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in vitro Screening for Drug-Induced Hepatotoxicity Assay Kit
Product Description and Product Data
The principal application of this assay is to rapidly screen test compounds to identify those that induce acute liver cell toxicity.
This kit includes two aliquots of cryopreserved Luminescent Reporter Hepatocytes (upcyte®), donor 10-13, isolated from an adult Caucasian female, that have been further modified to constitutively express the luciferase enzyme. In addition to two aliquots of the reporter hepatocytes, the kit provides two cell culture-ready assay plates, optimized Cell Culture Media (CCM) for use in all steps of the assay procedure (cell thawing, seeding, and preparation of the treatment media), luciferase detection reagent, and a reference compound that provides a positive control for hepatotoxicity.
The reagents and materials provided in this assay kit are formatted to allow the user to choose between two alternative assay setups. In one scenario 48 culture wells may be setup at two different times. In the other assay scenario 96 culture wells may be setup at one time.
Features
Clear, Reproducible Results
- All-Inclusive Assay Systems
- Exceptional Cell Viability Post-Thaw
- Consistent Results Lot to Lot
Product Specifications
| Species | Human | ||
| Kit Components |
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| Shelf Life | 6 months | ||
| Shipping Requirements | Dry Ice | ||
| Storage temperature | -80C |
Data
Target Background
Xenobiotic-induced liver injury is a major cause of human morbidity and mortality. A key reason for this problem is our inability to predict hepatotoxicity at the preclinical stage using currently available model systems. Such models include in vivo animal models and in vitro models based on human-derived liver cells or transformed cell systems. Species differences in xenobiotic disposition and mechanisms of cytotoxicity can make whole animal studies unreliable for extrapolation to human. In addition, whole animal models are costly and of low throughput. Therefore, it is essential to develop in vitro models that are more predictive of hepatotoxicity, particularly those that are based on human or “humanized” component cells.
There are two major limitations to the use of human liver cells or their derivatives. First, there are currently limited sources of fresh human hepatocytes worldwide and, when available, they often suffer from low viability and high batch-to-batch variability. Second, the freezing process used to preserve primary hepatocytes and the transformation process needed to make stable and proliferating cell lines results in changes in cell differentiation, proliferation, and metabolic processes.
INDIGO’s in vitro toxicology platform was developed to meet the increasing demand for more predictive models for liver toxicity due to the fact that hepatotoxicity remains a major reason for drug withdrawal from pharmaceutical development and clinical use. Consequently, the use of hepatocytes for the early identification of drug candidates that induce acute hepatotoxicity provides a powerful predictive tool that can inform drug development decisions.
Application of this platform is to screen chemicals for induction and activity of hepatic drug metabolizing enzymes (DME). which have been linked to Non-Alcoholic Fatty Liver Disease, Steatosis, Cholestasis and other conditions.
The platform now utilizes upcyte® human liver cells to assess chemical and drug-induced toxicity.
Product Documentation
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