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. To meet these needs, EBiSC has established a range of quality control tests and acceptance criteria which are flexible but ensure high quality.
Strict release assays such as mycoplasma, sterility and cell line identity ensures the safety and integrity of distributed iPSC lines. Informational characterisation of marker expression, differentiation potential and gneomic stability allows assessment of the cell line phenotype as a whole. All data is shared to users to inform cell line purchase. Additionally, 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.
During the establishment of EBiSC, a number of challenges and experiences led to refinement of the QC regime employed. Here EBiSC discusses the various developments and key learning points including frequent test failures which led to the current EBiSC QC and characterisation regime and its ongoing programme of development under the second project phase, EBiSC2.
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Written by Rachel Steeg, May 2021
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