Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome
MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesen...
| Autores: | , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Universidad de Navarra |
| Repositorio: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglés |
| OAI Identifier: | oai:dadun.unav.edu:10171/116701 |
| Acceso en línea: | https://hdl.handle.net/10171/116701 |
| Access Level: | acceso abierto |
| Palabra clave: | ATMPs GMP manufacturing MSCs Extracellular vesicles Legal requirements |
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Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcomeFernández-Santos, M.E. (María Eugenia)|||/items/140cf7a6-b4d8-41c0-a0c2-7788f044c39bGarcía-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5Andreu, E.J. (Enrique José)|||/items/bfb7adec-1ed3-4313-a2a7-8b026c48eba6García-Hernández, A.M. (Ana Maria)|||/items/4c6b0ee2-6c7a-4e3a-91c9-51bfec36e3acLopez-Parra, M. (Miriam)|||/items/5e1bb5db-95e6-4107-ab31-89287abeb248Villarón, E. (Eva)|||/items/64cf3b68-33a8-45db-ad05-b49c2b740cf6Sepúlveda, P. (Pilar)|||/items/6812bc9d-bb9a-4561-89bc-40e4434b0799Fernandez-Aviles, F. (Francisco)|||/items/b2f2d78a-c943-4591-8b6f-73f5b11576f0Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49Moraleda, J. M. (José M.)|||/items/6a96c554-773d-428a-9003-41d37bb21477Zapata, A. (Agustín)|||/items/139101da-64e6-498e-a379-5a1f059064ebATMPsGMP manufacturingMSCsExtracellular vesiclesLegal requirementsMSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs.Frontiers Media S.A.Dadun. Depósito Académico Digital Universidad de Navarra20222022-01-0120222022-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/116701reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/1167012026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| title |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| spellingShingle |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome Fernández-Santos, M.E. (María Eugenia)|||/items/140cf7a6-b4d8-41c0-a0c2-7788f044c39b ATMPs GMP manufacturing MSCs Extracellular vesicles Legal requirements |
| title_short |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| title_full |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| title_fullStr |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| title_full_unstemmed |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| title_sort |
Optimization of Mesenchymal Stromal Cell (MSC) manufacturing processes for a better therapeutic outcome |
| dc.creator.none.fl_str_mv |
Fernández-Santos, M.E. (María Eugenia)|||/items/140cf7a6-b4d8-41c0-a0c2-7788f044c39b García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Andreu, E.J. (Enrique José)|||/items/bfb7adec-1ed3-4313-a2a7-8b026c48eba6 García-Hernández, A.M. (Ana Maria)|||/items/4c6b0ee2-6c7a-4e3a-91c9-51bfec36e3ac Lopez-Parra, M. (Miriam)|||/items/5e1bb5db-95e6-4107-ab31-89287abeb248 Villarón, E. (Eva)|||/items/64cf3b68-33a8-45db-ad05-b49c2b740cf6 Sepúlveda, P. (Pilar)|||/items/6812bc9d-bb9a-4561-89bc-40e4434b0799 Fernandez-Aviles, F. (Francisco)|||/items/b2f2d78a-c943-4591-8b6f-73f5b11576f0 Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Moraleda, J. M. (José M.)|||/items/6a96c554-773d-428a-9003-41d37bb21477 Zapata, A. (Agustín)|||/items/139101da-64e6-498e-a379-5a1f059064eb |
| author |
Fernández-Santos, M.E. (María Eugenia)|||/items/140cf7a6-b4d8-41c0-a0c2-7788f044c39b |
| author_facet |
Fernández-Santos, M.E. (María Eugenia)|||/items/140cf7a6-b4d8-41c0-a0c2-7788f044c39b García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Andreu, E.J. (Enrique José)|||/items/bfb7adec-1ed3-4313-a2a7-8b026c48eba6 García-Hernández, A.M. (Ana Maria)|||/items/4c6b0ee2-6c7a-4e3a-91c9-51bfec36e3ac Lopez-Parra, M. (Miriam)|||/items/5e1bb5db-95e6-4107-ab31-89287abeb248 Villarón, E. (Eva)|||/items/64cf3b68-33a8-45db-ad05-b49c2b740cf6 Sepúlveda, P. (Pilar)|||/items/6812bc9d-bb9a-4561-89bc-40e4434b0799 Fernandez-Aviles, F. (Francisco)|||/items/b2f2d78a-c943-4591-8b6f-73f5b11576f0 Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Moraleda, J. M. (José M.)|||/items/6a96c554-773d-428a-9003-41d37bb21477 Zapata, A. (Agustín)|||/items/139101da-64e6-498e-a379-5a1f059064eb |
| author_role |
author |
| author2 |
García-Arranz, M. (Mariano)|||/items/2975353c-dcc6-482f-93e9-60b5dec8d4b5 Andreu, E.J. (Enrique José)|||/items/bfb7adec-1ed3-4313-a2a7-8b026c48eba6 García-Hernández, A.M. (Ana Maria)|||/items/4c6b0ee2-6c7a-4e3a-91c9-51bfec36e3ac Lopez-Parra, M. (Miriam)|||/items/5e1bb5db-95e6-4107-ab31-89287abeb248 Villarón, E. (Eva)|||/items/64cf3b68-33a8-45db-ad05-b49c2b740cf6 Sepúlveda, P. (Pilar)|||/items/6812bc9d-bb9a-4561-89bc-40e4434b0799 Fernandez-Aviles, F. (Francisco)|||/items/b2f2d78a-c943-4591-8b6f-73f5b11576f0 Garcia-Olmos, D. (Damián)|||/items/326e762c-fb72-468b-87f4-ecae2c861998 Prosper-Cardoso, F. (Felipe)|||/items/3d1b0b82-06c3-4e63-8280-e903dc4dc0c1 Sanchez-Guijo, F.M. (Fermín M.)|||/items/b31fe6cf-bc6a-42fb-8a92-116c4f62dd49 Moraleda, J. M. (José M.)|||/items/6a96c554-773d-428a-9003-41d37bb21477 Zapata, A. (Agustín)|||/items/139101da-64e6-498e-a379-5a1f059064eb |
| author2_role |
author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
ATMPs GMP manufacturing MSCs Extracellular vesicles Legal requirements |
| topic |
ATMPs GMP manufacturing MSCs Extracellular vesicles Legal requirements |
| description |
MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs. |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 2022-01-01 2022 2022-01-01 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10171/116701 |
| url |
https://hdl.handle.net/10171/116701 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
Frontiers Media S.A. |
| publisher.none.fl_str_mv |
Frontiers Media S.A. |
| dc.source.none.fl_str_mv |
reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
| reponame_str |
Dadun. Depósito Académico Digital de la Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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1869419020336234496 |
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15,811543 |