O'Shea Orla, Steeg Rachel, Chapman Charlotte, Mackintosh Peter, Stacey Glyn N
UK Stem Cell Bank, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom.
Censo Biotechnologies, Roslin Innovation Centre, Easter Bush Campus, Roslin EH25 9RG, United Kingdom; Technology and Innovation Centre, Fraunhofer UK Research Ltd, 99 George Street, Glasgow G1 1RD, United Kingdom.
Stem Cell Res. 2020 May;45:101773. doi: 10.1016/j.scr.2020.101773. Epub 2020 Mar 20.
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.
欧洲诱导多能干细胞库（EBiSC）从欧洲各地收集了与遗传疾病相关的诱导多能干细胞系（iPSC）和健康对照样本，并将其提供给国际学术和商业用户用于研究。要确保大规模且从各种来源持续获得高质量的诱导多能干细胞，需要具备灵活且强大的质量体系，以最大限度地利用现有资源。在此，我们概述了适合大规模运营环境的质量控制制度的建立与实施。严格的放行测试可确保分发的诱导多能干细胞系的安全性和完整性，而信息测试则允许发布诱导多能干细胞系的完整特征描述和评估结果。质量控制筛选以“适用目的”的质量管理体系为支撑，该体系具有完全可追溯性，并支持持续的科学和流程开发。对关键检测方法和技术的评估与鉴定可确保检测灵敏度和检测限是可接受的。使用快速检测技术替代更为“传统”的检测方法，使欧洲诱导多能干细胞库能够快速响应用户需求，以节省人力和成本效益高的方式生成完全合格的诱导多能干细胞系库。
