Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.
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.
UK Stem Cell Bank, Advanced Therapies Division, NIBSC-MHRA, London, UK. glyn.stacey@nibsc.org.|SEURAT-1 Stem Cell Group, Paris, France. glyn.stacey@nibsc.org.
Glyn N
GN
Stacey
SEURAT-1 Stem Cell Group, Paris, France.|European Commission, Joint Research Centre (JRC), Ispra, Italy.
Sandra
S
Coecke
SEURAT-1 Stem Cell Group, Paris, France.|European Commission, Joint Research Centre (JRC), Ispra, Italy.
Anna-Bal
AB
Price
SEURAT-1 Stem Cell Group, Paris, France.|Haematopoietic Stem Cell Laboratory, The Francis Crick Institute, 44 Lincoln's Inn Fields, London, WC2A 3LY, UK.
Lyn
L
Healy
SEURAT-1 Stem Cell Group, Paris, France.|Division of Physiology, Medical University of Innsbruck, Innsbruck, Austria.
Paul
P
Jennings
SEURAT-1 Stem Cell Group, Paris, France.|Division of Physiology, Medical University of Innsbruck, Innsbruck, Austria.
Anja
A
Wilmes
SEURAT-1 Stem Cell Group, Paris, France.|I-Stem, INSERM/UEVE U861, Evry, France.
Christian
C
Pinset
SEURAT-1 Stem Cell Group, Paris, France.|Karolinska Institutet, Solna, Sweden.
Magnus
M
Ingelman-Sundberg
SEURAT-1 Stem Cell Group, Paris, France.|Wageningen University and Research Centre, Wageningen, Netherlands.
Jochem
J
Louisse
SEURAT-1 Stem Cell Group, Paris, France.|Life and Brain, Bonn, Germany.
Simone
S
Haupt
SEURAT-1 Stem Cell Group, Paris, France.|Covance Laboratories Limited, Harrogate, UK.
Darren
D
Kidd
SEURAT-1 Stem Cell Group, Paris, France.|University of Leipzig, Leipzig, Germany.
Andrea
A
Robitski
SEURAT-1 Stem Cell Group, Paris, France.|University of Leipzig, Leipzig, Germany.
Heinz-Georg
HG
Jahnke
SEURAT-1 Stem Cell Group, Paris, France.|I-Stem, INSERM/UEVE U861, Evry, France.
Gilles
G
Lemaitre
SEURAT-1 Stem Cell Group, Paris, France.|Leadscope, Columbus, OH, USA.
Glenn
G
Myatt
D002454:Cell Differentiation; D049109:Cell Proliferation; D006801:Humans; D066298:In Vitro Techniques / Q000592:standards*; D039904:Pluripotent Stem Cells / Q000166:cytology*; D011786:Quality Control; D018675:Toxicity Tests / Q000379:methods*
Quality control; Stem cell characterisation; Stem cell differentiation; Toxicology