Ensuring the quality of stem cell-derived in vitro models for toxicity testing

Glyn N. Stacey*, Sandra Coecke, Anna Bal Price, Lyn Healy, Paul Jennings, Anja Wilmes, Christian Pinset, Magnus Ingelman-Sundberg, Jochem Louisse, Simone Haupt, Darren Kidd, Andrea Robitski, Heinz Georg Jahnke, Gilles Lemaitre, Glenn Myatt

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapterAcademicpeer-review

9 Citations (Scopus)


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.

Original languageEnglish
Title of host publicationValidation of Alternative Methods for Toxicity Testing
EditorsC. Eskes, M. Whelan
Place of PublicationCham
Number of pages39
ISBN (Electronic)9783319338262
ISBN (Print)9783319338248
Publication statusPublished - 27 Sept 2016

Publication series

NameAdvances in Experimental Medicine and Biology
ISSN (Print)0065-2598
ISSN (Electronic)2214-8019


  • Quality control
  • Stem cell characterisation
  • Stem cell differentiation
  • Toxicology


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