IP Library › Granted Patent US 8,354,505
Granted Patent B2
US 8,354,505 · App. 12/349,604 · Granted Jan 15, 2013

Process for obtaining a concentrate of Von Willebrand factor or a complex of factor VII/Von Willebrand factor and use of the same

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Quick Facts
Patent No.
US 8,354,505
App. No.
12/349,604
Filed
Jan 7, 2009
Granted
Jan 15, 2013
Kind
B2
Art Unit
1656
USPC
514/14.1
Abstract

A concentrate of Von Willebrand Factor (VWF) or a complex of Factor VIII/VWF is prepared by creating a solution of VWF or a complex of Factor VIII/VWF containing VWF at a concentration of up to 12 IU VWF:RCo/ml and a VWF/Factor VIII ratio of 0.4 or more; and nanofiltering that starting solution through a filter of pore size of 35 nanometers or smaller. The resulting VWF retains high molecular weight multimers.

Claims (14)

1. A process for obtaining a concentrate of a Factor VIII/Von Willebrand Factor (VWF) complex of human or recombinant origin, said process comprising:

a) preparing a solution of a Factor VIII/Von Willebrand Factor complex which contains Von Willebrand Factor in a concentration of up to 12 IU VWF:RCo/ml and has a VWF:RCo/Factor VIII activity ratio of 0.4 to 3,

b) a nanofiltration step consisting of filtering the solution prepared in a) through a nanofilter having pore sizes of less than 35 nanometers, at a maximum pressure of less than or equal to 0.5 bar, in the presence of calcium ion at a concentration between 0.05 and 0.14 M, and at a pH greater than 5.5;

and thereby obtaining a concentrate of Factor VIII/VWF complex, wherein the VWF:RCo/Factor VIII activity ratio is not affected.

2. A process according to claim 1 , wherein the Von Willebrand Factor recovered after nanofiltration maintains a multimer structure which includes multimers of the order of 11 or more.

3. A process according to claim 1 , wherein the yield of recovered Von Willebrand Factor after nanofiltration is 60% or more.

4. A process according to claim 1 , wherein the yield of recovered Von Willebrand Factor after nanofiltration is 70% or more.

5. A process according to claim 1 , wherein a loading ratio of up to 50 IU of Von Willebrand Factor per cm 2 of filtering surface area is used.

6. A process according to claim 1 , wherein the maximum concentration of the solution being filtered is 0.6 AU (OD 280 ).

7. A process according to claim 1 , wherein the nanofiltration is carried out at a pressure of between 0.2 and 0.4 bar.

8. A process according to claim 1 , wherein the standard nanofiltration flow is between 10 and 20 liters/hour/m 2 .

9. A process according to claim 1 , wherein the nanofiltration is carried out using a nanofilter having pore sizes of 20 nanometers or less.

10. A process according to claim 1 , wherein the nanofiltration is carried out using a nanofilter having pore sizes of 19±1 nanometers.

11. A process according to claim 1 , wherein the recovered concentrate of Factor VIII/VWF complex has a VWF:RCo/Factor VIII activity ratio of at least 80% of that of the solution prepared in a).