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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
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
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.
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

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