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upcyte® Hepatocyte in vitro MN Genotox Assay

The use of the current in vitro micronuclei (MN) test leads to a substantial number of false positives which can no longer be followed-up with an in vivo test. Recent data suggest that the species of a cell type is crucial in detecting MN formation.

Cells that perform reliably in the in vitro MN assay should have Phase I and II enzymes comparable to primary human hepatocytes. The enzymes are needed to reflect the bioactivation or detoxification of compounds that would normally occur in vivo. Therefore, the selection of the cell type for MN tests is crucial for the outcome.
As upcyte® Hepatocytes fulfill the criteria of Phase I and II enzyme activity comparable to primary hepatocytes and are proliferating cells, they are a perfect selection for MN tests. These cells are able to correctly identifiy genotoxins as positive and “false positive” and negative compounds as negative (Table 1).

The upcyte® Hepatocyte Genotoxicity Assay requires 1 vial of cryopreserved upcyte® Hepatocytes (1 million cells), Hepatocyte Thawing Medium and Hepatocyte Culture Medium plus supplement E.

With a potential 2000+ vials from a single donor, data from different studies can be compared using the same donor.

A good predictivity of this during screening phases can exclude compounds at an early stage, so that toxic compounds do not reach animal testing stages.

Please note: these cells are already at a later state in proliferation terms and are “ready-to.use”. Further expansion will lead to the cells expressing senescence genes and the response to genotoxic compounds is lost. If you would like to grow your own working cell bank, we also offer cryopreserved upcyte® Hepatocytes at the master cell bank stage under a license.

For each product a protocol for use and a certificate of analysis will be delivered. All cells have been tested for the absence of CMV, HIV, Hepatitis B and C and microbial contaminants (fungi, bacteria and mycoplasma). upcyte® cells are genetically modified cells (GMO, genetically modified organism) classified as risk group 1 and have to be handled in a genetic engineering facility carrying out genetic engineering work at Security Level 1 (e.g. S1 lab). upcyte® Hepatocytes and upcyte® Endothelial Cells are officially classified as risk group 1 organisms by the German Federal Office of Consumer Protection and Food Safety (BVL) and the Central Committee on Biological Safety (ZKBS). For further information please use the following link and enter “upcyte” in the search boxlink.

PFU No. 10: upcyte® Hepatocytes Genotoxicitypdf

Table 1. Outcome of the testing of true positive, true negative and false positive chemicals



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