Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects
Joint Authors
Galvez-Martin, Patricia
Sabata, Roger
Verges, Josep
Zugaza, José L.
Ruiz, Adolfina
Clares, Beatriz
Source
Issue
Vol. 2016, Issue 2016 (31 Dec. 2015), pp.1-14, 14 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-11-24
Country of Publication
Egypt
No. of Pages
14
Abstract EN
Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine.
To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs).
The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights.
The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP).
Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs.
One of these important and complex requirements is the environmental monitoring.
Although a number of environmental requirements are clearly defined, some others are provided as recommendations.
In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.
American Psychological Association (APA)
Galvez-Martin, Patricia& Sabata, Roger& Verges, Josep& Zugaza, José L.& Ruiz, Adolfina& Clares, Beatriz. 2016. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International،Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1117477
Modern Language Association (MLA)
Galvez-Martin, Patricia…[et al.]. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International Vol. 2016, no. 2016 (2015), pp.1-14.
https://search.emarefa.net/detail/BIM-1117477
American Medical Association (AMA)
Galvez-Martin, Patricia& Sabata, Roger& Verges, Josep& Zugaza, José L.& Ruiz, Adolfina& Clares, Beatriz. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells International. 2016. Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1117477
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1117477