Abstract

QC and Assay Development for Product Safety Testing Using Pluripotent Stem Cell Based Systems

Glyn Stacey, Head/Director, The National Institute For Biological Standards And Control

The development of assays for product safety testing based on human pluripotent stem cell lines requires careful evaluation of the starting cell line and qualification of the protocol to deliver the final cells for testing. The selection of the starting material (the cell line) and raw materials for the assay is vital as any error at this stage can have dramatic effects on the suitability of the final assays and their ability to be used in a commercial setting. These issues have been addressed in development of Good Cell Culture Practice (Coecke et el., 2005) which identifies six principles that are fundamental to assuring the quality of general cell culture practice. A further development of this best practice guidance is being led by the Centre for Alternatives to Animal Testing (http://caat.jhsph.edu/about/index.html) and will incorporate guidance on pluripotent stem cell culture and 3D culture systems (Pamies et al., 2016). The presentation will also consider quality control and characterisation of stem cell based assays from the experiences of the EC/Colipa funded Seurat-1 project (www.seurat-1.eu/ ; Stacey et al, 2016).