Regulatory Considerations in Application of Encapsulated Cell Therapies

J. van Zanten*, Paul de Vos

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademic

1 Citaat (Scopus)

Samenvatting

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.

Originele taal-2English
TitelTHERAPEUTIC APPLICATIONS OF CELL MICROENCAPSULATION
RedacteurenJL Pedraz, G Orive
Plaats van productieBERLIN
UitgeverijSpringer
Pagina's31-37
Aantal pagina's7
ISBN van geprinte versie978-1-4419-5785-6
StatusPublished - 2010

Publicatie series

NaamAdvances in Experimental Medicine and Biology
UitgeverijSPRINGER-VERLAG BERLIN
Volume670
ISSN van geprinte versie0065-2598

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