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https://doi.org/10.21256/zhaw-3135| Publikationstyp: | Beitrag in wissenschaftlicher Zeitschrift |
| Art der Begutachtung: | Peer review (Publikation) |
| 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 |
| DOI: | 10.21256/zhaw-3135 10.1007/s00253-018-8912-x |
| Erschienen in: | Applied Microbiology and Biotechnology |
| Band(Heft): | 102 |
| Heft: | 9 |
| Seite(n): | 3981 |
| Seiten bis: | 3994 |
| Erscheinungsdatum: | 2018 |
| Verlag / Hrsg. Institution: | Springer |
| ISSN: | 0175-7598 1432-0614 |
| 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. |
| URI: | https://digitalcollection.zhaw.ch/handle/11475/17743 |
| Volltext Version: | Publizierte Version |
| Lizenz (gemäss Verlagsvertrag): | CC BY 4.0: Namensnennung 4.0 International |
| Departement: | Life Sciences und Facility Management |
| Organisationseinheit: | Institut für Chemie und Biotechnologie (ICBT) |
| Enthalten in den Sammlungen: | Publikationen Life Sciences und Facility Management |
Dateien zu dieser Ressource:
| Datei | Beschreibung | Größe | Format | |
|---|---|---|---|---|
| Jossen2018_Article_ManufacturingHumanMesenchymal.pdf | 1.34 MB | Adobe PDF |  Öffnen/Anzeigen |
Zur Langanzeige
Jossen, V., van den Bos, C., Eibl-Schindler, R., & Eibl, D. (2018). Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges. Applied Microbiology and Biotechnology, 102(9), 3981–3994. https://doi.org/10.21256/zhaw-3135
Jossen, V. et al. (2018) ‘Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges’, Applied Microbiology and Biotechnology, 102(9), pp. 3981–3994. Available at: https://doi.org/10.21256/zhaw-3135.
V. Jossen, C. van den Bos, R. Eibl-Schindler, and D. Eibl, “Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges,” Applied Microbiology and Biotechnology, vol. 102, no. 9, pp. 3981–3994, 2018, doi: 10.21256/zhaw-3135.
JOSSEN, Valentin, Christian VAN DEN BOS, Regine EIBL-SCHINDLER und Dieter EIBL, 2018. Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges. Applied Microbiology and Biotechnology. 2018. Bd. 102, Nr. 9, S. 3981–3994. DOI 10.21256/zhaw-3135
Jossen, Valentin, Christian van den Bos, Regine Eibl-Schindler, and Dieter Eibl. 2018. “Manufacturing Human Mesenchymal Stem Cells at Clinical Scale : Process and Regulatory Challenges.” Applied Microbiology and Biotechnology 102 (9): 3981–94. https://doi.org/10.21256/zhaw-3135.
Jossen, Valentin, et al. “Manufacturing Human Mesenchymal Stem Cells at Clinical Scale : Process and Regulatory Challenges.” Applied Microbiology and Biotechnology, vol. 102, no. 9, 2018, pp. 3981–94, https://doi.org/10.21256/zhaw-3135.
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