Author | Almeida, Aline G. | |
Author | Pinto, Rodrigo C. V. | |
Author | Smales, C. Mark | |
Author | Castilho, Leda R. | |
Access date | 2018-05-10T18:51:54Z | |
Available date | 2018-05-10T18:51:54Z | |
Document date | 2017 | |
Citation | 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. | pt_BR |
ISSN | 0141-5492 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/26401 | |
Language | por | pt_BR |
Rights | open access | pt_BR |
Subject in Portuguese | Excipientes | pt_BR |
Subject in Portuguese | Formulação | pt_BR |
Subject in Portuguese | Congelamento | pt_BR |
Subject in Portuguese | Liofilização | pt_BR |
Subject in Portuguese | Fator IX recombinante | pt_BR |
Subject in Portuguese | Estudo de estabilidade | pt_BR |
Title | Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells | pt_BR |
Type | Article | pt_BR |
Abstract | 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. | pt_BR |
Affilliation | 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. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil. | pt_BR |
Affilliation | University of Kent at Canterbury. Industrial Biotechnology Centre and School of Biosciences. Canterbury, NJ, United Kingdom. | pt_BR |
Subject | Excipients | pt_BR |
Subject | Formulation | pt_BR |
Subject | Freezedrying | pt_BR |
Subject | Lyophilization | pt_BR |
Subject | Recombinant factor IX | pt_BR |
Subject | Stability study | pt_BR |
DeCS | Excipientes | pt_BR |
DeCS | Composição de Medicamentos | pt_BR |
DeCS | Congelamento | pt_BR |
DeCS | Liofilização | pt_BR |
e-ISSN | 1573-6776 | |