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

Research output: Contribution to JournalReview articleAcademicpeer-review


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
Pages (from-to)259-297
Number of pages39
JournalAdvances in Experimental Medicine and Biology
Publication statusPublished - 28 Sept 2016
Externally publishedYes


  • Cell Differentiation
  • Cell Proliferation
  • Humans
  • In Vitro Techniques
  • Pluripotent Stem Cells
  • Quality Control
  • Toxicity Tests
  • Journal Article
  • Review


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