Adenovirus formulations

1. A virus formulation comprising:

a) a purified virus;

b) a buffer;

c) a sugar;

d) a salt;

e) a divalent cation;

f) a non-ionic detergent; and,

g) an EDTA/ethanol combination.

2. A virus formulation of claim 1 with a virus concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL and a total osmolarity in a range from about 200 mOs/L to about 800 mOs/L.

3. A virus formulation of claim 1 with a virus concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL, wherein the buffer is a Tris buffer, at a pH from about 7.0 to about 9.0.

4. A virus formulation of claim 3 wherein the sugar is sucrose at a weight to volume percentage from about 2% to about 7.5% and the salt is sodium chloride from about 25 mM to about 250 mM, such that the total osmolarity of the formulation is a range from about 200 mOs/L to about 800 mOs/L.

5. A virus formulation of claim 4 wherein the divalent cation is selected from the group consisting of MgCl 2 and CaCl 2 in an amount from about 0.1 mM to about 5 mM.

6. A virus formulation of claim 5 wherein the non-ionic detergent is selected from the group consisting of Polysorbate-80 and Polysorbate-40 at a concentration range from about 0.001% to about 2%.

7. A virus formulation of claim 1 further comprising histidine.

8. A virus formulation of claim 1 with a concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL and a total osmolarity in a range from about 200 mOs/L to about 800 mOs/L wherein,

said buffer is about 1 mM Tris to about 10 mM Tris to provide a pH range from about pH 7.5 to about pH 8.5;

said sugar is sucrose present in a weight to volume range of about 2% to about 8%;

said salt is NaCl present in a range from about 25 mM to about 250 mM;

said divalent cation is MgCl 2 in a range from about 0.1 mM to about 5 mM;

said surfactant is Polysorbate-80 at a concentration from about 0.001% to about 0.25%; and

said EDTA/ethanol combination is a combination of EDTA from about 1 μM to about 500 μM and ethanol from about 0.1% to about 5.0%; and

further comprising histidine from 5 mM to 10 mM.

9. A virus formulation of claim 8 , wherein EDTA is at about 100 μM and ethanol is at about 0.5%.

10. A virus formulation of claim 2 comprising adenovirus and a formulation selected from the group consisting of formulation number A151b, A155, A159, A165, A167, A168, A169, A170, A171, A172 and A173.

11. An adenovirus formulation comprising a purified adenovirus and an EDTA/ethanol combination.

12. An adenovirus formulation of claim 11 further comprising a buffer, a sugar, a salt, a divalent cation, and a non-ionic detergent.

13. An adenovirus formulation of claim 12 with an adenovirus concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/ml and a total osmolarity in a range from about 200 mOs/L to about 800 mOs/L.

14. An adenovirus formulation of claim 13 , wherein the buffer is a Tris buffer, at a pH from about 7.0 to about 9.0.

15. An adenovirus formulation of claim 14 wherein the sugar is sucrose at a weight to volume percentage from about 2% to about 7.5% and the salt is sodium chloride from about 25 mM to about 250 mM.

16. An adenovirus formulation of claim 15 wherein the divalent cation is selected from the group consisting of MgCl 2 and CaCl 2 in an amount from about 0.1 mM to about 5 mM.

17. An adenovirus formulation of claim 16 wherein the non-ionic detergent is selected from the group consisting of Polysorbate-80 and Polysorbate-40 at a concentration range from about 0.001% to about 2%.

18. An adenovirus formulation of claim 11 , comprising:

about 1 mM Tris to about 10 mM Tris to provide a pH range from about pH 7.5 to about pH 8.5;

sucrose in a weight to volume range of about 2% to about 8%;

NaCl in a range from about 25 mM to about 250 mM;

MgCl 2 in a range from about 0.1 mM to about 5 mM;

Polysorbate-80 at a concentration from about 0.001% to about 0.25%;

EDTA from about 1 μM to about 500 μM; and

ethanol from about 0.1% to about 5.0%.

19. An adenovirus formulation of claim 18 , wherein EDTA is present from about 50 μM to about 250 μM, ethanol is present from about 0.25% to about 2.0% and further comprising histidine from 5 mM to 10 mM.

20. An adenovirus formulation of claim 12 further comprising histidine.

21. An adenovirus formulation of claim 12 wherein the sugar is sucrose at a weight to volume percentage from about 2% to about 7.5% and the salt is sodium chloride from about 25 mM to about 250 mM, such that the total osmolarity of the formulation is a range from about 200 mOs/L to about 800 mOs/L.

22. An adenovirus formulation of claim 21 wherein the divalent cation is selected from the group consisting of MgCl 2 and CaCl 2 in an amount from about 0.1 mM to about 5 mM.

