| GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers. | |
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MedLine Citation:
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PMID: 21054243 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facility's in-ability to meet the demands. In this chapter we aimed to outline the current issues with regards to the European Union Directives (EUD) and the proposal for Advanced Therapies, which are of importance to cellular and gene therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for cell and gene therapy products are and what is considered necessary to comply with the regulations in Europe. |
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Authors:
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Evren Alici; Pontus Blomberg |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Current gene therapy Volume: 10 ISSN: 1875-5631 ISO Abbreviation: Curr Gene Ther Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-12-23 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101125446 Medline TA: Curr Gene Ther Country: Netherlands |
Other Details:
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Languages: eng Pagination: 508-15 Citation Subset: IM |
Affiliation:
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Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. Evren.Alici@ki.se |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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