Genotoxicity Test for Live Biotherapeutic Products

Genotoxicity testing is used to assess the possibility of mutations or chromosomal abnormalities caused by the use of candidate drugs. For the genetic toxicity test of live biotherapeutic products, Creative Biolabs provides a variety of test types according to your product type and data requirements.

What is Genotoxicity?

In genetics, genotoxicity is a term that describes properties related to the ability of a substance to cause damage to genetic material. This can lead to mutations and various types of cancer. Genotoxic agents have two different effects in eukaryotes, depending on the type of cells affected. In somatic cells, genetic damage may lead to malignant tumors (cancer), while in germ cells, hereditary mutations may occur, leading to congenital defects.

According to their functions in organisms, genotoxins can be classified as follows:

• carcinogens: cancer-causing
• mutagens: 
• teratogens: birth defects-causing

Common damages caused by genotoxic agents include DNA single- and double-strand breaks, structural and digital chromosome aberrations, point mutations, and loss of excision repair. If you want to ensure the safety of new live biotherapeutic products, it is important to understand the potential effects of the substance through genotoxicity analysis.

Introduction of Genotoxicity Test

In the early detection phase, genotoxicity tests used to predict potential genetic germ cell damage are the same as those used to predict carcinogenicity, because the endpoint measured in the genotoxicity test is a common precursor to both adverse health outcomes. To thoroughly assess the genotoxicity/mutagenicity potential of a substance, different types of biological changes need to be evaluated.

Genotoxicity Test Provided by Creative Biolabs

At present, Creative Biolabs has many different techniques that can be used to test the genotoxicity of a substance. These tests can be in vivo or in vitro.

In vivo tests:

• Heritable germ cell mutagenicity tests:

include mouse genetic translocation test, mouse specific locus test, and rodent dominant lethal test.

• Germ cell genotoxicity induction test:

to predict the substances that may cause genetic damage, including mammalian sperm cell chromosome aberration test, sperm cell micronucleus test, mammalian oocyte chromosome aberration/aneuploidy test, and testicular unplanned DNA synthesis test.

• Somatic genotoxicity induction test:

to predict substances that may induce genotoxicity of germ cells, including mammalian erythrocyte micronucleus test, mammalian bone marrow chromosome aberration test, liver unscheduled DNA synthesis (UDS), and mouse spot test.

• Comet assay (Single-cell gel electrophoresis)

In vitro tests:

• Methods of mutagenicity test based on bacterial cells:

include bacterial reverse mutation test (Ames test) and Escherichia coli reverse mutation test.

• Methods of mutagenicity test based on mammalian cells:

include mammalian chromosome aberration test and mammalian cell gene mutation test.

• Micronucleus test (MN)

In Creative Biolabs, many of our genotoxicity studies will combine multiple determination methods to establish a complete description of the potential genotoxicity of the live biotherapeutic product to be tested. If you are interested in our services, please contact us for more information.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.