Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly

Cell culture; Cellular therapy; Good manufacturing practice

Detalhes bibliográficos
Autores: Grau Vorster, Marta, Rodríguez Gómez, Luciano, Mazo Barbara, Anna del, Clementine, Mirabel, Ortega Blanco, Margarita, Codinach Creus, Margarita, Vives Armengol, Joaquim
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/4146
Acesso em linha:https://hdl.handle.net/11351/4146
http://hdl.handle.net/11351/4146
Access Level:acceso abierto
Palavra-chave:Cèl·lules mare mesenquimàtiques
Immunització - Control de qualitat
ANATOMY::Tissues::Connective Tissue::Wharton Jelly
ANATOMY::Cells::Connective Tissue Cells::Stromal Cells::Mesenchymal Stromal Cells
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation
TECHNOLOGY, INDUSTRY, AGRICULTURE::Technology, Industry, and Agriculture::Technology::Quality Control
ANATOMÍA::tejidos::tejido conectivo::gelatina de Wharton
ANATOMÍA::células::células del tejido conectivo::células del estroma::células madre mesenquimatosas
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::control de calidad
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network_acronym_str ES
network_name_str España
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dc.title.none.fl_str_mv Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
title Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
spellingShingle Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
Grau Vorster, Marta
Cèl·lules mare mesenquimàtiques
Immunització - Control de qualitat
ANATOMY::Tissues::Connective Tissue::Wharton Jelly
ANATOMY::Cells::Connective Tissue Cells::Stromal Cells::Mesenchymal Stromal Cells
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation
TECHNOLOGY, INDUSTRY, AGRICULTURE::Technology, Industry, and Agriculture::Technology::Quality Control
ANATOMÍA::tejidos::tejido conectivo::gelatina de Wharton
ANATOMÍA::células::células del tejido conectivo::células del estroma::células madre mesenquimatosas
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::control de calidad
title_short Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
title_full Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
title_fullStr Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
title_full_unstemmed Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
title_sort Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly
dc.creator.none.fl_str_mv Grau Vorster, Marta
Rodríguez Gómez, Luciano
Mazo Barbara, Anna del
Clementine, Mirabel
Ortega Blanco, Margarita
Codinach Creus, Margarita
Vives Armengol, Joaquim
author Grau Vorster, Marta
author_facet Grau Vorster, Marta
Rodríguez Gómez, Luciano
Mazo Barbara, Anna del
Clementine, Mirabel
Ortega Blanco, Margarita
Codinach Creus, Margarita
Vives Armengol, Joaquim
author_role author
author2 Rodríguez Gómez, Luciano
Mazo Barbara, Anna del
Clementine, Mirabel
Ortega Blanco, Margarita
Codinach Creus, Margarita
Vives Armengol, Joaquim
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Grau-Vorster M] Banc de Sang i Teixits, Barcelona, Spain. Grup de Medicina Transfusional, Vall d’Hebron Institut de Recerca, Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain. [Rodríguez L, Del Mazo-Barbara A, Mirabel C, Blanco M, Codinach M] Banc de Sang i Teixits, Barcelona, Spain. [Vives J] Banc de Sang i Teixits, Barcelona, Spain. Grup de Enginyeria tissular musculoesquelètica, Vall d’Hebron Institut de Recerca, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Cèl·lules mare mesenquimàtiques
Immunització - Control de qualitat
ANATOMY::Tissues::Connective Tissue::Wharton Jelly
ANATOMY::Cells::Connective Tissue Cells::Stromal Cells::Mesenchymal Stromal Cells
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation
TECHNOLOGY, INDUSTRY, AGRICULTURE::Technology, Industry, and Agriculture::Technology::Quality Control
ANATOMÍA::tejidos::tejido conectivo::gelatina de Wharton
ANATOMÍA::células::células del tejido conectivo::células del estroma::células madre mesenquimatosas
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::control de calidad
topic Cèl·lules mare mesenquimàtiques
Immunització - Control de qualitat
ANATOMY::Tissues::Connective Tissue::Wharton Jelly
ANATOMY::Cells::Connective Tissue Cells::Stromal Cells::Mesenchymal Stromal Cells
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation
TECHNOLOGY, INDUSTRY, AGRICULTURE::Technology, Industry, and Agriculture::Technology::Quality Control
