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| Verfasst von: | Cohen-Haguenauer, Odile [VerfasserIn]  |
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| | Creff, N. [VerfasserIn] |
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| | Cruz, P. [VerfasserIn] |
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| | Tunc, C. [VerfasserIn] |
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| | Aïuti, A. [VerfasserIn] |
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| | Baum, C. [VerfasserIn] |
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| | Bosch, F. [VerfasserIn] |
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| | Blomberg, P. [VerfasserIn] |
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| | Cichutek, K. [VerfasserIn] |
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| | Collins, M. [VerfasserIn] |
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| | Danos, O. [VerfasserIn] |
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| | Dehaut, F. [VerfasserIn] |
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| | Federspiel, M. [VerfasserIn] |
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| | Galun, E. [VerfasserIn] |
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| | Garritsen, H. [VerfasserIn] |
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| | Hauser, H. [VerfasserIn] |
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| | Hildebrandt, M. [VerfasserIn] |
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| | Klatzmann, D. [VerfasserIn] |
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| | Merten, O. W. [VerfasserIn] |
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| | Montini, E. [VerfasserIn] |
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| | O'Brien, T. [VerfasserIn] |
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| | Panet, A. [VerfasserIn] |
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| | Rasooly, L. [VerfasserIn] |
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| | Scherman, D. [VerfasserIn] |
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| | Schmidt, Martina [VerfasserIn] |
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| | Schweitzer, M. [VerfasserIn] |
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| | Tiberghien, P. [VerfasserIn] |
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| | Vandendriessche, T. [VerfasserIn] |
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| | Ziehr, H. [VerfasserIn] |
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| | Ylä-Herttuala, S. [VerfasserIn] |
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| | von Kalle, C. [VerfasserIn] |
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| | Gahrton, G. [VerfasserIn] |
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| | Carrondo, M. [VerfasserIn] |
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| Titel: | Relevance of an academic GMP Pan-European vector infra-structure (PEVI) |
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| Verf.angabe: | O. Cohen-Haguenauer, N. Creff, P. Cruz, C. Tunc, A. Aïuti, C. Baum, F. Bosch, P. Blomberg, K. Cichutek, M. Collins, O. Danos, F. Dehaut, M. Federspiel, E. Galun, H. Garritsen, H. Hauser, M. Hildebrandt, D. Klatzmann, O.W. Merten, E. Montini, T. O'Brien, A. Panet, L. Rasooly, D. Scherman, M. Schmidt, M. Schweitzer, P. Tiberghien, T. Vandendriessche, H. Ziehr, S. Ylä-Herttuala, C. von Kalle, G. Gahrton, M. Carrondo |
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| Jahr: | 2010 |
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| Umfang: | 9 S. |
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| Fussnoten: | Gesehen am 10.05.2023 |
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| Titel Quelle: | Enthalten in: Current gene therapy |
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| Ort Quelle: | Hilversum [u.a.] : Bentham Science Publ., 2001 |
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| Jahr Quelle: | 2010 |
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| Band/Heft Quelle: | 10(2010), 6, Seite 414-422 |
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| ISSN Quelle: | 1875-5631 |
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| Abstract: | In the past 5 years, European investigators have played a major role in the development of clinical gene therapy. The provision of substantial funds by some individual member states to construct GMP facilities makes it an opportune time to network available gene therapy GMP facilities at an EU level. The integrated coordination of GMP production facilities and human skills for advanced gene and genetically-modified (GM) cell therapy, can dramatically enhance academic-led "First-in-man" gene therapy trials. Once proof of efficacy is gathered, technology can be transferred to the private sector which will take over further development taking advantage of knowledge and know-how. Complex technical challenges require existing production facilities to adapt to emerging technologies in a coordinated manner. These include a mandatory requirement for the highest quality of production translating gene-transfer technologies with pharmaceutical-grade GMP processes to the clinic. A consensus has emerged on the directions and priorities to adopt, applying to advanced technologies with improved efficacy and safety profiles, in particular AAV, lentivirus-based and oncolytic vectors. Translating cutting-edge research into "First-in-man" trials require that pre-normative research is conducted which aims to develop standard assays, processes and candidate reference materials. This research will help harmonise practices and quality in the production of GMP vector lots and GM-cells. In gathering critical expertise in Europe and establish conditions for interoperability, the PEVI infrastructure will contribute to the demands of the advanced therapy medicinal products* regulation and to both health and quality of life of EU-citizens. |
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| DOI: | doi:10.2174/156652310793797702 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: https://doi.org/10.2174/156652310793797702 |
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| | DOI: https://doi.org/10.2174/156652310793797702 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | Academies and Institutes |
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| | Cell Transplantation |
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| | Clinical Trials as Topic |
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| | Drug Design |
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| | Drug Industry |
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| | Europe |
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| | Genetic Therapy |
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| | Genetic Vectors |
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| | Humans |
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| K10plus-PPN: | 1844978249 |
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| Verknüpfungen: | → Zeitschrift |
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Relevance of an academic GMP Pan-European vector infra-structure (PEVI) / Cohen-Haguenauer, Odile [VerfasserIn]; 2010 (Online-Ressource)
