Title: Standardisation of Pluripotent Stem Cell Cultures for Toxicity Testing
Publisher: Coach Consortium 2012
Publication Year: 2012
JRC N°: JRC69646
ISBN: 978-2-9539634-1-0
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC69646
Type: Articles in periodicals and books
Abstract: Pluripotent stem cell (PSC) lines offer a unique opportunity to derive various human cell types which can be exploited for a more efficient selection of drug candidates as well as for mechanistically oriented safety evaluations of chemicals. The two major types of PSC cultures that are currently most promising for toxicological applications are human embryonic stem cell (hESC) lines and human induced pluripotent stem cell (hiPSC) lines. However, technical challenges such as their maintenance as well as the differentiation efficiency and the upscaling of relevant cell types to derive significant number of cells for toxicity testing have to be overcome before the cells will be ready for routing applications. Progress has been made for culturing neural cell types as well as cardiomyocytes, whereas the generation of metabolically competent hepatocytes still requires substantial time and efforts. In any case, the demonstration of the reliability and relevance of any toxicity test is mandatory if the tests should be used for regulatory purposes. The peculiar nature of PSCs requires the implementation of additional quality controls in order to reduce intra- and inter-laboratory variability of toxicity tests but also to define genotypic, phenotypic and functional characteristics of the target cells under investigation ensuring that the differentiated cell culture is “fit for purpose” and can provide the answer for a particular toxicological question. Therefore, standardisation of undifferentiated cell culture methods as well as a close monitoring of the differentiation process will be crucial for a successful stem cell based toxicity testing. One of our main objectives in the SCR&Tox project is the development of quality control (QC) standards that can be applied in routine PSC-based toxicity testing.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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