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>>GLP-Compliant Genetic Toxicology Testing Services per FDA / ICH S2(R1)
GLP-Compliant Genetic Toxicology Testing Services per FDA / ICH S2(R1)2019-01-07T11:37:19-05:00

Genetic Toxicology Overview

Nucro-Technics has a full service genetic toxicology department to support the genotoxic potential characterization of your compounds from screening to NDA / IND 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 typically use OECD methods and satisfies the test requirements of the FDA / ICH S2(R1) Guidelines.  this testing can then be used to fulfill the requirements of the FDA, EPA, OECD, EMEA, ISO, Health Canada, and other regulatory bodies worldwide.

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:

FDA / ICH S2(R1) Test CategoryTest Battery 1Test Battery 2
Bacterial Reverse Mutation Test (Ames Assay)1 Assay1 Assay
In Vitro DNA Damage in Mammalian Cells (Example: In Vitro Chromosome Aberration Assay, Mouse Lymphoma Assay, In Vitro Micronucleus Assay)1 AssayNone
In Vivo Test for Genetic Damage (Example: In Vivo Chromosome Aberration Assay, In Vivo Micronucleus Test)1 Assay2 Assays using different organs

Effectively there are two options when it comes to conducting the test battery required to fulfill the FDA / ICH S2(R1) guidances.  In both test batteries an Ames Test is a requirement.  In Test Battery 1, a client would need to complete an additional in vitro test and an in vivo test.  If Test Battery 2 is chosen, 2 in vitro assays using  different organs would be required.  Unless there is a molecule-specific reason to conduct 2 in vivo tests, Nucro-Technics recommends following test Battery 1.

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.

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For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, get in touch.