Claims for Patent: 6,399,357

Summary for Patent: 6,399,357

Title:	Filtration
Abstract:	Filtration methods comprise virus-filtering a solution containing at least one macromolecule. The total salt content of the solution is within the range of from about 0.2M to 2M or within the range of from about 0.2M up to saturation with the salt.
Inventor(s):	Winge; Stefan (Stockholm, SE)
Assignee:	Biovitrum AB (Stockholm, SE)
Application Number:	09/511,953
Patent Claims:	1. A filtration method comprising virus-filtering a solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of about 0.6 M to 2.0 M. 2. A method according to claim 1, wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, sodium acetate, sodium citrate, sodium phosphate, potassium dihydrophosphate and combinations thereof. 3. A method according to claim 1, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides, polypeptides, and combinations thereof. 4. A method according to claim 3, wherein the macromolecule is factor IX. 5. A method according to claim 3, wherein the macromolecule is gammaglobulin. 6. A method according to claim 3, wherein the macromolecule is albumin. 7. A method according to claim 3, wherein the macromolecule is antithrombin III. 8. A method according to claim 3, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 9. A method according to claim 1, wherein a non-lipid enveloped virus is removed from the solution. 10. A method according to claim 9, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 11. A method according to claim 9, wherein the virus-filtering step reduces the content of non-lipid enveloped viruses by at least 4 logs. 12. A method according to claim 1, wherein a lipid-enveloped virus is removed from the solution. 13. A method according to claim 12, wherein the lipid-enveloped virus is selected from the group consisting of hepatitis virus B, hepatitis virus C and the human immuno-deficiency virus (HIV). 14. A method according to claim 1, wherein a virus smaller than about 350 nm is removed from the solution. 15. A method according to claim 14, wherein the virus removed from the solution is smaller than 200 nm. 16. A method according to claim 15, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 17. A filtration method comprising virus-filtering a solution containing at least one macromolecule and at least one virus selected from the group consisting of hepatitis virus A, polio virus and parvo virus, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, sodium acetate, sodium citrate, sodium phosphate, potassium dihydrophosphate and combinations thereof. 18. A method according to claim 17, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides, polypeptides, and combinations thereof. 19. A method according to claim 17, wherein the macromolecule is factor IX. 20. A method according to claim 17, wherein the macromolecule is gammaglobulin. 21. A method according to claim 17, wherein the macromolecule is albumin. 22. A method according to claim 17, wherein the macromolecule is antithrombin III. 23. A method according to claim 17, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 24. A filtration method according to claim 17, wherein the total salt content of the solution is within the range of about 0.6 M to 1.5 M. 25. A filtration method comprising virus-filtering a solution containing at least one macromolecule and at least one virus selected from the group consisting of hepatitis virus A, polio virus and parvo virus, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the macromolecule is in solution during the virus filtering. 26. A method according to claim 25, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides, polypeptides, and combinations thereof. 27. A method according to claim 26, wherein the macromolecule is factor IX. 28. A method according to claim 26, wherein the macromolecule is gammaglobulin. 29. A method according to claim 26, wherein the macromolecule is albumin. 30. A method according to claim 26, wherein the macromolecule is antithrombin III. 31. A method according to claim 26, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 32. A filtration method according to claim 25, wherein the total salt content of the solution is within the range of about 0.6 M to 1.5 M. 33. A filtration method comprising virus-filtering a solution containing at least one macromolecule selected from the group consisting of factor VIII, factor IX, antithrombin III, human serum albumin, gammaglobulin, streptokinase, apolipoproteins, and growth hormones, wherein the total salt content of the solution is within the range of about 0.6 M to 2 M. 34. A method according to claim 33, wherein a non-lipid enveloped virus is removed from the solution. 35. A method according to claim 34, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 36. A method according to claim 33, wherein a lipid-enveloped virus is removed from the solution. 37. A method according to claim 36, wherein the lipid-enveloped virus is selected from the group consisting of hepatitis virus B, hepatitis virus C and the human immuno-deficiency virus (HIV). 38. A method according to claim 33, wherein a virus smaller than about 350 nm is removed from the solution. 39. A method according to claim 38, wherein the virus removed from the solution is smaller than 200 nm. 40. A method according to claim 39, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 41. A filtration method comprising virus-filtering a solution containing at least one macromolecule selected from the group consisting of factor VIII, factor IX, antithrombin III, human serum albumin, gammaglobulin, streptokinase, apolipoproteins, and growth hormones, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, sodium acetate, sodium citrate, sodium phosphate, potassium dihydrophosphate and combinations thereof. 42. A method according to claim 41, wherein a non-lipid enveloped virus is removed from the solution. 43. A method according to claim 42, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 44. A method according to claim 41, wherein a lipid-enveloped virus is removed from the solution. 45. A method according to claim 44, wherein the lipid-enveloped virus is selected from the group consisting of hepatitis virus B, hepatitis virus C and the human immuno-deficiency virus (HIV). 46. A method according to claim 41, wherein a virus smaller than about 350 nm is removed from the solution. 47. A method according to claim 46, wherein the virus removed from the solution is smaller than 200 nm. 48. A method according to claim 47, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 49. A filtration method comprising virus-filtering a solution containing at least one macromolecule selected from the group consisting of factor VIII, factor IX, antithrombin III, human serum albumin, gammaglobulin, streptokinase, apolipoproteins, and growth hormones, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the macromolecule is in solution during the virus filtering. 50. A method according to claim 49, wherein a non-lipid enveloped virus is removed from the solution. 51. A method according to claim 50, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 52. A method according to claim 49, wherein a lipid-enveloped virus is removed from the solution. 53. A method according to claim 52, wherein the lipid-enveloped virus is selected from the group consisting of hepatitis virus B, hepatitis virus C and the human immuno-deficiency virus (HIV). 54. A method according to claim 49, wherein a virus smaller than about 350 nm is removed from the solution. 55. A method according to claim 54, wherein the virus removed from the solution is smaller than 200 nm. 56. A method according to claim 55, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 57. A method for obtaining parvo virus, comprising filtering a solution containing a parvo virus, at least one macromolecule, and a salt, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the macromolecule is in solution during the filtering step. 58. A method for obtaining polio virus comprising filtering a solution containing a polio virus, at least one macromolecule, and a salt, wherein the total salt content of the solution is within the range of about 0.6 M up to saturation, and wherein the macromolecule is in solution during the filtering step. 59. A filtration method comprising virus-filtering a solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of about 0.6 M to 2 M, and wherein the virus-filtering step employs dead-end filtration.

Details for Patent 6,399,357

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	THROMBATE III	antithrombin iii (human)	For Injection	103196	12/30/1991		2014-06-23