Abstract
The encapsulation of tissue in semi-permeable membranes is a technology with high potential and in due time several new therapies based on this technology will be tested in clinical trials. Recent, new legislation requires that these investigational medicinal products used in clinical trials Phase I must be produced according to Good Manufacturing Practice (GMP). Consequently, the activities of GMP are expanding to the field of research and researchers might need to change developed protocols in order to meet GMP legislation. This chapters gives an overview of the overall guidelines covering GMP and more specific guidelines dealing with cell based therapies and gene therapy.
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© 2010 Landes Bioscience and Springer Science+Business Media
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van Zanten, J., de Vos, P. (2010). Regulatory Considerations in Application of Encapsulated Cell Therapies. In: Pedraz, J.L., Orive, G. (eds) Therapeutic Applications of Cell Microencapsulation. Advances in Experimental Medicine and Biology, vol 670. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-5786-3_4
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DOI: https://doi.org/10.1007/978-1-4419-5786-3_4
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4419-5785-6
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