Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products

Detalhes bibliográficos
Autor(a) principal: da Silva, Cristiane Caldeira
Data de Publicação: 2015
Outros Autores: Cruz, Mayara, Freitas, João Carlos, Presgrave, Octavio, Moraes, Aurea, Delgado, Isabella Fernandes
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/519
Resumo: Monocyte Activation Test (MAT) is thought to be a good replacement for rabbit pyrogen test (RPT); however, MAT remains controversial. MAT was not adequately evaluated in a sufficient number of products, and there is no sufficient data that support the ability of MAT to detect non-endotoxin pyrogens. Furthermore, MAT was used subject to validation for each specific product. The aim of this study was to identify in main pharmacopoeias, whose monographs require pyrogenicity tests, and propose those products for which only the rabbit pyrogen test is required to be used as a kick-off study for future studies. Products’ monographs in pharmacopeias in the United States, Europe, and Brazil that are recommended for RPT or Bacterial Endotoxins Test (BET) are as follows. RPT: 20 in American, 37 in European, and 28 in Brazilian pharmacopoeias. BET: 619 in American, 157 in European, and 41 in Brazilian pharmacopoeias. Four products require pyrogenicity testing in three pharmacopoeias. Both RPT and BET are recommended by six monographs in Brazilian pharmacopeias and 15 in European pharmacopoeias. In Brazilian pharmacopoeias most are biological. These products should be the first to be tested for their applicability to MAT because they are currently tested mainly by RPT.
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spelling Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable productsAplicabilidade do Teste de Ativação de Monócitos (MAT) no Brasil: importância da sua utilização como teste para detecção de pirogênios no controle da qualidade de produtos injetáveisTeste da Ativação de MonócitosTeste de PirogêniosFarmacopeiasProdutos BiológicosMonocyte Activation TestRabbit Pyrogen TestPharmacopoeiasBiological productsMonocyte Activation Test (MAT) is thought to be a good replacement for rabbit pyrogen test (RPT); however, MAT remains controversial. MAT was not adequately evaluated in a sufficient number of products, and there is no sufficient data that support the ability of MAT to detect non-endotoxin pyrogens. Furthermore, MAT was used subject to validation for each specific product. The aim of this study was to identify in main pharmacopoeias, whose monographs require pyrogenicity tests, and propose those products for which only the rabbit pyrogen test is required to be used as a kick-off study for future studies. Products’ monographs in pharmacopeias in the United States, Europe, and Brazil that are recommended for RPT or Bacterial Endotoxins Test (BET) are as follows. RPT: 20 in American, 37 in European, and 28 in Brazilian pharmacopoeias. BET: 619 in American, 157 in European, and 41 in Brazilian pharmacopoeias. Four products require pyrogenicity testing in three pharmacopoeias. Both RPT and BET are recommended by six monographs in Brazilian pharmacopeias and 15 in European pharmacopoeias. In Brazilian pharmacopoeias most are biological. These products should be the first to be tested for their applicability to MAT because they are currently tested mainly by RPT.O MAT (sigla do inglês Monocyte Activation Test) é considerado um potencial substituto do Teste de Pirogênios, entretanto: i. não foi avaliado para um número suficiente de produtos; ii. faltam dados que possam garantir sua capacidade em detectar pirogênios não endotoxinas; e iii. deve ser realizada a validação do método para cada classe de produtos. O objetivo foi identificar as monografias que requerem testes de pirogenicidade e propor os produtos que têm por base somente o teste de pirogênios como um ponto de partida para futuros estudos. As monografias específicas nas Farmacopeias Americana, Europeia e Brasileira que recomendam o Teste de Pirogênios ou Teste de Endotoxina Bacteriana ou LAL (sigla do inglês Limulus Amebocyte Lysate) foram: Teste de Pirogênios: 20 monografias na Americana, 37 na Europeia e 28 na Brasileira. LAL: 619 monografias na Americana, 157 na Europeia e 41 na Brasileira. Somente quatro produtos requerem testes de pirogenicidade nas três farmacopeias analisadas. O Teste de Pirogênios e LAL são recomendados em seis monografias na Brasileira e 15 na Europeia. Na Brasileira, a maior parte dessas monografias é referente a produtos biológicos, sugerindo, assim, que estes devam ser os primeiros a ser testados, uma vez que são ensaiados em animais.Instituto