Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/11845
Title: Potency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
Authors: Nascimento, Michele Cardoso do
Abreu, Clarice Lima do Canto
Costa, Rodrigo Netto
Moura, Wlamir Corrêa de
Delgado, Isabella Fernandes
Affilliation: 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. 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.
Abstract: 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.
Keywords: Recombinant Human Erythropoietin
Biological
Quality Control
Sanitary Surveillance
keywords: Eritropoetina Humana Recombinante
Biológico
Controle de Qualidade
Vigilância Sanitária
DeCS: Eritropoetina
Controle de Qualidade
Vigilância Sanitária
Issue Date: 2015
Publisher: Instituto de Tecnologia do Paraná
Citation: 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.
DOI: http://dx.doi.org/10.1590/S1516-8913201500228
ISSN: 1678-4324
Copyright: open access
Appears in Collections:INCQS - Artigos de Periódicos

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