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.
Subject(s)
Induced Pluripotent Stem Cells , Europe , Quality ControlABSTRACT
Alzheimer's disease (AD) is the most frequent neurodegenerative disease amongst the elderly. The SNPs rs429358 and rs7412 in the APOE gene are the most common risk factor for sporadic AD, and there are three different alleles commonly referred to as APOE-ε2, APOE-ε3 and APOE-ε4. Induced pluripotent stem cells (iPSCs) hold great promise to model AD as such cells can be differentiated in vitro to the required cell type. Here we report the use of CRISPR/Cas9 technology employed on iPSCs from a healthy individual with an APOE-ε3/ε4 genotype to obtain isogenic APOE-ε2/ε2, APOE-ε3/ε3, APOE-ε4/ε4 lines as well as an APOE-knock-out line.
