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

dc.creatorNascimento, Michele Cardoso do
dc.creatorAbreu, Clarice Lima do Canto
dc.creatorCosta, Rodrigo Netto
dc.creatorMoura, Wlamir Corrêa de
dc.creatorDelgado, Isabella Fernandes
dc.date2015-09-29T17:06:10Z
dc.date2015-09-29T17:06:10Z
dc.date2015
dc.date.accessioned2023-09-26T23:46:52Z
dc.date.available2023-09-26T23:46:52Z
dc.identifierNASCIMENTO, 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.identifier1678-4324
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/11845
dc.identifierhttp://dx.doi.org/10.1590/S1516-8913201500228
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8894137
dc.descriptionIn 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherInstituto de Tecnologia do Paraná
dc.rightsopen access
dc.subjectEritropoetina Humana Recombinante
dc.subjectBiológico
dc.subjectControle de Qualidade
dc.subjectVigilância Sanitária
dc.subjectRecombinant Human Erythropoietin
dc.subjectBiological
dc.subjectQuality Control
dc.subjectSanitary Surveillance
dc.subjectEritropoetina
dc.subjectControle de Qualidade
dc.subjectVigilância Sanitária
dc.titlePotency evaluation of recombinant human erythropoietin in Brazil: assessment of reproducibility using a practical approach
dc.typeArticle


Este ítem pertenece a la siguiente institución