Viral vector stabilization

Abstract

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 - 10 . (canceled) 
     
     
         11 . A method of preserving the infectivity of an infective vector, comprising: mixing an infective agent with a surfactant with an amount effective to preserve the infectivity of the agent, removing substantially all water from the mixture, and storing the mixture. 
     
     
         12 . The method of  claim 11 , where the infective vector comprises infective virus. 
     
     
         13 . The method of  claim 12 , where the surfactant comprises NODA. 
     
     
         14 . A 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, and wherein the surfactant has Structure I: 
       
         
           
           
               
               
           
         
       
     
     
         15 . The composition of  claim 14 , 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. 
     
     
         16 . The composition of  claim 14 , 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. 
     
     
         17 . The composition of  claim 14 , 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. 
     
     
         18 . The composition of  claim 14 , 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. 
     
     
         19 . The composition of  claim 18 , 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. 
     
     
         20 . The composition of  claim 14 , 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. 
     
     
         21 .- 32 . (canceled) 
     
     
         33 . The composition of  claim 14 , wherein the recombinant adenovirus is replication-deficient. 
     
     
         34 . The composition of  claim 14 , wherein the surfactant is in an amount effective to preserve the infectivity of the recombinant adenovirus at a temperature of 2° C. 
     
     
         35 .- 36 . (canceled) 
     
     
         37 . The composition of  claim 14 , wherein the recombinant adenovirus functions as a therapeutic vaccine. 
     
     
         38 . The composition of  claim 14 , wherein the recombinant adenovirus functions as a gene therapy vector. 
     
     
         39 . The composition of  claim 38 , wherein the recombinant adenovirus is replication-deficient and cannot replicate in normal human cells. 
     
     
         40 . The composition of  claim 43 , wherein the composition comprises nadofaragene firadenovec. 
     
     
         41 . The composition of  claim 14 , wherein the infective recombinant adenovirus comprises a transgene. 
     
     
         42 . The composition of  claim 41 , wherein the transgene encodes interferon. 
     
     
         43 . The composition of  claim 42 , wherein the interferon is interferon alpha-2b.