Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges.
Appl Microbiol Biotechnol
; 102(9): 3981-3994, 2018 May.
Article
in En
| MEDLINE
| ID: mdl-29564526
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cell Culture Techniques
/
Cell- and Tissue-Based Therapy
Type of study:
Health_technology_assessment
Limits:
Humans
Language:
En
Journal:
Appl Microbiol Biotechnol
Year:
2018
Document type:
Article
Affiliation country:
Switzerland