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Evaluation of an in vitro cell culture assay for the potency assessment of recombinant human erythropoietin.
Machado, Francine T; Maldaner, Fernanda P S; Perobelli, Rafaela F; Xavier, Bruna; da Silva, Francielle S; de Freitas, Guilherme W; Bartolini, Paolo; Ribela, M Tereza C P; Dalmora, Sérgio L.
Afiliação
  • Machado FT; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • Maldaner FP; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • Perobelli RF; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • Xavier B; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • da Silva FS; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • de Freitas GW; Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
  • Bartolini P; Biotechnology Department, IPEN-CNEN, São Paulo-SP, Brazil.
  • Ribela MT; Biotechnology Department, IPEN-CNEN, São Paulo-SP, Brazil.
  • Dalmora SL; Biotechnology Department, IPEN-CNEN, São Paulo-SP, Brazil.
Altern Lab Anim ; 44(2): 113-20, 2016 May.
Article em En | MEDLINE | ID: mdl-27256453
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.
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Eritropoetina / Técnicas de Cultura de Células Limite: Animals Idioma: En Revista: Altern Lab Anim Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Buscar no Google
Adicionar na Minha BVS
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PubMed Links

Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Eritropoetina / Técnicas de Cultura de Células Limite: Animals Idioma: En Revista: Altern Lab Anim Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido