Process for the production of highly viral safe components...

C - Chemistry – Metallurgy – 07 – K

Patent

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Details

C07K 1/14 (2006.01) A61K 38/45 (2006.01) A61K 38/48 (2006.01) A61L 2/00 (2006.01) A61L 24/10 (2006.01) C07K 14/745 (2006.01) C12N 9/10 (2006.01) C12N 9/74 (2006.01)

Patent

CA 2307380

This invention relates to a process for preparing biological glue components from a plasma pool which combines high recovery, quality product and viral safety. In first instance, a triple viral inactivated product comprising fibrogen, fibronectin and FXIII is obtained by treating a concentrate thereof first with a viricide solvent/detergent solution, second with viral nanofiltration, and third with heat. The recovery of a good quality product is not compromised by the process of the invention. In second instance, the same steps are reproduced for obtaining a triple viral safe thrombin product. In that case, a known proprietary process has been improved to increase the recovery of active thrombin by about two fold.

L'invention concerne un procédé de préparation des composantes de colle biologique à partir d'un ensemble de plasma combinant une récupération élevée, un produit de qualité et une sécurité antivirale. En premier lieu, on obtient un triple produit inactivé viralement comprenant du fibrinogène, de la fibronectine et FXIII par traitement d'un concentré de celui-ci tout d'abord avec une solution virucide de solvant/détergent, deuxièmement par une nanofiltration virale et troisièmement à la chaleur. La récupération d'un produit de bonne qualité n'est pas compromise par le procédé de l'invention. En second lieu, on répète les mêmes étapes pour obtenir un triple produit à base de thrombine sans danger viral. Dans ce cas, on a amélioré un procédé breveté connu pour multiplier la thrombine active récupérée.

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