Title: Chapter 11; Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing
Authors: STACEY GlynCOECKE SandraPRICE AnnaHAUPT SimoneHEALY LynINGELMAN-SUNDBERG MagnusJAHNKE Heinz-GeorgJENNINGS PaulKIDD DarrenLEMAITRE GillesLOUISSE JochemPINSET ChristianROBITSKI AndreaWILMES AnjaMYATT Glenn
Publisher: Springer
Publication Year: 2016
JRC N°: JRC103062
ISBN: 978-3-319-33824-8
ISSN: 0065-2598
URI: http://www.springer.com/series/5584
http://publications.jrc.ec.europa.eu/repository/handle/JRC103062
DOI: 10.1007/978-3-319-33826-2
Type: Articles in periodicals and books
Abstract: Quality control of cell cultures used in new in vitro toxicology assays is crucial to the provision of reliable, reproducible and accurate toxicity data on new drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to be acceptable for regulatory, laboratory safety and commercial purposes. Also addressed is the development of hPSC-based assays for the tissue and cell types of greatest interest in drug toxicology. The chapter draws on a range of expert opinion within the European Commission/Cosmetics Europe-funded alternative testing cluster SEURAT-1 and consensus from international groups delivering this guidance such as the International Stem Cell Banking Initiative. Accordingly, the chapter summarizes the most up-date best practices in the use and quality control of human Pluripotent Stem Cell lines in the development of in vitro toxicity assays from leading experts in the field.
JRC Directorate:Health, Consumers and Reference Materials

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