title: Quality of Cell Products: Authenticity, Identity, Genomic Stability and Status of Differentiation.
abstract: Cellular therapies that either use modifications of a patient's own cells or allogeneic cell lines are becoming in vogue. Besides the technical issues of optimal isolation, cultivation and modification, quality control of the generated cellular products are increasingly being considered to be more important. This is not only relevant for the cell's therapeutic application but also for cell science in general. Recent changes in editorial policies of respected journals, which now require proof of authenticity when cell lines are used, demonstrate that the subject of the present paper is not a virtual problem at all. In this article we provide 2 examples of contaminated cell lines followed by a review of the recent developments used to verify cell lines, stem cells and modifications of autologous cells. With relative simple techniques one can now prove the authenticity and the quality of the cellular material of interest and therefore improve the scientific basis for the development of cells for therapeutic applications. The future of advanced cellular therapies will require production and characterization of cells under GMP and GLP conditions, which include proof of identity, safety and functionality and absence of contamination.
authors.affiliation: Department of Molecular Biotechnology, Helmholtz Centre for Infection Research (HZI) Braunschweig, Braunschweig, Germany.
authors.forename: Kurt E J
authors.initials: KE
authors.lastname: Dittmar
authors.forename: Meike
authors.initials: M
authors.lastname: Simann
authors.forename: Nadia
authors.initials: N
authors.lastname: Zghoul
authors.forename: Oliver
authors.initials: O
authors.lastname: Schön
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Meyring
authors.forename: Horst
authors.initials: H
authors.lastname: Hannig
authors.forename: Lars
authors.initials: L
authors.lastname: Macke
authors.forename: Wilhelm G
authors.initials: WG
authors.lastname: Dirks
authors.forename: Konstantin
authors.initials: K
authors.lastname: Miller
authors.forename: Henk S P
authors.initials: HS
authors.lastname: Garritsen
authors.forename: Werner
authors.initials: W
authors.lastname: Lindenmaier