23. An adenovirus formulation of claim 22 wherein the non-ionic detergent is selected from the group consisting of Polysorbate-80 and Polysorbate-40 at a concentration range from about 0.001% to about 2%.

24. An adenovirus formulation of claim 12 comprising adenovirus and a formulation selected from the group consisting of formulation number A151b, A155, A159, A165, A167, A168, A169, A170, A171, A172 and A173.

25. An adenovirus formulation of claim 20 wherein the sugar is sucrose at a weight to volume percentage from about 2% to about 7.5% and the salt is sodium chloride from about 25 mM to about 250 mM, such that the total osmolarity of the formulation is a range from about 200 mOs/L to about 800 mOs/L.

26. An adenovirus formulation of claim 25 wherein the divalent cation is selected from the group consisting of MgCl 2 and CaCl 2 in an amount from about 0.1 mM to about 5 mM.

27. An adenovirus formulation of claim 26 wherein the non-ionic detergent is selected from the group consisting of Polysorbate-80 and Polysorbate-40 at a concentration range from about 0.001% to about 2%.

28. An adenovirus formulation of claim 27 with an adenovirus concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL, wherein the buffer is a Tris buffer, at a pH from about 7.0 to about 9.0.

29. An adenovirus formulation of claim 12 , wherein

said purified adenovirus is present in a concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL;

the total osmolarity in a range from about 200 mOs/L to about 800 mOs/L;

said buffer is about 1 mM Tris to about 10 mM Tris to provide a pH range from about pH 7.5 to about pH 8.5;

said sugar is sucrose present in a weight to volume range of about 2% to about 8%;

said salt is NaCI is present in a range from about 25 mM to about 250 mM;

said divalent cation is MgCl 2 in a range from about 0.1 mM to about 5 mM;

said surfactant is Polysorbate-80 at a concentration from about 0.001% to about 0.25%; and

said EDTA/ethanol combination is a combination of EDTA from about 1 μM to about 500 μM, ethanol from about 0.1% to about 5.0%; and,

said formulation further comprises histidine.

30. An adenovirus formulation of claim 29 , wherein EDTA is at about 100 μM, ethanol is at about 0.5% and histidine is present from 5 mM to 10 mM.

31. An adenovirus formulation with an adenovirus concentration in the range from about 1×10 7 vp/mL to about 1×10 13 vp/mL and a total osmolarity in a range from about 200 mOs/L to about 800 mOs/L which comprises from about 5.0 mM to about 10 mM Tris at a pH from about 7.0 to about 9.0, sucrose at about 5% weight/volume, NaCl at about 75 mM, MgCl 2 from about 1 mM to 2 mM, Polysorbate-80 from about 0.005% to about 0.1% weight/volume, EDTA at about 100 μM, ethanol at about 0.5% weight/volume, and histidine from about 5 mM to about 10 mM.

32. An adenovirus formulation of claim 31 wherein the Tris buffer is present at about 10 mM, sucrose at about 5% weight/volume, NaCl at about 75 mM, MgCl 2 at about 1 mM, Polysorbate-80 from about 0.02% weight/volume, EDTA at about 100 μM, ethanol at about 0.5% weight/volume, and histidine at about 10 mM.

33. An adenovirus formulation comprising a recombinant adenovirus and an EDTA/ethanol combination.

34. An adenovirus formulation of claim 33 further comprising a buffer, a sugar, a salt, a divalent cation, and a non-ionic detergent.

35. An adenovirus formulation of claim 34 wherein the sugar is sucrose at a weight to volume percentage from about 2% to about 7.5% and the salt is sodium chloride from about 25 mM to about 250 mM, such that the total osmolarity of the formulation is a range from about 200 mOs/L to about 800 mOs/L.

36. An adenovirus formulation of claim 35 wherein the divalent cation is selected from the group consisting of MgCl 2 and CaCl 2 in an amount from about 0.1 mM to about 5 mM and the non-ionic detergent is selected from the group consisting of Polysorbate-80 and Polysorbate-40 at a concentration range from about 0.001% to about 2%.

37. An adenovirus formulation of claim 34 , comprising:

about 1 mM Tris to about 10 mM Tris to provide a pH range from about pH 7.5 to about pH 8.5;

sucrose in a weight to volume range of about 2% to about 8%;

NaCl in a range from about 25 mM to about 250 mM;

MgCl 2 in a range from about 0.1 mM to about 5 mM;

Polysorbate-80 at a concentration from about 0.001% to about 0.25%;

EDTA from about 1 μM to about 500 μM; and

ethanol from about 0.1% to about 5.0%.