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Genetic Toxicology - Ames, Chromosomal Aberration, Micronucleus

Genetic Toxicology

NUCRO-TECHNICS has a full service genetic toxicology department to support the genotoxic potential characterization of your compounds from screening to NDA submission. Nucro-Technics is capable of conducting testing of new Active Pharmaceutical Ingredients (APIs), biotechnology products, chemicals, and other agents. The wide array of test systems offered by Nucro-Technics satisfies the test requirements of the FDA, OECD, ICH, EPA, EU, EMEA, ISO, USP and Health Canada.

STANDARD REGULATORY GENETIC TOXICOLOGY TESTS

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), has issued  the Guidelines S2 (R1) on Genotoxicity Testing and Data Interpretation for pharmaceuticals Intended for Human Use. The following two battery options are acceptable according to the guidelines:

ICH S2R1
Test Category Test Battery 1 Test Battery 2
Bacterial Reverse Mutation Test (Example: Ames Assay) 1 assay 1 assay
In Vitro DNA Damage in Mammalian Cells (Example: In Vitro Chromosome Aberration Assay, Mouse Lymphoma Assay, In Vitro Micronucleus Assay) 1 assay none
In Vivo Test for Genetic Damage (Example: In Vivo Chromosome Aberration Assay, In Vivo Micronucleus Test) 1 assay 2 assays using different organs

GENETIC TOXICOLOGY SCREENING TESTS

The genetic toxicology screening tests are designed to reduce the amount of test article required (up to 60 times less compound) and shorten the turnaround time at a fraction of the price of a regulatory assay. If the information on a test article is limited, if flags for mutagenicity have been detected or a large number of test articles have to be analyzed, the genetic toxicology screening tests may be a better way to start the genotoxicity evaluation.

CYTOTOXICITY ASSAYS

Cytotoxicity assays may be used to screen for cytotoxicity in compound libraries in the R&D process or used as quality control required for regulatory bodies for product release. Nucro-Technics can provide screening assays (LDH, XTT, Neutral Red and Cleaved Caspase 3) and regulatory assays (USP <87>, ISO 10993-5) to satisfy your needs.

PHOTOMUTAGENICITY AND PHOTOTOXICITY ASSAYS

Phototoxicity is a toxic response from a substance applied to the body which is either elicited or increased after subsequent exposure to light, or that is induced by skin irradiation after systemic administration of a substance.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), has issued draft Guidelines ICH S10 on Photosafety Evaluation of Pharmaceuticals. According to these guidelines, phototoxicity testing may be required for the risk evaluation of compounds seeking market authorization.

Nucro-Technics can perform phototoxicity (OECD 432)  and photogenotoxicity (chromosome aberration and Micronucleus) assays in compliance with Good Laboratory Practices.

We recognize that our clients have particular testing needs; we would be pleased to work with you to customize a protocol that will meet your budget and scientific requirements.

For further information about these services, to receive a quotation, or to schedule a test, please contact NUCRO-TECHNICS.