|Publication type:||Contribution to magazine or newspaper|
|Title:||Advanced therapy medicinal products (ATMPs) & GMP : 10 years after|
|Authors:||van den Bos, Christian|
|Published in:||Die Pharmazeutische Industrie : pharmind|
|Publisher / Ed. Institution:||Editio Cantor Verlag|
|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.|
|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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