STABLE LIQUID FIBRINOGEN
Disclosed is a composition including stable fibrinogen in liquid form.
1 - 22 . (canceled)
23 . Composition comprising stable fibrinogen in liquid form, wherein said composition has a coagulable fibrinogen/fibrinogen antigen ratio higher than 0.5.
24 . Composition according to claim 23 , wherein said composition is stable for at least 3 months at 4° C.
25 . Composition according to claim 23 , wherein said composition has a quantity of fibrinogen monomers retained during stability testing higher than 50% of the initial rate of fibrinogen monomers.
26 . Composition according to claim 23 , wherein said composition has a quantity of polymers formed during stability testing lower than 10% of the initial rate of fibrinogen polymers.
27 . Composition according to claim 23 , wherein:
all of the alpha chains are retained at at least 50%, and/or
all of the beta chains are retained at at least 50%, and/or
all of the gamma chains are retained at at least 50%.
28 . Composition according to claim 23 , wherein the turbidity measured after the stability test is lower than 130% of the turbidity measured before the stability test.
29 . Composition according to claim 23 , wherein said composition is devoid of proteases and/or of activators of fibrinolysis.
30 . Composition according to claim 23 , wherein said composition is devoid of protease inhibitors and/or of anti-fibrinolytics.
31 . Composition according to claim 23 , wherein said composition further comprises pharmaceutically acceptable excipients.
32 . Composition according to claim 23 , wherein said pharmaceutically acceptable excipients consist of arginine and of citrate.
33 . Composition according to claim 23 , constituted of fibrinogen, arginine and citrate.
34 . Composition according to claim 23 , wherein the composition is devoid of isoleucine and/or of glycine.
35 . Composition according to claim 23 , wherein the composition is devoid of albumin.
36 . Composition according to claim 23 , wherein the composition is devoid of metal ions, in particular calcium.
37 . Composition comprising fibrinogen according to claim 23 , said composition not having been subjected to any prior step of freeze-drying, desiccation, dehydration or drying.
38 . Composition comprising fibrinogen according to claim 23 , said composition not having been subjected to any prior step of reconstitution of a lyophilisate.
39 . Composition comprising fibrinogen according to claim 23 , able to be obtained by the method comprising the following steps:
a step of purification by affinity chromatography,
at least one step of biological security, and
a step of formulation in liquid form.
40 . Composition according to claim 39 , wherein the affinity chromatography consists of chromatography using ligands type moiety derived from llama antibody or aptamers.
41 . Composition comprising fibrinogen according to claim 23 able to be obtained according to the method comprising the following steps:
purification of a plasma or of a cryosupernatant fraction of blood plasma by separation by affinity gel chromatography,
recovery of the purified absorbed fraction comprising fibrinogen,
adding pharmaceutically acceptable excipients.
42 . Composition according to claim 23 for use in therapy.
43 . Composition for use according to claim 42 , wherein said composition is suitable for being administered intravenously.