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Titel: Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges
Autor/-in: Jossen, Valentin
van den Bos, Christian
Eibl-Schindler, Regine
Eibl, Dieter
et. al: No
Erschienen in: Applied Microbiology and Biotechnology
Band(Heft): 102
Heft: 9
Seiten: 3981
Seiten bis: 3994
Verlag / Hrsg. Institution: Springer
Erscheinungsdatum: 2018
Lizenz (gemäss Verlagsvertrag): CC BY 4.0: Namensnennung 4.0 International
Art der Begutachtung: Peer review (Publikation)
Sprache: Englisch
Schlagwörter: Advanced therapeutic medicinal product; Allogeneic; Good manufacturing practice; Human mesenchymal stem cell; Microcarrier; Single-use device; Bioreactor; Cell culture technique; Mesenchymal stem cell; Biomedical technology assessment; Cell- and tissue-based therapy
Fachgebiet (DDC): 660.6: Biotechnologie
Zusammenfassung: Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.
Departement: Life Sciences und Facility Management
Organisationseinheit: Institut für Chemie und Biotechnologie (ICBT)
Publikationstyp: Beitrag in wissenschaftlicher Zeitschrift
DOI: 10.21256/zhaw-3135
10.1007/s00253-018-8912-x
ISSN: 0175-7598
1432-0614
URI: https://digitalcollection.zhaw.ch/handle/11475/17743
Enthalten in den Sammlungen:Publikationen Life Sciences und Facility Management

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