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
Pages: 508
Pages to: 513
Issue Date: 2019
Publisher / Ed. Institution: Editio Cantor Verlag
ISSN: 0031-711X
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.
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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