Storage-stable fibrinogen solutions
OwnerChristopher Woolvertoninventor
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Abstract
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++).
Claims30
A storage-stable, concentrated, ready-to-use, biocompatible mammalian fibrinogen solution, wherein stability of the fibrinogen solution is pH and temperature dependent.
A method of stably storing mammalian fibrinogen in a ready-to-use, aqueous solution, comprising:
- preparing a freshly prepared fibrinogen solution or freshly isolating and purifying fibrinogen solution from plasma or from a frozen fibrinogen preparation under sterile conditions;
- and
- storing the fibrinogen solution at refrigeration temperature,
- wherein the fibrinogen solution remains liquid, and at pH levels ranging from pH 6.5 to 8.2, and under conditions wherein biocompatibility and biological activity of the fibrinogen is maintained.
A method of stably storing mammalian fibrinogen in a ready-to-use, aqueous solution, comprising:
- storing a freshly prepared or freshly isolated and purified fibrinogen solution or one prepared from a frozen fibrinogen preparation under sterile conditions, and
- maintaining the stored fibrinogen solution at room temperature temperature,
- wherein the fibrinogen solution remains liquid, and at pH levels ranging from pH 6.5 to 8.2, and under conditions wherein biocompatibility and biological activity of the fibrinogen is maintained.
A method of stably storing mammalian fibrinogen in a ready-to-use, aqueous solution, comprising:
- freshly preparing a fibrinogen solution, or freshly isolating and purifying a fibrinogen solution from plasma or from a frozen fibrinogen preparation under sterile conditions;
- adding to the fibrinogen solution an effective amount of a protease inhibitor to prevent proteolysis of the fibrinogen sample;
- and
- storing the fibrinogen solution at (i) a constant temperature ranging from about 4° C. to about 23° C., wherein the fibrinogen solution remains liquid;
- (ii) at pH levels ranging from pH 6.31 to 8.1, (iii) under conditions wherein biocompatibility and biological activity of the fibrinogen is maintained.
Dependencies are inferred from the claim text.