Abstract
Stem cell banks are increasingly seen as an essential resource of biological materials for both basic and translational research. As cell-based therapies begin to progress through Phase III clinical trials, there is an increasing need for the development of comprehensive cell banking strategies. There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex vivo. Stem cell banks provide access to quality-controlled and ethically sourced stem cell lines from different origins and of varying grades. Consequently, stem cell banks are destined to constitute a pillar of the bioeconomy in many countries. Generally, the approaches adopted by tissue banking can be the starting point for cell banking too. Commercial viability is possible only if you have a cost-effective comprehensive, end-to-end cell banking mode that includes proper collection, manufacturing and release criteria, cryopreservation and storage of cells, shipping, delivery, and logistics management of the final cell-based product. By developing an understanding of industry standards and best practices in comparable areas, one can reduce research costs, improve efficiencies, create revenue streams, decrease time to discovery, and increase the likelihood of establishment of cell banks for regular use. This chapter will narrate the various components of cell banking that will eventually help autologous and allogeneic cell-based regenerative products and processes. The focus will be on mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSC) as they are most widely used cell type in clinical development.
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Harel A. Cryopreservation and cell banking for autologous mesenchymal stem cell-based therapies. Cell Tissue Transplant Ther. 2013;5:1–7. http://www.la-press.com/cryopreservation-and-cell-banking-for-autologous-mesenchymal-stem-cell-article-a3541. Accessed 26 Nov 2013.
Cooper K, Viswanathan C. Establishment of a mesenchymal stem cell bank. Stem Cells Int. 2011;2011:905621.
Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8:315–7.
Thirumala S, Goebel WS, Woods EJ. Clinical grade adult stem cell banking. Organogenesis. 2009;5(3):143–54.
Coopman K. Large scale compatible methods for the preservation of human embryonic stem cells: current perspective. Biotechnol Prog. 2011;27:1511–21.
Viswanathan C, Kabra P. Umbilical cord blood—progress, process and promise. Frozen life—manual of cryobiology for assisted reproduction and stem cells. Jaypee Publication; 2009. p. 400–16.
Viswanathan C. Cord blood banking: public and private. Hematol Today. 2012;589–98.
United Kingdom Stem Cell Initiative (UKSCI). UK Stem Cell Initiative (UKSCI)—report and recommendations. 271735/UK. London: DH Publications; 2005.
U.S. Food and Drug Administration (FDA). Current good tissue practice (cGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Guidance for industry. Center for Biologics Evaluation and Research. FDA/OCOD. HFM-40. Rockville, MD; 2009.
American Association of Blood Banks. FACT, ISCT guidelines.
U.S. Food and Drug Administration (FDA). Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Guidance for industry. Small entity compliance guide. FDA/HFM-40. Center for Biologics Evaluation and Research. Rockville, MD; 2007.
U.S. Food and Drug Administration (FDA). Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments. Part IV. 21 CFR Parts 16, 1270, 1271. Washington, DC: Federal Register; 2004.
Food and Drug Administration. Draft document concerning the regulation of placental/umbilical cord blood stem cell products intended for transplantation or further manufacture into injectable products. Fed Regist. 1996;61:7087–8.
Harvath L. Food and Drug Administration and a proposed approach to regulation of hematopoietic stem/progenitor cell products for therapeutic use. Transfus Med Rev. 1999;14(2):104–11.
NETCORD, FACT, international standards for cord blood processing, testing, banking, selection and release. 3rd ed. 2006.
Indian Council of Medical Research—Department of Biotechnology (ICMR-DBT). Guidelines for stem cell research and therapy; 2007.
Acknowledgment
The authors acknowledge Reliance Life Sciences Pvt. Ltd. (www.rellife.com), for providing the infrastructure and financial support to work on this project.
Conflict of Interest: This is to inform that I am a current employee of Reliance Life Sciences Pvt. Ltd. and neither I nor the company have a financial gain from this article.
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Viswanathan, C., Shetty, P. (2014). Establishment of Mesenchymal Stem Cell Banks in India. In: Ilic, D. (eds) Stem Cell Banking. Stem Cell Biology and Regenerative Medicine. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-0585-0_11
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DOI: https://doi.org/10.1007/978-1-4939-0585-0_11
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