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Altern Lab Anim ; 44(2): 113-20, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27256453

RESUMO

Recombinant human erythropoietin is a sialoglycoprotein that stimulates erythropoiesis. To assess potency of human erythropoietin produced by recombinant technology, we investigated an in vitro TF-1 cell proliferation assay, which was applied in conjunction with a reversed-phase liquid chromatography method for the determination of the content of sialic acids. The results obtained, which were higher than 126.8ng/µg, were compared with those obtained with the in vivo normocythaemic mouse bioassay. The in vitro assay resulted in a non-significant lower mean difference of the estimated potencies (0.61% ± 0.026, p > 0.05). The use of this combination of methods represents an advance toward the establishment of alternative in vitro approaches, in the context of the Three Rs, for the potency assessment of biotechnology-derived medicines.


Assuntos
Técnicas de Cultura de Células , Eritropoetina/farmacologia , Animais , Proliferação de Células/efeitos dos fármacos , Feminino , Camundongos , Camundongos Endogâmicos BALB C , Proteínas Recombinantes/farmacologia
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