Biopredic International NoSpin HepaRG cells, or equal

Procurement Summary

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT) requires Biopredic International NoSpin HepaRG cells, or equal, to conduct research described in NCTR protocols S000904 and E07737.01. The NoSpin HepaRG cells will be used to assess the cytotoxicity and genotoxicity of a total of over 30 small-molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs). Nitrosamines have been known to be carcinogenic in rodent models. Recently, nitrosamines have drawn increased attention by the FDA due to the identification of unacceptable levels of nitrosamines as impurities in several common medicines used for the treatment of hypertension, heartburn, and diabetes. HepaRG cells are human-derived, metabolically competent cells. The DGMT lab has successfully adapted HepaRG cells cultured in both 2D and 3D formats for performing three genotoxicity assays: the comet assay, micronucleus assay, and an error-corrected Next Generation Sequencing mutagenesis assay. Data generated from this cell model are considered relevant for evaluating the health risks caused by human exposure to various potential toxicants and for supporting regulatory decision-making. Specifically, these cells will be used in protocols S000904 and E07737.01 to evaluate the human cancer risks associated with nitrosamine drug impurities of concern to the FDA.

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