Cell therapy: cGMP facilities and manufacturing

Giancola, Raffaella and Bonfini, Tiziana and Iacone, Antonio (2012) Cell therapy: cGMP facilities and manufacturing. M.L.T.J. Muscles, Ligaments and Tendons Journal, 2 (3). pp. 243-247. ISSN 2240-4554

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Abstract

Advanced therapies constitute one of the most complex, organizational, and regulatory areas currently approached by clinical researchers in order to explore new therapeutic applications. Basic scientists and clinicians trying to implement cell therapies into clinical practice, may feel overwhelmed by the apparently endless regulatory requirements that apply. However, regulatory agencies have primary responsibility on patient safety and law enforcement are, and should be, their main considerations. Cell- and tissuebased therapies have the potential to treat many conditions, where present conventional treatments are inadequate. The current approach to cell- and tissue-based therapy development requires using good manufacturing production facilities through master and working cell banks. Facilities need to be purpose-designed and accredited by their national medicinal regulatory body and production scientists need to work in close tandem with quality assurances and ethics committees to absolutely ensure the safety of this cellular products

Item Type:	Article
Uncontrolled Keywords:	MSC, manufacturing, tissue engineering
Subjects:	600 Tecnologia - Scienze applicate > 610 Medicina e salute (Classificare qui la tecnologia dei servizi medici) > 616 Malattie (classificare qui la Clinica medica, la medicina basata sull'evidenza, la Medicina interna, la Medicina sperimentale) > 616.7 Malattie del sistema muscoloscheletrico
Depositing User:	Danilo Dezzi
Date Deposited:	16 Apr 2014 16:42
Last Modified:	16 Apr 2014 16:42
URI:	http://eprints.bice.rm.cnr.it/id/eprint/8150

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