Optimization of Mesenchymal Stromal Cell (MSC) Manufacturing Processes for a Better Therapeutic Outcome

Data de publicació: 09/06/2022 Data Ahead of Print: 09/06/2022

Autors de IIS La Fe

Pilar Sepúlveda Sanchis

Autor

Autors aliens a IIS La Fe

Fernandez-Santos, Maria Eugenia
Garcia-Arranz, Mariano
Andreu, Enrique J.
Garcia-Hernandez, Ana Maria
Lopez-Parra, Miriam
Villaron, Eva
Fernandez-Aviles, Francisco
Garcia-Olmo, Damian
Prosper, Felipe
Sanchez-Guijo, Fermin
Moraleda, Jose M.
Zapata, Agustin G.

Grups d'Investigació

Regeneración y Trasplante Cardíaco

Leader

Pilar Sepúlveda Sanchis

Abstract

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.

Dades de la publicació

ISSN/ISSNe:: 1664-3224, 1664-3224
Tipus:: Article
Pàgines:: 918565-918565
DOI:: 10.3389/fimmu.2022.918565
PubMed:: 35812460
Factor d'Impacte:: 2,331 SCImago ℠
Quartil:: Q1 SCImago ℠

Documents

No hi ha documents

Mètriques

Filiacions

Fernandez-Santos, Maria Eugenia:: Cardiology Department, HGU Gregorio Marañón. GMP-ATMPs Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM). Complutense University, CIBER Cardiovascular (CIBERCV), ISCIII, Madrid, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Garcia-Arranz, Mariano:: New Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD). Surgery Department, Autonoma University of Madrid, Madrid, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Andreu, Enrique J.:: Hematology Department and Cell Therapy Area, Clínica Universidad de Navarra. CIBEROC and IDISNA, Pamplona, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Garcia-Hernandez, Ana Maria:: Hematopoietic Transplant and Cellular Therapy Unit, Instituto Murciano de Investigación Biosanitaria IMIB-Arrixaca, Virgen de la Arrixaca University Hospital, University of Murcia, Murcia, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Lopez-Parra, Miriam:: Cell Therapy Area and Hematology Department, IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Villaron, Eva:: Cell Therapy Area and Hematology Department, IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Sepulveda, Pilar:: Regenerative Medicine and Heart Transplantation Unit, Instituto de Investigación Sanitaria La Fe, Valencia, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Fernandez-Aviles, Francisco:: Cardiology Department, HGU Gregorio Marañón. GMP-ATMPs Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM). Complutense University, CIBER Cardiovascular (CIBERCV), ISCIII, Madrid, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Garcia-Olmo, Damian:: New Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD). Surgery Department, Autonoma University of Madrid, Madrid, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Prosper, Felipe:: Hematology Department and Cell Therapy Area, Clínica Universidad de Navarra. CIBEROC and IDISNA, Pamplona, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Sanchez-Guijo, Fermin:: Cell Therapy Area and Hematology Department, IBSAL-University Hospital of Salamanca, University of Salamanca, Salamanca, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Moraleda, Jose M.:: Hematopoietic Transplant and Cellular Therapy Unit, Instituto Murciano de Investigación Biosanitaria IMIB-Arrixaca, Virgen de la Arrixaca University Hospital, University of Murcia, Murcia, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain
Zapata, Agustin G.:: Department of Cell Biology, Complutense University, Madrid, Spain

Platform GMP Units from TerCel and TERAV Networks. RETIC TerCel & RICORS TERAV, ISCIII, Madrid, Spain