1. Good Manufacturing Practices Production of Mesenchymal Stem/Stromal Cells
- Author
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Philippe Bourin, Luc Sensebé, Karin Tarte, Etablissement Français du Sang Centre-Atlantique, Etablissement Français du Sang Pyrénées-Méditerranée, Microenvironnement et cancer (MiCa), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
- Subjects
Quality Control ,Stromal cell ,MESH: Clinical Trials as Topic ,Mesenchyme ,MESH: Quality Control ,Cell Culture Techniques ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Bone Marrow Cells ,Biology ,Cell therapy ,MESH: Bioreactors ,03 medical and health sciences ,Bioreactors ,0302 clinical medicine ,Immune system ,Genetics ,medicine ,Humans ,Good manufacturing practice ,Molecular Biology ,MESH: Hematopoietic Stem Cell Transplantation ,030304 developmental biology ,MESH: Cell Culture Techniques ,Clinical Trials as Topic ,0303 health sciences ,MESH: Humans ,MESH: Bone Marrow Cells ,Mesenchymal stem cell ,Hematopoietic Stem Cell Transplantation ,Mesenchymal Stem Cells ,3. Good health ,Cell biology ,MESH: Mesenchymal Stem Cells ,medicine.anatomical_structure ,Cell culture ,030220 oncology & carcinogenesis ,Immunology ,Molecular Medicine ,MESH: Stromal Cells ,Stromal Cells ,Stem cell - Abstract
International audience; Because of their multi/pluripotency and immunosuppressive properties mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs has led to production processes that need to be in accordance with Good Manufacturing Practice (GMP). In cellular therapy, safety remains one of the main concerns and refers to donor validation, choice of starting material, processes, and the controls used, not only at the batch release level but also during the development of processes. The culture processes should be reproducible, robust, and efficient. Moreover, they should be adapted to closed systems that are easy to use. Implementing controls during the manufacturing of clinical-grade MSCs is essential. The controls should ensure microbiological safety but also avoid potential side effects linked to genomic instability driving transformation and senescence or decrease of cell functions (immunoregulation, differentiation potential). In this rapidly evolving field, a new approach to controls is needed.
- Published
- 2011