Process for producing a virus-inactivated thrombin preparation

Details Process for producing a virus-inactivated thrombin preparation Process for producing a virus-inactivated thrombin preparation

C - Chemistry, Metallurgy

12

N

C12N 9/74 (2006.01) A61K 38/36 (2006.01) A61K 38/48 (2006.01) A61L 2/00 (2006.01) G01N 33/86 (2006.01)

Patent

CA 2491718

A method for the preparation of virus-inactivated thrombin comprising solvent- detergent virus inactivation of a solution comprising prothrombin and factor X, loading the virus inactivated prothrombin and factor X onto an anion exchange medium, washing the medium to remove the reagents used for the solvent-detergent virus inactivation, and activating the prothrombin on the medium to form thrombin by the addition of metal ions, preferably calcium ions. The thrombin is then preferably selectively eluted from the anion exchange medium.

Cette invention concerne une méthode de préparation d'une thrombine à virus inactivé. Cette méthode consiste à : inactiver un virus par solvant-détergent dans une solution comprenant une prothrombine et un facteur X; charger la prothrombine à virus inactivé et le facteur X sur un support d'échange anionique; laver le support pour faire disparaître les réactifs utilisés lors de l'inactivation du virus par solvant-détergent; et activer la prothrombine sur ce support pour former une thrombine par adjonction d'ions métal, de préférence d'ions calcium. Ensuite, il est préférable d'éluer sélectivement la thrombine à partir du support d'échange anionique.

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