Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control
Autor(a) principal: | |
---|---|
Data de Publicação: | 2022 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055 |
Resumo: | Introduction: Accidents with venomous animals are classified as neglected tropical diseases and are currently the most frequent cause of intoxication in humans in Brazil. The only available treatment is the rapid administration of specific, quality-assured antivenoms. To ensure the efficacy and safety of these products, in vivo potency determination tests for venom and antivenom are performed during the production stages, until final release. Despite several studies on alternative methods to the murine assay, no method has been effectively validated. Objective: To compile alternative methods developed for Bothrops antivenoms, assessing the availability of the methods and the prospects and applications in Bothrops venom and antivenom production and quality control laboratories. Method: A search was conducted in PubMed, BVS, and Scopus databases between November 2021 and June 2022. 89 articles were identified, of which 31 were selected according to the eligibility criteria. Results: We observed in the alternative methods identified a preference of 42.80% of the studies for methodologies that use cell lines as an alternative method to the murine assays, and most of these works (58.30%) opted for a VERO cell line. Conclusions: Due to the diversity of toxins found in each genus of snakes, it is understood that the potency assay for antivenoms should be based on the evaluation and precise quantification of the inhibition of biological activity of venoms. Cytotoxicity assays are widely used and have been accumulating evidence of their suitability as an important alternative tool to the murine assay for quality control for Bothrops venom and antivenom. |
id |
FIOCRUZ-9_46e72ebc92479286914e2620a9bd45f4 |
---|---|
oai_identifier_str |
oai:ojs.visaemdebate.incqs.fiocruz.br:article/2055 |
network_acronym_str |
FIOCRUZ-9 |
network_name_str |
Vigilância Sanitária em Debate |
repository_id_str |
|
spelling |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality controlMétodos alternativos para determinação da potência de veneno e antiveneno botrópico: aplicações e perspectivas para o controle da qualidadeMétodos AlternativosVeneno BotrópicoAntiveneno BotrópicoControle da QualidadeMétodo alternativo para controle da qualidade para veneno e antiveneno botrópico.Alternative MethodsBothrops VenomBothrops AntivenomQuality ControlIntroduction: Accidents with venomous animals are classified as neglected tropical diseases and are currently the most frequent cause of intoxication in humans in Brazil. The only available treatment is the rapid administration of specific, quality-assured antivenoms. To ensure the efficacy and safety of these products, in vivo potency determination tests for venom and antivenom are performed during the production stages, until final release. Despite several studies on alternative methods to the murine assay, no method has been effectively validated. Objective: To compile alternative methods developed for Bothrops antivenoms, assessing the availability of the methods and the prospects and applications in Bothrops venom and antivenom production and quality control laboratories. Method: A search was conducted in PubMed, BVS, and Scopus databases between November 2021 and June 2022. 89 articles were identified, of which 31 were selected according to the eligibility criteria. Results: We observed in the alternative methods identified a preference of 42.80% of the studies for methodologies that use cell lines as an alternative method to the murine assays, and most of these works (58.30%) opted for a VERO cell line. Conclusions: Due to the diversity of toxins found in each genus of snakes, it is understood that the potency assay for antivenoms should be based on the evaluation and precise quantification of the inhibition of biological activity of venoms. Cytotoxicity assays are widely used and have been accumulating evidence of their suitability as an important alternative tool to the murine assay for quality control for Bothrops venom and antivenom.Introdução: Acidentes com animais peçonhentos são classificados como doenças tropicais negligenciadas e são atualmente a mais frequente causa de intoxicação em humanos no Brasil. O único tratamento disponível é a rápida administração de antivenenos específicos e de qualidade garantida. Para assegurar a eficácia e a segurança desses produtos, são realizados ensaios de determinação da potência in vivo para veneno e antiveneno, desde as etapas de produção até sua liberação final. Apesar dos diversos estudos sobre métodos alternativos ao ensaio murino, nenhum método foi efetivamente validado. Objetivo: Compilar os métodos alternativos desenvolvidos para os antivenenos botrópicos, avaliando sua disponibilidade, perspectivas e aplicações em laboratórios de produção e controle da qualidade. Método: Foi realizada uma busca nas bases PubMed, BVS e Scopus entre novembro de 2021 e junho de 2022. Foram identificados 89 trabalhos, dos quais 31 foram selecionados de acordo com os critérios de elegibilidade. Resultados: Nos métodos alternativos identificados, observamos a preferência de 42,80% dos estudos por metodologias que utilizem linhagens celulares como método alternativo aos ensaios murinos, sendo que a maioria destes trabalhos 58,30% optou pela linhagem celular Vero. Conclusões: Pela diversidade das toxinas encontradas em cada gênero de serpentes, entende-se que é de extrema importância que o ensaio de potência dos antivenenos tenha como base a avaliação e a quantificação precisa da inibição da atividade biológica dos venenos. Ensaios de citotoxicidade são amplamente utilizados e têm acumulado evidências de sua adequação como importante ferramenta