A process for viral inactivation of lyophilized blood proteins

Details A process for viral inactivation of lyophilized blood proteins A process for viral inactivation of lyophilized blood proteins

C - Chemistry, Metallurgy

12

N

C12N 7/04 (2006.01) A61K 35/14 (2006.01) A61K 38/37 (2006.01) A61K 47/40 (2006.01) A61L 2/04 (2006.01)

Patent

CA 2252374

A process for the viral inactivation of lyophilized blood proteins, particularly Factor VIII, by heat comprising forming a stable complex between the blood protein and a cyclodextrin in an aqueous solution. The solution is then lyophilized and the blood protein/cyclodextrin complex is recovered. The lyophilized blood protein/cyclodextrin is then heated, e.g., to 80 °C for 72 hours, to inactivate any virus present. The material may then be reconstituted prior to administration to a patient.

Procédé d'inactivation de virus dans des protéines sanguines lyophilisées, en particulier le Facteur VIII, au moyen de la chaleur, consistant à former un complexe stable entre la protéine sanguine et une cyclodextrine dans une solution aqueuse. La solution est ensuite lyophilisée et le complexe protéine sanguine/cyclodextrine récupéré. Ce complexe lyophilisé est ensuite chauffé, par exemple à 80 DEG C pendant 72 heures, afin d'inactiver tout virus présent. La substance peut ensuite être reconstituée avant d'être administrée à un patient.

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