Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2017 |
| Outros Autores: | , , |
| Tipo de documento: | Artigo |
| Idioma: | por |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/26401 |
Resumo: | Universidade Federal do Rio de Janeiro. Instituto Alberto Luiz Coimbra de Pós-Graduação e Pesquisa de Engenharia. Programa de Engenharia Quimica. Laboratório de Engenharia de Cultivos Celulares. Rio de Janeiro, RJ, Brasil. / Universidade Federal do Rio de Janeiro. Programa de Bioquímica. Rio de Janeiro, RJ, Brasil. |
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Almeida, Aline G.Pinto, Rodrigo C. V.Smales, C. MarkCastilho, Leda R.2018-05-10T18:51:54Z2018-05-10T18:51:54Z2017ALMEIDA, A. G; PINTO, R. C. V.; SMALES, C. M.; CASTILHO, L. R. Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells. Biotechnology Letters, v. 39, n. 8, p. 1109-1120, aug. 2017.0141-5492https://www.arca.fiocruz.br/handle/icict/264011573-6776porExcipientesFormulaçãoCongelamentoLiofilizaçãoFator IX recombinanteEstudo de estabilidadeExcipientsFormulationFreezedryingLyophilizationRecombinant factor IXStability studyExcipientesComposição de MedicamentosCongelamentoLiofilizaçãoInvestigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cellsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversidade Federal do Rio de Janeiro. Instituto Alberto Luiz Coimbra de Pós-Graduação e Pesquisa de Engenharia. Programa de Engenharia Quimica. Laboratório de Engenharia de Cultivos Celulares. Rio de Janeiro, RJ, Brasil. / Universidade Federal do Rio de Janeiro. Programa de Bioquímica. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.University of Kent at Canterbury. Industrial Biotechnology Centre and School of Biosciences. Canterbury, NJ, United Kingdom.Objectives: To develop a recombinant human factor IX (rFIX) formulation equivalent to commercially available products in terms of cake appearance, residual moisture, proportion of soluble aggregates and activity maintenance for 3 months at 4–8 ºC. Results: NaCl and low bulking agent/cryoprotectant mass ratio had a negative impact on cake quality upon lyophilisation for a wide range of formulations tested. Particular devised formulations maintained rFIX activity after lyophilization with a similar performance when compared with the rFIX formulated using the excipients reported for a commercially available FIX formulation (Benefix). rFIX remained active after 3 months when stored at 4 ºC, though this was not the case with samples stored at 40 ºC. Interestingly, particular formulations had an increase in residual moisture after 3 months storage, but not above a 3% threshold. All four formulations tested were equivalent to the Benefix formulation in terms of particle size distribution and cake appearance. Conclusions: Three specific formulations, consisting of surfactant polysorbate-80, sucrose or trehalose as cryoprotectant, mannitol or glycine as bulking agent, L-histidine as buffering agent, and NaCl added in the reconstitution liquid at 0.234% (w/v) were suitable for use with a CHO cell-derived recombinant FIX.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/26401/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALAlmeida 2017 Investigations into and development of a lyophilized and formulated recombinant human factor IX produced from CHO cells.pdfAlmeida 2017 Investigations into and development of a lyophilized and formulated recombinant human factor IX produced from CHO cells.pdfapplication/pdf1189084https://www.arca.fiocruz.br/bitstream/icict/26401/2/Almeida%202017%20Investigations%20into%20and%20development%20of%20a%20lyophilized%20and%20formulated%20recombinant%20human%20factor%20IX%20produced%20from%20CHO%20cells.pdff2ce732ef48a88ecf7065dc580e3fab5MD52TEXTAlmeida 2017 Investigations into and development of a lyophilized and formulated recombinant human factor IX produced from CHO cells.pdf.txtAlmeida 2017 Investigations into and development of a lyophilized and formulated recombinant human factor IX produced from CHO cells.pdf.txtExtracted texttext/plain35056https://www.arca.fiocruz.br/bitstream/icict/26401/3/Almeida%202017%20Investigations%20into%20and%20development%20of%20a%20lyophilized%20and%20formulated%20recombinant%20human%20factor%20IX%20produced%20from%20CHO%20cells.pdf.txt04c3d88e4ee6593a627ee7f6d597c67cMD53icict/264012018-08-15 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| dc.title.pt_BR.fl_str_mv |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| title |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| spellingShingle |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells Almeida, Aline G. Excipientes Formulação Congelamento Liofilização Fator IX recombinante Estudo de estabilidade Excipients Formulation Freezedrying Lyophilization Recombinant factor IX Stability study Excipientes Composição de Medicamentos Congelamento Liofilização |
| title_short |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| title_full |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| title_fullStr |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| title_full_unstemmed |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| title_sort |
Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells |
| author |
Almeida, Aline G. |
| author_facet |
Almeida, Aline G. Pinto, Rodrigo C. V. Smales, C. Mark Castilho, Leda R. |
| author_role |
author |
| author2 |
Pinto, Rodrigo C. V. Smales, C. Mark Castilho, Leda R. |
| author2_role |
author author author |
| dc.contributor.author.fl_str_mv |
Almeida, Aline G. Pinto, Rodrigo C. V. Smales, C. Mark Castilho, Leda R. |
| dc.subject.other.pt_BR.fl_str_mv |
Excipientes Formulação Congelamento Liofilização Fator IX recombinante Estudo de estabilidade |
| topic |
Excipientes Formulação Congelamento Liofilização Fator IX recombinante Estudo de estabilidade Excipients Formulation Freezedrying Lyophilization Recombinant factor IX Stability study Excipientes Composição de Medicamentos Congelamento Liofilização |
| dc.subject.en.pt_BR.fl_str_mv |
Excipients Formulation Freezedrying Lyophilization Recombinant factor IX Stability study |
| dc.subject.decs.pt_BR.fl_str_mv |
Excipientes Composição de Medicamentos Congelamento Liofilização |
| description |
Universidade Federal do Rio de Janeiro. Instituto Alberto Luiz Coimbra de Pós-Graduação e Pesquisa de Engenharia. Programa de Engenharia Quimica. Laboratório de Engenharia de Cultivos Celulares. Rio de Janeiro, RJ, Brasil. / Universidade Federal do Rio de Janeiro. Programa de Bioquímica. Rio de Janeiro, RJ, Brasil. |
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2017 |
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2017 |
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2018-05-10T18:51:54Z |
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2018-05-10T18:51:54Z |
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ALMEIDA, A. G; PINTO, R. C. V.; SMALES, C. M.; CASTILHO, L. R. Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells. Biotechnology Letters, v. 39, n. 8, p. 1109-1120, aug. 2017. |
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https://www.arca.fiocruz.br/handle/icict/26401 |
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0141-5492 |
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1573-6776 |
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ALMEIDA, A. G; PINTO, R. C. V.; SMALES, C. M.; CASTILHO, L. R. Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells. Biotechnology Letters, v. 39, n. 8, p. 1109-1120, aug. 2017. 0141-5492 1573-6776 |
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