Return to search

Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP)

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.

Identiferoai:union.ndltd.org:DRESDEN/oai:qucosa.de:bsz:15-qucosa-170184
Date27 July 2015
CreatorsZscharnack, 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
ContributorsUniversität Leipzig, Translationszentrum für Regenerative Medizin, Fraunhofer-Institut für Zelltherapie und Immunologie,, Universitätsklinikum, Forschungslabore, Universität Leipzig, Biotechnologisch-Biomedizinische Zentrum, ACOMED statistik,, co.don AG,, University of Texas HSC San Antonio, Department of Orthopaedics, BioMed Central,
PublisherUniversitätsbibliothek Leipzig
Source SetsHochschulschriftenserver (HSSS) der SLUB Dresden
LanguageEnglish
Detected LanguageEnglish
Typedoc-type:article
Formatapplication/pdf
SourceJournal of translational medicine 2015, 13:160

Page generated in 0.0023 seconds