| Publication type: | Contribution to magazine or newspaper |
| Title: | Advanced therapy medicinal products (ATMPs) & GMP : 10 years after |
| Authors: | van den Bos, Christian Jossen, Valentin Eibl, Dieter Eibl-Schindler, Regine |
| et. al: | No |
| Published in: | Die Pharmazeutische Industrie : pharmind |
| Volume(Issue): | 81 |
| Issue: | 4 |
| Page(s): | 508 |
| Pages to: | 513 |
| Issue Date: | 2019 |
| Publisher / Ed. Institution: | Editio Cantor Verlag |
| ISSN: | 0031-711X 1616-7074 |
| Language: | English |
| Subject (DDC): | 615: Pharmacology and therapeutics |
| Abstract: | We review the GMP/regulatory experience with advanced therapy medicinal products (ATMPs) approximately 10 years after EC regulation 1394/2007, aka the ATMP regulation applied. Particularly, we discuss practical issues which have arisen during this period and which pertain to quantitative aspects of specifications of such products - both allogenic and autologous - and how these perceived hurdles may help in identifying truly useful products. We further review the impact the ATMP-GMP specific guideline might have and how it reflects the experience gathered. Finally, we shed light on combinations of small molecule drugs and ATMPs; we provide an example of the efficacy of such combination products as well as an outlook concerning their classifications. |
| URI: | https://digitalcollection.zhaw.ch/handle/11475/19663 |
| Fulltext version: | Published version |
| License (according to publishing contract): | Licence according to publishing contract |
| Departement: | Life Sciences and Facility Management |
| Organisational Unit: | Institute of Chemistry and Biotechnology (ICBT) |
| Appears in collections: | Publikationen Life Sciences und Facility Management |
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van den Bos, C., Jossen, V., Eibl, D., & Eibl-Schindler, R. (2019). Advanced therapy medicinal products (ATMPs) & GMP : 10 years after. Die Pharmazeutische Industrie : Pharmind, 81(4), 508–513.
van den Bos, C. et al. (2019) ‘Advanced therapy medicinal products (ATMPs) & GMP : 10 years after’, Die Pharmazeutische Industrie : pharmind, 81(4), pp. 508–513.
C. van den Bos, V. Jossen, D. Eibl, and R. Eibl-Schindler, “Advanced therapy medicinal products (ATMPs) & GMP : 10 years after,” Die Pharmazeutische Industrie : pharmind, vol. 81, no. 4, pp. 508–513, 2019.
VAN DEN BOS, Christian, Valentin JOSSEN, Dieter EIBL und Regine EIBL-SCHINDLER, 2019. Advanced therapy medicinal products (ATMPs) & GMP : 10 years after. Die Pharmazeutische Industrie : pharmind. 2019. Bd. 81, Nr. 4, S. 508–513
van den Bos, Christian, Valentin Jossen, Dieter Eibl, and Regine Eibl-Schindler. 2019. “Advanced Therapy Medicinal Products (ATMPs) & GMP : 10 Years After.” Die Pharmazeutische Industrie : Pharmind 81 (4): 508–13.
van den Bos, Christian, et al. “Advanced Therapy Medicinal Products (ATMPs) & GMP : 10 Years After.” Die Pharmazeutische Industrie : Pharmind, vol. 81, no. 4, 2019, pp. 508–13.
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