ANATOMÍA::tejidos::tejido conectivo::gelatina de Wharton
ANATOMÍA::células::células del tejido conectivo::células del estroma::células madre mesenquimatosas
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::control de calidad
description Cell culture; Cellular therapy; Good manufacturing practice
publishDate 2019
dc.date.none.fl_str_mv 2019
2019
2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/4146
http://hdl.handle.net/11351/4146
url https://hdl.handle.net/11351/4146
http://hdl.handle.net/11351/4146
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Cells;8(5)
https://www.mdpi.com/2073-4409/8/5/484
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869411535621718016
spelling Compliance with Good Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s JellyGrau Vorster, MartaRodríguez Gómez, LucianoMazo Barbara, Anna delClementine, MirabelOrtega Blanco, MargaritaCodinach Creus, MargaritaVives Armengol, JoaquimCèl·lules mare mesenquimàtiquesImmunització - Control de qualitatANATOMY::Tissues::Connective Tissue::Wharton JellyANATOMY::Cells::Connective Tissue Cells::Stromal Cells::Mesenchymal Stromal CellsANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Therapeutics::Biological Therapy::ImmunomodulationTECHNOLOGY, INDUSTRY, AGRICULTURE::Technology, Industry, and Agriculture::Technology::Quality ControlANATOMÍA::tejidos::tejido conectivo::gelatina de WhartonANATOMÍA::células::células del tejido conectivo::células del estroma::células madre mesenquimatosasTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulaciónTECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::control de calidadCell culture; Cellular therapy; Good manufacturing practiceCultiu cel·lular; Teràpia cel·lular; Bones pràctiques de manufacturaCultivo celular; Terapia celular; Buenas prácticas de fabricaciónThe selection of assays suitable for testing the potency of clinical grade multipotent mesenchymal stromal cell (MSC)-based products and its interpretation is a challenge for both developers and regulators. Here, we present a bioprocess design for the production of Wharton's jelly (WJ)-derived MSCs and a validated immunopotency assay approved by the competent regulatory authority for batch release together with the study of failure modes in the bioprocess with potential impact on critical quality attributes (CQA) of the final product. Methods: The lymphocyte proliferation assay was used for determining the immunopotency of WJ-MSCs and validated under good manufacturing practices (GMP). Moreover, failure mode effects analysis (FMEA) was used to identify and quantify the potential impact of different unexpected situations on the CQA. Results: A production process based on a two-tiered cell banking strategy resulted in batches with sufficient numbers of cells for clinical use in compliance with approved specifications including MSC identity (expressing CD73, CD90, CD105, but not CD31, CD45, or HLA-DR). Remarkably, all batches showed high capacity to inhibit the proliferation of activated lymphocytes. Moreover, implementation of risk management tools led to an in-depth understanding of the manufacturing process as well as the identification of weak points to be reinforced. Conclusions: The bioprocess design showed here together with detailed risk management and the use of a robust method for immunomodulation potency testing allowed for the robust production of clinical-grade WJ-MSCs under pharmaceutical standards.MDPIInstitut Català de la Salut[Grau-Vorster M] Banc de Sang i Teixits, Barcelona, Spain. Grup de Medicina Transfusional, Vall d’Hebron Institut de Recerca, Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain. [Rodríguez L, Del Mazo-Barbara A, Mirabel C, Blanco M, Codinach M] Banc de Sang i Teixits, Barcelona, Spain. [Vives J] Banc de Sang i Teixits, Barcelona, Spain. Grup de Enginyeria tissular musculoesquelètica, Vall d’Hebron Institut de Recerca, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.Vall d'Hebron Barcelona Hospital Campus201920192019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/4146http://hdl.handle.net/11351/4146Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésCells;8(5)https://www.mdpi.com/2073-4409/8/5/484Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/41462026-05-29T05:05:01Z
score 15,812429

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