alternativa ao ensaio murino para o controle da qualidade de veneno e antiveneno antibotrópico.Instituto Nacional de Controle de Qualidade em Saúde2022-08-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/205510.22239/2317-269x.02055Health Surveillance under Debate: Society, Science & Technology ; Vol. 10 No. 3 (2022): August; 106-121Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 3 (2022): Agosto; 106-121Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 3 (2022): Agosto; 106-1212317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055/1447https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055/1474Copyright (c) 2022 Renata Norbert Costa Nundes, Isabella Fernandes Delgado, Humberto Pinheiro de Araújo, Marcelo Salabert Gonzalez, Octavio Augusto França Presgrave, Wlamir Moura, Gutembert Gomes Alveshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessNundes, Renata Norbert CostaAraújo, Humberto Pinheiro deAlves, Gutemberg GomesDelgado, Isabella FernandesPresgrave, Octavio Augusto FrançaMoura, Wlamir Corrêa deGonzalez, Marcelo Salabert2023-06-27T15:15:33Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2055Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:15:33Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control Métodos alternativos para determinação da potência de veneno e antiveneno botrópico: aplicações e perspectivas para o controle da qualidade |
title |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
spellingShingle |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control Nundes, Renata Norbert Costa Métodos Alternativos Veneno Botrópico Antiveneno Botrópico Controle da Qualidade Método alternativo para controle da qualidade para veneno e antiveneno botrópico. Alternative Methods Bothrops Venom Bothrops Antivenom Quality Control |
title_short |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
title_full |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
title_fullStr |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
title_full_unstemmed |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
title_sort |
Alternative methods for potency evaluation for Bothrops venom and antivenom: applications and perspectives for quality control |
author |
Nundes, Renata Norbert Costa |
author_facet |
Nundes, Renata Norbert Costa Araújo, Humberto Pinheiro de Alves, Gutemberg Gomes Delgado, Isabella Fernandes Presgrave, Octavio Augusto França Moura, Wlamir Corrêa de Gonzalez, Marcelo Salabert |
author_role |
author |
author2 |
Araújo, Humberto Pinheiro de Alves, Gutemberg Gomes Delgado, Isabella Fernandes Presgrave, Octavio Augusto França Moura, Wlamir Corrêa de Gonzalez, Marcelo Salabert |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Nundes, Renata Norbert Costa Araújo, Humberto Pinheiro de Alves, Gutemberg Gomes Delgado, Isabella Fernandes Presgrave, Octavio Augusto França Moura, Wlamir Corrêa de Gonzalez, Marcelo Salabert |
dc.subject.por.fl_str_mv |
Métodos Alternativos Veneno Botrópico Antiveneno Botrópico Controle da Qualidade Método alternativo para controle da qualidade para veneno e antiveneno botrópico. Alternative Methods Bothrops Venom Bothrops Antivenom Quality Control |
topic |
Métodos Alternativos Veneno Botrópico Antiveneno Botrópico Controle da Qualidade Método alternativo para controle da qualidade para veneno e antiveneno botrópico. Alternative Methods Bothrops Venom Bothrops Antivenom Quality Control |
description |
Introduction: Accidents with venomous animals are classified as neglected tropical diseases and are currently the most frequent cause of intoxication in humans in Brazil. The only available treatment is the rapid administration of specific, quality-assured antivenoms. To ensure the efficacy and safety of these products, in vivo potency determination tests for venom and antivenom are performed during the production stages, until final release. Despite several studies on alternative methods to the murine assay, no method has been effectively validated. Objective: To compile alternative methods developed for Bothrops antivenoms, assessing the availability of the methods and the prospects and applications in Bothrops venom and antivenom production and quality control laboratories. Method: A search was conducted in PubMed, BVS, and Scopus databases between November 2021 and June 2022. 89 articles were identified, of which 31 were selected according to the eligibility criteria. Results: We observed in the alternative methods identified a preference of 42.80% of the studies for methodologies that use cell lines as an alternative method to the murine assays, and most of these works (58.30%) opted for a VERO cell line. Conclusions: Due to the diversity of toxins found in each genus of snakes, it is understood that the potency assay for antivenoms should be based on the evaluation and precise quantification of the inhibition of biological activity of venoms. Cytotoxicity assays are widely used and have been accumulating evidence of their suitability as an important alternative tool to the murine assay for quality control for Bothrops venom and antivenom. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-08-31 |
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/2055 10.22239/2317-269x.02055 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055 |
identifier_str_mv |
10.22239/2317-269x.02055 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055/1447 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2055/1474 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf 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. 10 No. 3 (2022): August; 106-121 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 10 Núm. 3 (2022): Agosto; 106-121 Vigil Sanit Debate, Rio de Janeiro; v. 10 n. 3 (2022): Agosto; 106-121 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 |
_version_ |
1797042046678073344 |