Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control

Chimeric antigen receptor T cells (CAR-T), especially against CD19 marker, present in lymphomas and acute B leukemia, enabled a revolution in the treatment of hematologic neoplastic diseases. The manufacture of CAR-T cells requires the adoption of GMP-compatible methods and it demands the collection...

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Autores principales:	Gil Cunha De Santis, Dante Mário Langhi Junior, Andreza Feitoza, Alfredo Mendrone Junior, José Mauro Kutner, Dimas Tadeu Covas, Samuel Campanelli Freitas Couto, Renato L. Guerino-Cunha, Maristela Delgado Orellana, Sílvia Renata Cornelio Parolin Rizzo
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Adoptive cellular immunotherapy CAR-T cell therapy Cryopreservation Quality control Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/a0bd95033e124bd38e266ed79eec3c57
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spelling	oai:doaj.org-article:a0bd95033e124bd38e266ed79eec3c572021-11-18T04:51:01ZAssociação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control2531-137910.1016/j.htct.2021.09.005https://doaj.org/article/a0bd95033e124bd38e266ed79eec3c572021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2531137921001395https://doaj.org/toc/2531-1379Chimeric antigen receptor T cells (CAR-T), especially against CD19 marker, present in lymphomas and acute B leukemia, enabled a revolution in the treatment of hematologic neoplastic diseases. The manufacture of CAR-T cells requires the adoption of GMP-compatible methods and it demands the collection of mononuclear cells from the patient (or from the donor), generally through the apheresis procedure, T cell selection, activation, transduction and expansion ex vivo, and finally storage, usually cryopreserved, until the moment of their use. An important aspect is the quality control testing of the final product, for example, the characterization of its identity and purity, tests to detect any contamination by microorganisms (bacteria, fungi, and mycoplasma) and its potency. The product thawing and intravenous infusion do not differ much from what is established for the hematopoietic progenitor cell product. After infusion, it is important to check for the presence and concentration of CAR-T cells in the patient's peripheral blood, as well as to monitor their clinical impact, for instance, the occurrence of short-term, such as cytokine release syndrome and neurological complications, and long-term complications, which require patient follow-up for many years.Gil Cunha De SantisDante Mário Langhi JuniorAndreza FeitozaAlfredo Mendrone JuniorJosé Mauro KutnerDimas Tadeu CovasSamuel Campanelli Freitas CoutoRenato L. Guerino-CunhaMaristela Delgado OrellanaSílvia Renata Cornelio Parolin RizzoElsevierarticleAdoptive cellular immunotherapyCAR-T cell therapyCryopreservationQuality controlDiseases of the blood and blood-forming organsRC633-647.5ENHematology, Transfusion and Cell Therapy, Vol 43, Iss , Pp S35-S41 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Adoptive cellular immunotherapy CAR-T cell therapy Cryopreservation Quality control Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Adoptive cellular immunotherapy CAR-T cell therapy Cryopreservation Quality control Diseases of the blood and blood-forming organs RC633-647.5 Gil Cunha De Santis Dante Mário Langhi Junior Andreza Feitoza Alfredo Mendrone Junior José Mauro Kutner Dimas Tadeu Covas Samuel Campanelli Freitas Couto Renato L. Guerino-Cunha Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
description	Chimeric antigen receptor T cells (CAR-T), especially against CD19 marker, present in lymphomas and acute B leukemia, enabled a revolution in the treatment of hematologic neoplastic diseases. The manufacture of CAR-T cells requires the adoption of GMP-compatible methods and it demands the collection of mononuclear cells from the patient (or from the donor), generally through the apheresis procedure, T cell selection, activation, transduction and expansion ex vivo, and finally storage, usually cryopreserved, until the moment of their use. An important aspect is the quality control testing of the final product, for example, the characterization of its identity and purity, tests to detect any contamination by microorganisms (bacteria, fungi, and mycoplasma) and its potency. The product thawing and intravenous infusion do not differ much from what is established for the hematopoietic progenitor cell product. After infusion, it is important to check for the presence and concentration of CAR-T cells in the patient's peripheral blood, as well as to monitor their clinical impact, for instance, the occurrence of short-term, such as cytokine release syndrome and neurological complications, and long-term complications, which require patient follow-up for many years.
format	article
author	Gil Cunha De Santis Dante Mário Langhi Junior Andreza Feitoza Alfredo Mendrone Junior José Mauro Kutner Dimas Tadeu Covas Samuel Campanelli Freitas Couto Renato L. Guerino-Cunha Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo
author_facet	Gil Cunha De Santis Dante Mário Langhi Junior Andreza Feitoza Alfredo Mendrone Junior José Mauro Kutner Dimas Tadeu Covas Samuel Campanelli Freitas Couto Renato L. Guerino-Cunha Maristela Delgado Orellana Sílvia Renata Cornelio Parolin Rizzo
author_sort	Gil Cunha De Santis
title	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
title_short	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
title_full	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
title_fullStr	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
title_full_unstemmed	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control
title_sort	associação brasileira de hematologia, hemoterapia e terapia celular consensus on genetically modified cells. v: manufacture and quality control
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/a0bd95033e124bd38e266ed79eec3c57
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Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. V: Manufacture and quality control

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