Title: Standardisation of Pluripotent Stem Cell Cultures for Toxicity Testing
Authors: PISTOLLATO FRANCESCABREMER SusanneHEALY LynYOUNG LesleySTACEY Glyn
Citation: EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY vol. 8 no. 2 p. 239-257
Publisher: INFORMA HEALTHCARE
Publication Year: 2012
JRC N°: JRC65647
ISSN: 1742-5255
URI: http://informahealthcare.com/eprint/cF389bK7yqUQi2EBzI3X/full
http://publications.jrc.ec.europa.eu/repository/handle/JRC65647
DOI: 10.1517/17425255.2012.639763
Type: Articles in Journals
Abstract: Introduction: Pluripotent stem cell (PSC) lines offer a unique opportunity to derive various human cell types which can be exploited for human safety assessments in vitro and as such contribute to modern mechanistically oriented toxicity testing. Areas covered: The two major types of pluripotent stem cell cultures that are currently most promising for toxicological applications are human embryonic stem cell lines and human induced pluripotent stem cell lines. These cell types will improve current safety evaluations of chemicals and will allow a more efficient selection of drug candidates. However, one important issue in the use of PSCs is that the maintenance as well as the differentiation efficiency is technically challenging. Expert opinion: The demonstration of the reliability and relevance of in vitro toxicity tests for a given purpose is mandatory for their use in regulatory toxicity testing. Given the peculiar nature of PSCs, a high level of standardisation of undifferentiated cell cultures as well as of the differentiation process is required in order to ensure the establishment of robust test systems. It is therefore of pivotal importance to define and internationally agree on crucial parameters to judge the quality of the cellular models before enrolling them for toxicity testing.
JRC Institute:Institute for Health and Consumer Protection

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