Storage-stable human fibrinogen solutions

A - Human Necessities – 61 – K

Patent

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Details

A61K 35/16 (2006.01) A61K 38/36 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01) A61L 24/10 (2006.01)

Patent

CA 2462596

Methods are provided for the stable storage of ready-to-use, biocompatible human fibrinogen, which despite its concentration, remains available in fluid form, and which will permit long-term rapid and easy processing into a tissue adhesive preparation. Also provided is the sterile, storage-stable aqueous fibrinogen product resulting from the use of the present methods, wherein the fibrinogen remains long term in ready-to-use in liquid form, it has not spontaneously clotted (i.e., formed a clot even in the absence of an activator, such as thrombin/Ca++), and it retains its biological activity (i.e., the ability to rapidly form a fibrin clot upon exposure and vigorous mixing with thrombin and Ca++).

L'invention concerne des procédés de stockage stable d'un fibrinogène humain biocompatible prêt à l'emploi, lequel, en dépit de sa concentration, conserve sa forme fluide. Ce fibrinogène humain permet une utilisation simple, rapide et à long terme dans une préparation d'adhérence tissulaire. Cette invention concerne également un produit de fibrinogène aqueux stérile, stable au stockage obtenu grâce aux procédés décrits dans cette invention. Le fibrinogène reste longtemps prêt à l'emploi sous une forme liquide, il ne se coagule pas spontanément (c'est-à-dire qu'il ne forme pas de caillot spontanément, même en l'absence d'un activateur, tel que la thrombine/Ca?++¿), et il conserve son activité biologique (c'est-à-dire, son aptitude à former rapidement un caillot de fibrine après exposition puis mélange énergique avec une thrombine et du Ca?++¿).

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