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Regulatory Considerations in Application of Encapsulated Cell Therapies

  • J. van Zanten
  • Paul de Vos
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 670)

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.

Keywords

Medicinal Product Good Manufacture Practice Investigational Medicinal Product Advance Medicinal Therapy Product Regulatory Consideration 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Landes Bioscience and Springer Science+Business Media 2010

Authors and Affiliations

  • J. van Zanten
    • 1
  • Paul de Vos
    • 1
  1. 1.Department of PLG/Medical Biology, University Medical Center GroningenUniversity of GroningenGroningenthe Netherlands

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