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|Title:||Investigations into, and development of, a lyophilized and formulated recombinant human factor IX produced from CHO cells|
|Authors:||Almeida, Aline G.|
Pinto, Rodrigo C. V.
Smales, C. Mark
Castilho, Leda R.
|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.|
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.
|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.|
Recombinant factor IX
Fator IX recombinante
Estudo de estabilidade
Composição de Medicamentos
|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.|
|Appears in Collections:||Biomanguinhos - Artigos de Periódicos|
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