Storage-stable fibrinogen solutions

A - Human Necessities – 61 – K

Patent

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Details

A61K 35/14 (2006.01) A61K 35/16 (2006.01) A61K 38/00 (2006.01) A61K 38/36 (2006.01) A61L 24/10 (2006.01) C07K 1/00 (2006.01)

Patent

CA 2462599

Methods are provided for the stable storage of ready-to-use, biocompatible mammalian 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 mammifère biocompatible prêt à l'emploi, lequel, en dépit de sa concentration, conserve une forme fluide et permet une utilisation simple, rapide à long terme dans une préparation d'adhérence tissulaire. L'invention concerne également un produit de fibrinogène aqueux stérile et 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 spontanément de caillot 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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