Background: The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and
tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:13330 |
| Date | January 2015 |
| Creators | Zscharnack, Matthias, Krause, Christoph, Aust, Gabriela, Thümmler, Christian, Peinemann, Frank, Keller, Thomas, Smink, Jeske J., Holland, Heidrun, Somerson, Jeremy S., Knauer, Jens, Schulz, Ronny M., Lehmann, Jörg |
| Contributors | Universität Leipzig, Fraunhofer-Institut für Zelltherapie und Immunologie, Universitätsklinikum, ACOMED statistik, co.don AG, University of Texas HSC San Antonio, BioMed Central |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Source | Journal of translational medicine 2015, 13:160 |
| Rights | info:eu-repo/semantics/openAccess |
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