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Production of mesenchymal stromal/stem cells according to good manufacturing practices: a review.

Abstract：

:Because of their multi/pluripotency and immunosuppressive properties, mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs, their definition as advanced-therapy medicinal products in European regulations, and the US Food and Drug Administration requirements for their production and use imply the use of production processes that should be in accordance with Good Manufacturing Practices (GMPs). Complying with GMPs requires precisely defining the production process (es) as well as the multiple criteria required for a quality final product. Such variables include the environment, staff training and qualification, and controls. Developing processes based on well-defined or completely defined media and operating in closed systems or bioreactors is important and will increase safety and reproducibility. One of the most challenging issues remains implementation of relevant and reproducible controls for safety and efficacy. A linking of researchers, research and development teams, producers, and clinicians is mandatory to achieve GMP-compliant processes with relevant controls for producing well-defined, safe, and efficient MSCs.

journal_name

Stem Cell Res Ther

journal_title

Stem cell research & therapy

authors

Sensebé L,Gadelorge M,Fleury-Cappellesso S

doi

10.1186/scrt217

subject

Has Abstract

pub_date

2013-06-07 00:00:00

pages

66

issue

3

issn

1757-6512

pii

scrt217

journal_volume

4

pub_type

杂志文章,评审

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