Regulatory considerations in application of encapsulated cell therapies.
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.
van Zanten
J
J
Department of PLG/Medical Biology, University Medical Center Groningen, University of Groningen, PO Box 30001, 9700 RB Groningen, the Netherlands. j.van.zanten@med.umcg.nl
de Vos
Paul
P
D017690:Cell Transplantation / Q000295:instrumentation / Q000379:methods; D002986:Clinical Trials as Topic; D004339:Drug Compounding; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods; D015316:Genetic Therapy; D017408:Guidelines as Topic; D006801:Humans; D023822:Tissue Engineering; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence