines for the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals allows for the consideration of in silico predictions in place of in vitro studies. This represents a significant advance in the acceptance of Quantitative Structure-active Relationship (Q)SAR models.

Two complementing (Q)SAR prediction methodologies should be applied for predicting the outcome of a bacterial mutagenicity assay: one expert rule-based and the other statistical-based.

(Q)SAR Prediction

• Leadscope model applier (expert rule-based and statistical-based models)

Phototoxicity

Phototoxicity is defined as a toxic response elicited by topically or systemically administered photoreactive chemicals after the body’s exposure to environmental light.  Recommended by European Medical Agency (EMA) and ICH guidelines, the 3T3 Neutral Red Uptake (NRU) Phototoxicity (PT) assay is an established in vitro assay used extensively in the pharmaceutical industry.

GLP or Non-GLP In Vitro Phototoxicity Assay

• 3T3 NRU phototoxicity assay

In Vitro Electrophysiology

hERG (human ether-a-go-go-related gene) potassium current plays the crucial role in determining the repolarization of cardiac action potential. Blocking the hERG channel may cause QT interval prolongation resulting in Torsade de Pointes.

In vitro evaluation of drug effects on hERG potassium channels is a valuable tool for identifying potential proarrhythmic side effects in drug-safety testing. Implementation of the ICH S7B guideline has been successful in preventing the introduction of potentially torsadogenic drugs to the market.

 GLP or Non-GLP in vitro Electrophysiology Assay

• hERG assay