Accreditation and regulations in cell therapy

Chabannon, C, Caunday-rigot, O, Faucher, C, Slaper-Cortenbach, I, Calmels, B, Lemarie, C, Mahalatchimy, Aurelie, Mcgrath, E and Rial-Sebbag, E (2016) Accreditation and regulations in cell therapy. ISBT Science Series, 11 (Supp 1). pp. 271-276. ISSN 1751-2816

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Advances in stem cell biology and immunology raise hopes for new developments in regenerative medicine as well as cell-based immune intervention, with potential applications in many medical disciplines. Emerging from the medical practices of organ, tissue and cell transplantations over several decades, the development of cellular therapies nowadays enter a new era in which the industry may take cell manufacturing activities away from academic facilities, using complex procedures for cell engineering and large-scale production at centralized facilities. Recent changes in regulations push towards this historical transition; however, a pragmatic analysis of met and unmet clinical needs, as well as of specific procedural and organizational aspects that govern human cell procurement and processing suggest that a significant role will remain for academic facilities in the near future. Taking advantage of the large experience in the field of haematopoietic stem cell transplantation, we here review actual and potential consequences of regulatory changes in these medical practices, with a focus on the unique system for quality management that has been established in Europe and the United States of America to address specific risks associated with these therapeutic procedures.

Item Type: Article
Schools and Departments: School of Global Studies > International Relations
Depositing User: Aurelie Mahalatchimy
Date Deposited: 01 Apr 2016 13:49
Last Modified: 01 Apr 2016 13:49
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