Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2023 |
| Outros Autores: | , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | por |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/60773 |
Resumo: | Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil. |
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Rebelatto, Carmen Lúcia KuniyoshiBoldrini-Leite, Lidiane MariaDaga, Debora ReginaMarsaro, Daniela BoscaroVaz, Isadora MayJamur, Valderez RavaglioAguiar, Alessandra Melo deVieira, Thalita BastidaFurman, Bianca PolakAguiar, Cecília OliveiraBrofman, Paulo Roberto Slud2023-10-11T16:00:03Z2023-10-11T16:00:03Z2023REBELATTO, Carmen Lúcia Kuniyoshi et al. Quality control optimization for minimizing security risks associated with Mesenchymal Stromal Cell-based product development. Int. J. Mol. Sci. v. 24, n. 12955, p. 1-24, 2023.1422-0067https://www.arca.fiocruz.br/handle/icict/60773porMDPIQuality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product developmentinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlePontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Carlos Chagas. Laboratório de Biologia Básica de Células Tronco. Curitiba, PR, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil.Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil.Mesenchymal stromal cells (MSCs) have been considered a therapeutic strategy in regenerative medicine because of their regenerative and immunomodulatory properties. The translation of MSC-based products has some challenges, such as regulatory and scientific issues. Quality control should be standardized and optimized to guarantee the reproducibility, safety, and efficacy of MSC-based products to be administered to patients. The aim of this study was to develop MSCbased products for use in clinical practice. Quality control assays include cell characterization, cell viability, immunogenicity, and cell differentiation; safety tests such as procoagulant tissue factor (TF), microbiological, mycoplasma, endotoxin, genomic stability, and tumorigenicity tests; and potency tests. The results confirm that the cells express MSC markers; an average cell viability of 96.9%; a low expression of HLA-DR and costimulatory molecules; differentiation potential; a high expression of TF/CD142; an absence of pathogenic microorganisms; negative endotoxins; an absence of chromosomal abnormalities; an absence of genotoxicity and tumorigenicity; and T-lymphocyte proliferation inhibition potential. This study shows the relevance of standardizing the manufacturing process and quality controls to reduce variability due to the heterogeneity between donors. The results might also be useful for the implementation and optimization of new analytical techniques and automated methods to improve safety, which are the major concerns related to MSC-based therapy.Good Manufacturing PracticeQuality ControlRegenerative MedicineMesenchymal Stem CellsBuenas Prácticas de FabricaciónControl de CalidadMedicina RegenerativaCélulas Madre MesenquimatosasPratiques de Bonne FabricationContrôle de qualitéMédecine régénérativeCellules souches mésenchymateusesBoas Práticas de FabricaçãoControle de QualidadeMedicina RegenerativaCélulas-Tronco Mesenquimaisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/60773/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALijms-24-12955.pdfijms-24-12955.pdfapplication/pdf3288357https://www.arca.fiocruz.br/bitstream/icict/60773/2/ijms-24-12955.pdf4bb81c8e296286b48df8a1972fccd7fdMD52icict/607732023-10-11 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| dc.title.en_US.fl_str_mv |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| title |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| spellingShingle |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development Rebelatto, Carmen Lúcia Kuniyoshi Good Manufacturing Practice Quality Control Regenerative Medicine Mesenchymal Stem Cells Buenas Prácticas de Fabricación Control de Calidad Medicina Regenerativa Células Madre Mesenquimatosas Pratiques de Bonne Fabrication Contrôle de qualité Médecine régénérative Cellules souches mésenchymateuses Boas Práticas de Fabricação Controle de Qualidade Medicina Regenerativa Células-Tronco Mesenquimais |
| title_short |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| title_full |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| title_fullStr |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| title_full_unstemmed |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| title_sort |
Quality control optimization for minimizing security risks associated with mesenchymal stromal cell-based product development |
| author |
Rebelatto, Carmen Lúcia Kuniyoshi |
| author_facet |
Rebelatto, Carmen Lúcia Kuniyoshi Boldrini-Leite, Lidiane Maria Daga, Debora Regina Marsaro, Daniela Boscaro Vaz, Isadora May Jamur, Valderez Ravaglio Aguiar, Alessandra Melo de Vieira, Thalita Bastida Furman, Bianca Polak Aguiar, Cecília Oliveira Brofman, Paulo Roberto Slud |
| author_role |
author |
| author2 |
Boldrini-Leite, Lidiane Maria Daga, Debora Regina Marsaro, Daniela Boscaro Vaz, Isadora May Jamur, Valderez Ravaglio Aguiar, Alessandra Melo de Vieira, Thalita Bastida Furman, Bianca Polak Aguiar, Cecília Oliveira Brofman, Paulo Roberto Slud |
| author2_role |
author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Rebelatto, Carmen Lúcia Kuniyoshi Boldrini-Leite, Lidiane Maria Daga, Debora Regina Marsaro, Daniela Boscaro Vaz, Isadora May Jamur, Valderez Ravaglio Aguiar, Alessandra Melo de Vieira, Thalita Bastida Furman, Bianca Polak Aguiar, Cecília Oliveira Brofman, Paulo Roberto Slud |
| dc.subject.en.en_US.fl_str_mv |
Good Manufacturing Practice Quality Control Regenerative Medicine Mesenchymal Stem Cells |
| topic |
Good Manufacturing Practice Quality Control Regenerative Medicine Mesenchymal Stem Cells Buenas Prácticas de Fabricación Control de Calidad Medicina Regenerativa Células Madre Mesenquimatosas Pratiques de Bonne Fabrication Contrôle de qualité Médecine régénérative Cellules souches mésenchymateuses Boas Práticas de Fabricação Controle de Qualidade Medicina Regenerativa Células-Tronco Mesenquimais |
| dc.subject.es.en_US.fl_str_mv |
Buenas Prácticas de Fabricación Control de Calidad Medicina Regenerativa Células Madre Mesenquimatosas |
| dc.subject.fr.en_US.fl_str_mv |
Pratiques de Bonne Fabrication Contrôle de qualité Médecine régénérative Cellules souches mésenchymateuses |
| dc.subject.decs.en_US.fl_str_mv |
Boas Práticas de Fabricação Controle de Qualidade Medicina Regenerativa Células-Tronco Mesenquimais |
| description |
Pontificia Universidade Católica do Paraná. Faculdade de Medicina. Núcleo de Tecnologia Celular. Curitiba, PR, Brasil. / Instituto Nacional de Ciência e Tecnologia em Medicina Regenerativa. Rio de Janeiro, RJ, Brasil. |
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2023 |
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2023-10-11T16:00:03Z |
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2023-10-11T16:00:03Z |
| dc.date.issued.fl_str_mv |
2023 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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REBELATTO, Carmen Lúcia Kuniyoshi et al. Quality control optimization for minimizing security risks associated with Mesenchymal Stromal Cell-based product development. Int. J. Mol. Sci. v. 24, n. 12955, p. 1-24, 2023. |
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https://www.arca.fiocruz.br/handle/icict/60773 |
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1422-0067 |
| identifier_str_mv |
REBELATTO, Carmen Lúcia Kuniyoshi et al. Quality control optimization for minimizing security risks associated with Mesenchymal Stromal Cell-based product development. Int. J. Mol. Sci. v. 24, n. 12955, p. 1-24, 2023. 1422-0067 |
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https://www.arca.fiocruz.br/handle/icict/60773 |
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MDPI |
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MDPI |
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