Abstract
The production of clinical batches of cells for cell therapy poses a series of challenges that are related to the high degree of biological variability typical of the living organisms. Since a full characterization of every property of a cellular product is very difficult, it is mandatory to extensively characterize the process in order to generate a safe and effective product in a reproducible way. Here we describe a procedure for the production and quality control analysis of clinical batches of bone marrow-derived mesenchymal stem cells.
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References
Regulation (EC) No 1394/2007 of the european parliament and of the council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
5.2.1 European Pharmacopoeia (Ph. Eur.): Supplement 6.3 (official in January 2009), Sterility (reference 01/2009:20601)
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Romagnoli, L. et al. (2012). cGMP-Compliant Isolation, Expansion and Quality Testing of Human Bone Marrow-Derived Mesenchymal Stem Cells. In: Jenkins, N., Barron, N., Alves, P. (eds) Proceedings of the 21st Annual Meeting of the European Society for Animal Cell Technology (ESACT), Dublin, Ireland, June 7-10, 2009. ESACT Proceedings, vol 5. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-0884-6_31
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DOI: https://doi.org/10.1007/978-94-007-0884-6_31
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