Process for removing viruses in fibrinogen solutions and fibrinogen obtained by said process
AssigneeGrifols, S.A.
InventorsPere Ristol Debart, Jesus Fernandez Rodriguez
Life of this patent
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Abstract
A process for removing viruses in fibrinogen solutions and fibrinogen obtained thereof wherein the process starts with an adjusted purified fibrinogen solution, the adjusted purified solution is frozen and then thawed at a temperature between 5 and 20° C., the undissolved materials associated with the fibrinogen are subsequently separated, the temperature is adjusted and the resultant solution is finally subjected to nanofiltration using filters having a pore size smaller than 35 nm.
Claims16
A process for removing viruses in fibrinogen solutions for therapeutic application, comprising:
- (a) obtaining a fibrinogen solution originating from previously purified human plasma, with a purity greater than or equal to 80% of fibrinogen with respect to the total proteins;
- (b) stabilizing and freezing said fibrinogen solution and subsequent thawing thereof at a temperature between 5 and 20° C.;
- (c) separating the undissolved materials;
- (d) diluting the resultant protein solution;
- and
- (e) nanofiltration of the diluted solution through a filter having a pore size smaller than 35 nm;
- wherein the freezing, thawing and nanofiltration are carried out in the presence of at least one amino acid.
A process for removing viruses in fibrinogen solutions for therapeutic application, comprising:
- (a) obtaining a fibrinogen solution originating from previously purified human plasma, with a purity greater than or equal to 80% of fibrinogen with respect to the total proteins;
- (b) stabilizing and freezing said fibrinogen solution and subsequent thawing thereof at a temperature between 5 and 20° C.;
- (c) separating the undissolved materials;
- (d) obtaining an arginine solution;
- (e) diluting the resultant protein solution with the arginine solution;
- (f) nanofiltering the diluted solution through a first filter having a pore size of 50 nm;
- and
- (g) nanofiltering the diluted solution through a second filter having a pore size of 20 nm.
Dependencies are inferred from the claim text.