Pearce, Kim F. and Hildebrandt, Martin and Greinix, Hildegard and Scheding, Stefan and Koehl, Ulrike and Worel, Nina and Apperley, Jane and Edinger, Matthias and Hauser, Andrea and Mischak-Weissinger, Eva and Dickinson, Anne M. and Lowdell, Mark W. (2014) Regulation of advanced therapy medicinal products in Europe and the role of academia. CYTOTHERAPY, 16 (3). pp. 289-297. ISSN 1465-3249, 1477-2566
Full text not available from this repository. (Request a copy)Abstract
Background aims. Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients. Academic good manufacturing practice (GMP) centers are major contributors in the development of ATMPs and this study assessed the impact of regulations on them. Methods. European academic and non-industrial facilities (n = 747) were contacted, and a representative sample of 50 replied to a detailed questionnaire. Experienced centres were further selected in every Member State (MS) for semi-structured interviews. Indicators of ATMP production and development success were statistically assessed, and opinions about directive implementation were documented. Results. Facilities experienced in manufacturing cell therapy transplant products are the most successful in developing ATMPs. New centres lacking this background struggle to enter the field, and there remains a shortage of facilities in academia participating in translational research. This is compounded by heterogeneous implementation of the regulations across MS. Conclusions. GMP facilities successfully developing ATMPs are present in all MS. However, the implementation of regulations is heterogeneous between MS, with substantial differences in the definition of ATMPs and in the approved manufacturing environment. The cost of GMP compliance is underestimated by research funding bodies. This is detrimental to development of new ATMPs and commercialization of any that are successful in early clinical trials. Academic GMP practitioners should strengthen their political visibility and contribute to the development of functional and effective European Union legislation in this field.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | TRIAL; advanced therapy medicinal products; European Union; good manufacturing practice; manufacturing; regulation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Petra Gürster |
| Date Deposited: | 22 Jul 2020 08:16 |
| Last Modified: | 22 Jul 2020 08:16 |
| URI: | https://pred.uni-regensburg.de/id/eprint/10607 |
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