Development and implementation of large-scale quality control for the European bank for induced Pluripotent Stem Cells.

Abstract

The European Bank for induced Pluripotent Stem Cells (EBiSC) has collected iPSC lines associated with genetic diseases and healthy controls from across Europe and made these available for research use to international academic and commercial users. Ensuring availability of consistently high quality iPSCs at scale and from various sources requires quality systems which are flexible yet robust, maximising the utilisation of available resources. Here, we outline the establishment and implementation of a quality control regime suitable for a large-scale operational setting. Strict release testing ensures the safety and integrity of distributed iPSC lines, whilst informational testing allows publication of full characterisation and assessment of iPSC lines. Quality control screening is underpinned by a 'fit-for-purpose' Quality Management System giving full traceability and supporting continuous scientific and process development. Evaluation and qualification of key assays and techniques ensures that assay sensitivities and limits of detection are acceptable. Use of rapid testing techniques in place of more 'traditional' assays allows EBiSC to respond quickly to user demand, generating fully qualified iPSC line banks in a labour-saving and cost-efficient manner.