Claims for Patent: 6,486,306

Summary for Patent: 6,486,306

Title:	Filtration
Abstract:	Filtration methods comprise virus-filtering a solution containing a least one macromolecule. In one embodiment, the total salt content of the solution is within the range of from about 0.2 M to 2 M. In another embodiment, the total salt content of the solution is within the range of from about 0.2 M up to saturation with a salt, and the salt is selected from the group consisting of sodium chloride, potassium chloride, sodium acetate, sodium citrate, sodium phosphate, potassium dyhydrophosphate and combinations thereof. In yet another embodiment, the total salt content of the solution is within the range of from about 0.2 M up to saturation with the salt and the macromolecule is in solution during the virus filtering.
Inventor(s):	Winge; Stefan (Stockholm, SE)
Assignee:	Biovitrum AB (Stockholm, SE)
Application Number:	08/750,664
Patent Claims:	1. A filtration method for removing at least one virus selected from the group consisting of hepatitis virus A, polio virus and parvo virus from a solution containing at least one macromolecule, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M to 2 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 2, wherein the macromolecule is selected form the group consisting of proteins, polycharides and polypeptides and combinations thereof. 4. A method according to claim 1, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides and polypeptides and combinations thereof. 5. A method according to claim 4, wherein the macromolecule is factor IX. 6. A method according to claim 4, wherein the macromolecule is gammaglobulin. 7. A method according to claim 4, wherein the macromolecule is albumin. 8. A method according to claim 6, wherein the macromolecule is antithrombin III. 9. A method according to claim 4, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 10. A method according to claim 1, wherein the virus-filtering step reduces the content of non-enveloped viruses by at least 4 logs. 11. A filtration method according to claim 1, wherein the total salt content of the solution is within the range of from about 0.2 M to 1.5 M. 12. A filtration method for removing at least one virus selected from the group consisting of hepatitis virus A, polio virus and parvo virus from a solution containing at least one macromolecule, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation with the salt, 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. 13. A method according to claim 12, wherein the total salt content of the solution is within the range of from 0.4 M to 2.0 M. 14. A method according to claim 12, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides and polypeptides and combinations thereof. 15. A method according to claim 14, wherein the macromolecule is factor IX. 16. A method according to claim 14, wherein the macromolecule is gammaglobulin. 17. A method according to claim 14, wherein the macromolecule is albumin. 18. A method according to claim 14, wherein the macromolecule is antithrombin III. 19. A method according to claim 14, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 20. A filtration method according to claim 12, wherein the total salt content of the solution is within the range of from about 0.2 M to 1.5 M. 21. A filtration method for removing at least one virus selected from the group consisting of hepatitis virus A, polio virus and parvo virus from a solution containing at least one macromolecule, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation with the salt, and wherein the macromolecule is in solution during the virus filtering. 22. A method according to claim 21, wherein the total salt content of the solution is within the range of from 0.6 to 2.0 M. 23. A method according to claim 21, wherein the virus-filtering step comprises dead-end filtration. 24. A method according to claim 21, wherein the macromolecule is selected from the group consisting of proteins, polysaccharides and polypeptides and combinations thereof. 25. A method according to claim 24, herein the macromolecule is factor IX. 26. A method according to claim 24, wherein the macromolecule is gammaglobulin. 27. A method according to claim 24, wherein the macromolecule is albumin. 28. A method according to claim 24, wherein the macromolecule is antithrombin III. 29. A method according to claim 24, wherein the macromolecule is a deletion derivative of recombinant factor VIII. 30. A filtration method according to claim 21, wherein the total salt content of the solution is within the range of from about 0.2 M to 1.5 M. 31. A method for obtaining parvo virus, comprising filtering a solution containing the virus, at least one macromolecule, and a salt, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation of the solution with the salt and the macromolecule is in solution during the filtering step. 32. A method for obtaining polio virus for use in a vaccine, comprising filtering a solution containing the virus, at least one macromolecule, and a salt, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation of the solution with the salt and the macromolecule is in solution during the filtering step. 33. 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 from about 0.2 M to 2 M and the virus-filtering step employs dead-end filtration. 34. 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 from about 0.6 M to 2 M. 35. A filtration method for 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, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M to 2 M. 36. A method according to claim 35, wherein non-lipid enveloped virus is removed from the solution. 37. A method according to claim 36, wherein non-lipid enveloped virus is selected form the consisting of hepatitis virus A, polio virus and parvo virus. 38. A method according to claim 35, wherein a lipid enveloped virus is removed from the solution. 39. A method according to claim 38, 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). 40. A method according to claim 35, wherein a virus smaller than about 350 nm is removed from the solution. 41. A method according to claim 40, wherein the virus removed from the solution is smaller than 200 nm. 42. A method according to claim 41, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 43. A filtration method for 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, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation with the salt, 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. 44. A method according to claim 43, wherein non-lipid enveloped virus is removed from the solution. 45. A method according to claim 44, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 46. A method according to claim 43, wherein a lipid-enveloped virus is removed from the solution. 47. A method according to claim 46, 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). 48. A method according to claim 43, wherein a virus smaller than about 350 nm is removed from the solution. 49. A method according to claim 48, wherein the virus removed from the solution is smaller than 200 nm. 50. A method according to claim 49, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm. 51. A filtration method for 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, comprising virus-filtering the solution containing at least one macromolecule, wherein the total salt content of the solution is within the range of from about 0.2 M up to saturation with the salt, and wherein the macromolecule is in solution during the virus filtering. 52. A method according to claim 51, wherein non-lipid enveloped virus is removed from the solution. 53. A method according to claim 52, wherein the non-lipid enveloped virus is selected from the group consisting of hepatitis virus A, polio virus and parvo virus. 54. A method according to claim 51, wherein a lipid-enveloped virus is removed from the solution. 55. A method according to claim 54, 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). 56. A method according to claim 51, wherein a virus smaller than about 350 nm is removed from the solution. 57. A method according to claim 56, wherein the virus removed from the solution is smaller than 200 nm. 58. A method according to claim 57, wherein the virus removed from the solution is smaller than 150 nm and larger than about 20 nm.

Details for Patent 6,486,306

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