Viral vector stabilization
Combining viral vector with surfactant preserves vector infectivity, and surfactant provided an unexpected benefit by protecting viral vector from damage due to transient elevated temperature.
1. A lyophilized composition comprising an infective recombinant adenovirus mixed with a surfactant in an amount effective to preserve the infectivity of the recombinant adenovirus, wherein the composition contains substantially no water, wherein the recombinant adenovirus comprises a transgene, and wherein the surfactant has Structure I:
2. The composition of claim 1 , wherein the recombinant adenovirus is replication-deficient.
3. The composition of claim 1 , wherein the surfactant is in an amount effective to preserve the infectivity of the recombinant adenovirus at a temperature of at least about 2° C.
4. The composition of claim 3 , wherein the surfactant is in an amount effective to preserve the infectivity of the recombinant adenovirus during transient storage at a temperature of at least about 2° C.
5. The composition of claim 1 , wherein the recombinant adenovirus functions as a therapeutic vaccine.
6. The composition of claim 1 , wherein the recombinant adenovirus functions as a gene therapy vector.
7. The composition of claim 1 , wherein the composition comprises a therapeutically-effective amount of the recombinant adenovirus.
8. A lyophilized composition comprising an infective recombinant adenovirus and a surfactant, the surfactant in an amount effective to preserve the infectivity of the recombinant adenovirus agent, whereby (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 100% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions and for the same time, wherein the composition contains substantially no water, and wherein the surfactant has Structure I:
9. The composition of claim 8 , wherein (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 117% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions and for the same time.
10. The composition of claim 9 , wherein (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 129% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions and for the same time.
11. The composition of claim 10 , wherein (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 142% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions and for the same time.
12. The composition of claim 8 , whereby (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 100% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions for at least three months.
13. The composition of claim 12 , whereby (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 100% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions for twelve months.
14. The composition of claim 8 , whereby (a) the infectivity of the recombinant adenovirus combined with the surfactant is at least 100% of (b) the infectivity of the recombinant adenovirus without the surfactant when stored under the same conditions and for the same time, wherein the conditions comprise at least one freeze-thaw cycle.
15. The composition of claim 8 , wherein the recombinant adenovirus is replication-deficient.
16. The composition of claim 8 , wherein the surfactant is in an amount effective to preserve the infectivity of the recombinant adenovirus at a temperature of 2° C.
17. The composition of claim 8 , wherein the recombinant adenovirus functions as a therapeutic vaccine.
18. The composition of claim 8 , wherein the recombinant adenovirus functions as a gene therapy vector.
19. The composition of claim 18 , wherein the recombinant adenovirus is a replication-deficient adenovirus and cannot replicate in normal human cells.
20. The composition of claim 19 , wherein the replication-deficient adenovirus comprises nadofaragene firadenovec.