Nacional de Controle de Qualidade em Saúde2015-08-26info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/51910.3395/2317-269x.00519Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 3 (2015): August; 41-46Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 3 (2015): Agosto; 41-46Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 3 (2015): Agosto; 41-462317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/519/242Copyright (c) 2015 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessda Silva, Cristiane CaldeiraCruz, MayaraFreitas, João CarlosPresgrave, OctavioMoraes, AureaDelgado, Isabella Fernandes2023-06-27T15:00:17Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/519Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:00:17Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
Aplicabilidade do Teste de Ativação de Monócitos (MAT) no Brasil: importância da sua utilização como teste para detecção de pirogênios no controle da qualidade de produtos injetáveis
title Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
spellingShingle Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
da Silva, Cristiane Caldeira
Teste da Ativação de Monócitos
Teste de Pirogênios
Farmacopeias
Produtos Biológicos
Monocyte Activation Test
Rabbit Pyrogen Test
Pharmacopoeias
Biological products
title_short Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
title_full Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
title_fullStr Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
title_full_unstemmed Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
title_sort Applicability of the Monocyte Activation Test (MAT) in Brazil: the importance of its use as a test for the detection of pyrogens in the quality control of injectable products
author da Silva, Cristiane Caldeira
author_facet da Silva, Cristiane Caldeira
Cruz, Mayara
Freitas, João Carlos
Presgrave, Octavio
Moraes, Aurea
Delgado, Isabella Fernandes
author_role author
author2 Cruz, Mayara
Freitas, João Carlos
Presgrave, Octavio
Moraes, Aurea
Delgado, Isabella Fernandes
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv da Silva, Cristiane Caldeira
Cruz, Mayara
Freitas, João Carlos
Presgrave, Octavio
Moraes, Aurea
Delgado, Isabella Fernandes
dc.subject.por.fl_str_mv Teste da Ativação de Monócitos
Teste de Pirogênios
Farmacopeias
Produtos Biológicos
Monocyte Activation Test
Rabbit Pyrogen Test
Pharmacopoeias
Biological products
topic Teste da Ativação de Monócitos
Teste de Pirogênios
Farmacopeias
Produtos Biológicos
Monocyte Activation Test
Rabbit Pyrogen Test
Pharmacopoeias
Biological products
description Monocyte Activation Test (MAT) is thought to be a good replacement for rabbit pyrogen test (RPT); however, MAT remains controversial. MAT was not adequately evaluated in a sufficient number of products, and there is no sufficient data that support the ability of MAT to detect non-endotoxin pyrogens. Furthermore, MAT was used subject to validation for each specific product. The aim of this study was to identify in main pharmacopoeias, whose monographs require pyrogenicity tests, and propose those products for which only the rabbit pyrogen test is required to be used as a kick-off study for future studies. Products’ monographs in pharmacopeias in the United States, Europe, and Brazil that are recommended for RPT or Bacterial Endotoxins Test (BET) are as follows. RPT: 20 in American, 37 in European, and 28 in Brazilian pharmacopoeias. BET: 619 in American, 157 in European, and 41 in Brazilian pharmacopoeias. Four products require pyrogenicity testing in three pharmacopoeias. Both RPT and BET are recommended by six monographs in Brazilian pharmacopeias and 15 in European pharmacopoeias. In Brazilian pharmacopoeias most are biological. These products should be the first to be tested for their applicability to MAT because they are currently tested mainly by RPT.
publishDate 2015
dc.date.none.fl_str_mv 2015-08-26
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/519
10.3395/2317-269x.00519
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/519
identifier_str_mv 10.3395/2317-269x.00519
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/519/242
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://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 Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 3 (2015): August; 41-46
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 3 (2015): Agosto; 41-46
Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 3 (2015): Agosto; 41-46
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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