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- Title
The regulatory landscape for actively personalized cancer immunotherapies.
- Authors
Britten, Cedrik M; Singh-Jasuja, Harpreet; Flamion, Bruno; Hoos, Axel; Huber, Christoph; Kallen, Karl-Josef; Khleif, Samir N; Kreiter, Sebastian; Nielsen, Michaela; Rammensee, Hans-Georg; Sahin, Ugur; Hinz, Thomas; Kalinke, Ulrich
- Abstract
The article focuses on the regulatory challenges associated with the introduction of innovative personalized medicine for treatment of cancer. It informs that addressing the regulatory challenges requires a differentiated look at quality, preclinical and clinical aspects. It adds that regulatory principles that are applied to the manufacture and quality control of actively personalized vaccines (APVACs) are similar to those relevant for autologous cell therapies.
- Subjects
INDIVIDUALIZED medicine; CANCER treatment; GOVERNMENT regulation; INDIVIDUALIZED instruction; STANDARDIZATION
- Publication
Nature Biotechnology, 2013, Vol 31, Issue 10, p880
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt.2708