Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects.

Abstract:

: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.

journal_name

Stem Cells Int

journal_title

Stem cells international

authors

Galvez-Martin P,Sabata R,Verges J,Zugaza JL,Ruiz A,Clares B

doi

10.1155/2016/9783408

subject

Has Abstract

pub_date

2016-01-01 00:00:00

pages

9783408

eissn

1687-966X

issn

1687-9678

journal_volume

2016

pub_type

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