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https://doi.org/10.21256/zhaw-3135| Publication type: | Article in scientific journal |
| Type of review: | Peer review (publication) |
| Title: | Manufacturing human mesenchymal stem cells at clinical scale : process and regulatory challenges |
| Authors : | 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 |
| Published in : | Applied Microbiology and Biotechnology |
| Volume(Issue) : | 102 |
| Issue : | 9 |
| Pages : | 3981 |
| Pages to: | 3994 |
| Issue Date: | 2018 |
| Publisher / Ed. Institution : | Springer |
| ISSN: | 0175-7598 1432-0614 |
| Language : | English |
| Subjects : | 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 |
| Subject (DDC) : | 660.6: Biotechnology |
| Abstract: | 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 |
| Fulltext version : | Published version |
| License (according to publishing contract) : | CC BY 4.0: Attribution 4.0 International |
| Departement: | Life Sciences and Facility Management |
| Organisational Unit: | Institute of Chemistry and Biotechnology (ICBT) |
| Appears in Collections: | Publikationen Life Sciences und Facility Management |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Jossen2018_Article_ManufacturingHumanMesenchymal.pdf | 1.34 MB | Adobe PDF |  View/Open |
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