Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach

Detalhes bibliográficos
Autor(a) principal: Nascimento, Michele Cardoso do
Data de Publicação: 2015
Outros Autores: Abreu, Clarice Lima do Canto, Costa, Rodrigo Netto, Moura, Wlamir Corrêa de, Delgado, Isabella Fernandes
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/11845
http://dx.doi.org/10.1590/S1516-8913201500228
Resumo: Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.
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spelling Nascimento, Michele Cardoso doAbreu, Clarice Lima do CantoCosta, Rodrigo NettoMoura, Wlamir Corrêa deDelgado, Isabella Fernandes2015-09-29T17:06:10Z2015-09-29T17:06:10Z2015NASCIMENTO, M. C. et al. Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach. Braz. arch. biol. technol., Curitiba, v. 58, n. 4, p. 562-568, 2015.1678-4324https://www.arca.fiocruz.br/handle/icict/11845http://dx.doi.org/10.1590/S1516-8913201500228engInstituto de Tecnologia do ParanáEritropoetina Humana RecombinanteBiológicoControle de QualidadeVigilância SanitáriaRecombinant Human ErythropoietinBiologicalQuality ControlSanitary SurveillanceEritropoetinaControle de QualidadeVigilância SanitáriaPotency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approachinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Vice-Diretoria de Pesquisa, Ensino e Projetos Estratégicos. Rio de Janeiro, RJ, Brasil.In this study, we compared the results of potency determination of recombinant human erythropoietin (rhEPO) obtained between 2010 and 2012 by the National Institute of Quality Control in Health (INCQS/Fiocruz), i.e., the National Control Laboratory (NCL), and by a manufacturer of rhEPO. In total, 47 different batches of commercially prepared rhEPO (alpha isoform) were analyzed. All results, including those of the control and warning limits, remained within the limits recommended by European Pharmacopoeia (Ph. Eur.). All relative error (RE) values were less than ± 30%, wh ereas most were approximately ± 20%. Applying the Bland-Altman plot, only two of 47 values remained outside the limits of agreement (LA). In addition, agreement of potency determination between INCQS and the manufacturer coefficient of variation of reproducibility (% CVR) was considered satisfactory. Taken together, our results demonstrate (i.) the potency assay of rhEPO performed at INCQS, is standardized and controlled, (ii.) the comparison of our results with those of the manufacturer, revealed an adequate inter-laboratory variation, and (iii.) the critical appraisal proposed here appears to be a feasible tool to assess the reproducibility of biological activity, providing additional information regarding monitoring and production consistency to manufacturers and NCLs.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82354https://www.arca.fiocruz.br/bitstream/icict/11845/1/license.txt8b4c200b4e10021c5683c6ccaba07169MD51ORIGINAL1516-8913-babt-201500228.pdf1516-8913-babt-201500228.pdfapplication/pdf388486https://www.arca.fiocruz.br/bitstream/icict/11845/2/1516-8913-babt-201500228.pdfb1223f4400a8cce3ee05f0f7b21e38c6MD52TEXT1516-8913-babt-201500228.pdf.txt1516-8913-babt-201500228.pdf.txtExtracted texttext/plain30358https://www.arca.fiocruz.br/bitstream/icict/11845/3/1516-8913-babt-201500228.pdf.txt388c61e24bb84083115dddd347fb941fMD53icict/118452018-04-04 08:16:03.044oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352018-04-04T11:16:03Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.en.fl_str_mv Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
title Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
spellingShingle Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
Nascimento, Michele Cardoso do
Eritropoetina Humana Recombinante
Biológico
Controle de Qualidade
Vigilância Sanitária
Recombinant Human Erythropoietin
Biological
Quality Control
Sanitary Surveillance
Eritropoetina
Controle de Qualidade
Vigilância Sanitária
title_short Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
title_full Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
title_fullStr Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
title_full_unstemmed Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
title_sort Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
author Nascimento, Michele Cardoso do
author_facet Nascimento, Michele Cardoso do
Abreu, Clarice Lima do Canto
Costa, Rodrigo Netto
Moura, Wlamir Corrêa de
Delgado, Isabella Fernandes
author_role author
author2 Abreu, Clarice Lima do Canto
Costa, Rodrigo Netto
Moura, Wlamir Corrêa de
Delgado, Isabella Fernandes
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Nascimento, Michele Cardoso do
Abreu, Clarice Lima do Canto
Costa, Rodrigo Netto
Moura, Wlamir Corrêa de
Delgado, Isabella Fernandes
dc.subject.other.pt_BR.fl_str_mv Eritropoetina Humana Recombinante
Biológico
Controle de Qualidade
Vigilância Sanitária
topic Eritropoetina Humana Recombinante
Biológico
Controle de Qualidade
Vigilância Sanitária
Recombinant Human Erythropoietin
Biological
Quality Control
Sanitary Surveillance
Eritropoetina
Controle de Qualidade
Vigilância Sanitária
dc.subject.en.en.fl_str_mv Recombinant Human Erythropoietin
Biological
Quality Control
Sanitary Surveillance
dc.subject.decs.pt_BR.fl_str_mv Eritropoetina
Controle de Qualidade
Vigilância Sanitária
description Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil.
publishDate 2015
dc.date.accessioned.fl_str_mv 2015-09-29T17:06:10Z
dc.date.available.fl_str_mv 2015-09-29T17:06:10Z
dc.date.issued.fl_str_mv 2015
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv NASCIMENTO, M. C. et al. Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach. Braz. arch. biol. technol., Curitiba, v. 58, n. 4, p. 562-568, 2015.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/11845
dc.identifier.issn.none.fl_str_mv 1678-4324
dc.identifier.doi.none.fl_str_mv http://dx.doi.org/10.1590/S1516-8913201500228
identifier_str_mv NASCIMENTO, M. C. et al. Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach. Braz. arch. biol. technol., Curitiba, v. 58, n. 4, p. 562-568, 2015.
1678-4324
url https://www.arca.fiocruz.br/handle/icict/11845
http://dx.doi.org/10.1590/S1516-8913201500228
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Instituto de Tecnologia do Paraná
publisher.none.fl_str_mv Instituto de Tecnologia do Paraná
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/11845/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/11845/2/1516-8913-babt-201500228.pdf
https://www.arca.fiocruz.br/bitstream/icict/11845/3/1516-8913-babt-201500228.pdf.txt
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