Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects
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 m...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Stem Cells International |
| Online Access: | http://dx.doi.org/10.1155/2016/9783408 |
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| _version_ | 1832556812661948416 |
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| author | Patricia Galvez-Martin Roger Sabata Josep Verges José L. Zugaza Adolfina Ruiz Beatriz Clares |
| author_facet | Patricia Galvez-Martin Roger Sabata Josep Verges José L. Zugaza Adolfina Ruiz Beatriz Clares |
| author_sort | Patricia Galvez-Martin |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4ab31f1ef3f8470bad1bb6cd577e2f6a |
| institution | Kabale University |
| issn | 1687-966X 1687-9678 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stem Cells International |
| spelling | doaj-art-4ab31f1ef3f8470bad1bb6cd577e2f6a2025-02-03T05:44:22ZengWileyStem Cells International1687-966X1687-96782016-01-01201610.1155/2016/97834089783408Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory AspectsPatricia Galvez-Martin0Roger Sabata1Josep Verges2José L. Zugaza3Adolfina Ruiz4Beatriz Clares5Advanced Therapies Area, Bioibérica S.A., 08029 Barcelona, SpainAdvanced Therapies Area, Bioibérica S.A., 08029 Barcelona, SpainAdvanced Therapies Area, Bioibérica S.A., 08029 Barcelona, SpainDepartment of Genetics, Physical Anthropology and Animal Physiology, University of the Basque Country, 48940 Leioa, SpainDepartment of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 180171 Granada, SpainDepartment of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 180171 Granada, SpainMesenchymal 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.http://dx.doi.org/10.1155/2016/9783408 |
| spellingShingle | Patricia Galvez-Martin Roger Sabata Josep Verges José L. Zugaza Adolfina Ruiz Beatriz Clares Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects Stem Cells International |
| title | Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects |
| title_full | Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects |
| title_fullStr | Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects |
| title_full_unstemmed | Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects |
| title_short | Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects |
| title_sort | mesenchymal stem cells as therapeutics agents quality and environmental regulatory aspects |
| url | http://dx.doi.org/10.1155/2016/9783408 |
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