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The International Stem Cell Banking Initiative(ISCBI) was started in 2007 to bring together the leading stem cell banks distributing human pluripotent stem cell (hPSC) lines for research and development, to discuss best practice across a range of issues from donor consent to delivery of cells for use in research, diagnostics and cell-based medicines. ISCBI holds workshops around the world and on-line and regularly publishes summaries of discussions and consensus amongst experts in stem cell biology, biobanking technology, regulation and policy making. To date, experts from more than 28 countries have contributed to ISCBI activities which are frequently run in collaboration with other stem cell organisations and has co-ordinated closely with the International Stem Cell Initiative and the hPSCreg European Commission funded database of hPSC lines and clincal trials., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

The Global Alliance for iPSC Therapies (GAiT) is a new initiative to support the implementation and clinical application of therapies derived from pluripotent stem cells to the benefit of patients globally. GAiT's mission is to serve as a central, international resource for those organisations developing therapies from clinical-grade induced pluripotent stem cells, and to support the expansion of this nascent field. With the support of its international partners, GAiT already has an early position on manufacturing, regulatory and quality standards. This article details GAiT's development, its mission and structure, as well as how, and by whom, it is funded. The article ends with brief overview of current and upcoming activities., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

The Chinese National Stem Cell Resource Center was first established in 2007 and has progressed to produce and prepare stocks of more than 400 human embryonic stem cell lines. Its facilities are accredited to international standards and it has accreditation as a supplier of cells for research and therapy. The NSCRC also has an active program of translational research and strong collaborations with the Institute of Zoology and the Academy for Stem Cells and Regeneration of the Chinese Academy of Sciences. Its translational research extends to early stage clinical studies and it also has a strong training and public education program., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020. Published by Elsevier B.V.)

The value of human pluripotent stem cells (hPSC) in regenerative medicine has yet to reach its full potential. The road from basic research tool to clinically validated PSC-derived cell therapy products is a long and winding one, leading researchers, clinicians, industry and regulators alike into undiscovered territory. All stakeholders must work together to ensure the development of safe and effective cell therapies. Similarly, utilization of hPSC in meaningful and controlled disease modeling and drug screening applications requires information on the quality and suitability of the applied cell lines. Central to these common goals is the complete documentation of hPSC data, including the ethical provenance of the source material, the hPSC line derivation, culture conditions and genetic constitution of the lines. Data surrounding hPSC is scattered amongst diverse sources, including publications, supplemental data, researcher lab books, accredited lab reports, certificates of analyses and public data repositories. Not all of these data sources are publicly accessible nor associated with metadata nor stored in a standard manner, such that data can be easily found and retrieved. The Human Pluripotent Stem Cell Registry (hPSCreg; https://hpscreg.eu/) was started in 2007 to impart provenance and transparency towards hPSC research by registering and collecting standard properties of hPSC lines. In this chapter, we present a short primer on the history of stem cell-based products, summarize the ethical and regulatory issues introduced in the course of working with hPSC-derived products and their associated data, and finally present the Human Pluripotent Stem Cell Registry as a valuable resource for all stakeholders in therapies and disease modeling based on hPSC-derived cells., Competing Interests: Declaration of Competing Interest The authors declared that there is no conflict of interest., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

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., (Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.)