Method for preparing by filtration a virally secure factor...

C - Chemistry – Metallurgy – 07 – K

Patent

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Details

C07K 14/755 (2006.01) A61K 38/37 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2314610

The invention concerns a method for preparing by filtration a virally secure factor VIII solution and essentially free of high molecular weight vWF which consists in: preparing a solution containing high or very high purity factor VIII or essentially free of complexes with VIII-vWf factor high molecular weight; optionally carrying out a step (a) if required, of chemical breakdown of the complexes with VIII-vWF factor high molecular weight and obtaining a solution essentially free of factor VIII associated with high molecular weight vWF; carrying out a step (b) filtering said solution essentially free of factor VIII associated with high molecular weight vWF on a hydrophilic filter with porosity as low as 15 nm.

La présente invention concerne un procédé de préparation par filtration d'une solution de facteur VIII sécurisée viralement et essentiellement dépourvue de vWF de haut poids moléculaire, selon lequel: on prépare une solution contenant du facteur VIII de haute ou très haute pureté contenant ou essentiellement dépourvue de complexes de haut poids moléculaire facteur VIII-vWF; on met en oeuvre de façon optionnelle, une étape a) permettant, si nécessaire, la dissociation des complexes de haut poids moléculaire facteur VIII-vWF et l'obtention d'une solution essentiellement dépourvue de facteur VIII associé à du vWF de haut poids moléculaire; on met en oeuvre une étape b) de filtration de ladite solution essentiellement dépourvue de facteur VIII associé à du vWF de haut poids moléculaire sur un filtre hydrophile ayant une porosité aussi faible que 15 nm.

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