Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-3135
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
Published in : Applied microbiology and biotechnology
Volume(Issue) : 102
Issue : 9
Pages : 3981
Pages to: 3994
Publisher / Ed. Institution : Springer
Issue Date: 2018
License (according to publishing contract) : CC BY 4.0: Attribution 4.0 International
Type of review: Peer review (publication)
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.
Departement: Life Sciences and Facility Management
Organisational Unit: Institute of Chemistry and Biotechnology (ICBT)
Publication type: Article in scientific journal
DOI : 10.21256/zhaw-3135
10.1007/s00253-018-8912-x
ISSN: 0175-7598
1432-0614
URI: https://digitalcollection.zhaw.ch/handle/11475/17743
Appears in Collections:Publikationen Life Sciences und Facility Management

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