Composition for viral preservation

Abstract

This invention relates to a composition for the preservation of a virus, the composition including a virus and a lipid.

1 . A composition for the preservation of a virus, the composition including a virus and a lipid.  
     
     
         2 . A composition according to  claim 1 , wherein the lipid is a cationic lipid, an anionic lipid, a zwitterionic lipid, a non-ionic lipid or any combination of these lipids.  
     
     
         3 . A composition according to  claim 1 , wherein the lipid is a cationic lipid.  
     
     
         4 . A composition according to  claim 3 , wherein the cationic lipid has a hydrophilic moiety including one or more amino residues.  
     
     
         5 . A composition according to  claim 4 , wherein the one or more amino residues is derived from an amino acid.  
     
     
         6 . A composition according to  claim 5 , wherein the one or more amino acids is lysine, arginine or histidine.  
     
     
         7 . A composition according to  claim 3 , wherein the cationic lipid is a poly-cationic lipid.  
     
     
         8 . A composition according to  claim 7 , wherein the poly-cationic lipid has a hydrophilic moiety including three lysine amino acids.  
     
     
         9 . A composition according to  claim 1 , wherein the lipid has a hydrophobic moiety including one or more hydrophobic groups.  
     
     
         10 . A composition according to  claim 9 , wherein the one or more hydrophobic groups includes an acyl, alkyl or alkoxy group.  
     
     
         11 . A composition according to  claim 10 , wherein the acyl group has a carbon chain length of 3 to 24 carbon atoms.  
     
     
         12 . A composition according to  claim 11 , wherein the acyl group is a laurate group.  
     
     
         13 . A composition according to  claim 9 , wherein the lipid has a hydrophobic moiety including three hydrophobic groups.  
     
     
         14 . A composition according to  claim 9 , wherein the lipid further includes a spacer group between the hydrophilic moiety and the hydrophobic moiety.  
     
     
         15 . A composition according to  claim 14 , wherein the spacer group has a chain length equivalent to 1 to 30 carbon-carbon single covalent bonds.  
     
     
         16 . A composition according to  claim 1 , wherein the lipid is a tris-conjugated cationic lipid.  
     
     
         17 . A composition according to  claim 16 , wherein the tris-conjugated cationic lipid has the following chemical formula:  
       
         
           
           
               
               
           
         
       
       or a salt thereof, wherein: 
 X is a positively charged hydrophilic moiety;  
 Y is spacer having a chain length equivalent to 1 to 30 carbon-carbon single covalent bonds or is absent; and  
 R 1 , R 2 , and R 3  are the same or different and are acyl groups derived from a fatty acid.  
 
     
     
         18 . A composition according to  claim 17 , wherein the tris-conjugated lipid has the following chemical formula:  
       
         
           
           
               
               
           
         
       
     
     
         19 . A composition according  claim 1 , wherein the concentration of lipid is in the range from 0.1 μM to 1 mM.  
     
     
         20 . A composition according to  claim 1 , wherein the concentration of lipid is in the range from 1 μM to 500 μM.  
     
     
         21 . A composition according to  claim 1 , wherein the concentration of lipid is in the range from 5 μM to 100 μM.  
     
     
         22 . A composition according to  claim 18 , wherein the concentration of lipid is 5 μM to 100 μM.  
     
     
         23 . A composition according to  claim 1 , wherein the virus is a virus derived from one or more of the group consisting of Adenoviridae, Herpesviridae, Poxviridae, Papovaviridae, Orthohepadnavirus, Parvoviridae, Birnaviridae, Reoviridae, Flaviviridae, Picornaviridae, Togaviridae, Filoviridae, Paramyxoviridae, Rhabdoviridae, Arenaviridae, Bunyaviridae, Orthomyxoviridae, and Retroviridae.  
     
     
         24 . A composition according to  claim 23 , wherein the virus is derived from the Adenoviridae family of viruses.  
     
     
         25 . A composition according to  claim 24 , wherein the virus is an ovine atadenovirus.  
     
     
         26 . A composition according to  claim 25 , wherein the virus is OAdV623 or a derivative of OAdV623.  
     
     
         27 . A composition according to  claim 1 , wherein the concentration of virus in the composition is in the range from 1×10 6  to 1×10 14  virus particles/ml.  
     
     
         28 . A composition according to  claim 1 , wherein the concentration of virus in the composition is in the range from 1×10 8  to 5×10 12  virus particles/ml.  
     
     
         29 . A composition according to  claim 1 , wherein the pH of the composition is in the range from 4 to 10.  
     
     
         30 . A composition according to  claim 1 , wherein the pH of the composition is in the range from 6 to 8.5.  
     
     
         31 . A composition according to  claim 1 , wherein the virus is storage stable.  
     
     
         32 . A composition according to  claim 31 , wherein the virus is storage stable when the composition is stored in liquid form.  
     
     
         33 . A composition according to  claim 32 , wherein the composition is stored at 0° C. to 30° C.  
     
     
         34 . A composition according to  claim 32 , wherein the composition is stored at 2° C. to 25° C.  
     
     
         35 . A composition according to  claim 32 , wherein he composition is stored at 2° C. to 8° C.  
     
     
         36 . A composition according to  claim 31 , wherein the composition is stored in the lyophilised, spray-dried or freeze-dried form.  
     
     
         37 . A composition according to  claim 36 , wherein the composition is stored at −20° C. to 30° C.  
     
     
         38 . A composition according to  claim 31 , wherein the composition is stored for 12 months or greater.  
     
     
         39 . A composition according to  claim 31 , wherein the composition is stored for 3 months or greater.  
     
     
         40 . A composition according to  claim 31 , wherein the composition is stored for 1 week or greater.  
     
     
         41 . A composition according to  claim 31 , wherein the composition is stored for 1 day or greater.  
     
     
         42 . A composition according to  claim 1 , wherein the virus is stable when the composition is subjected to one or more of agitation, shearing forces or mechanical action.  
     
     
         43 . A method of producing a composition for the preservation of a virus, the method including the step of preparing a liquid composition including a virus and a lipid.  
     
     
         44 . A method according to  claim 43 , wherein the lipid is a cationic lipid.  
     
     
         45 . A method according to  claim 44 , wherein the cationic lipid is a poly-cationic lipid.  
     
     
         46 . A method according to  claim 44 , wherein the lipid is a tris-conjugated cationic lipid.  
     
     
         47 . A method according to  claim 46 , wherein the tris-conjugated cationic lipid has the following chemical formula:  
       
         
           
           
               
               
           
         
       
       or a salt thereof, wherein: 
 X is a positively charged hydrophilic moiety;  
 Y is spacer having a chain length equivalent to 1 to 30 carbon-carbon single covalent bonds or is absent; and  
 R 1 , R 2 , and R 3  are the same or different and are acyl groups derived from a fatty acid.  
 
     
     
         48 . A method according to  claim 47 , wherein the tris-conjugated lipid has the following chemical formula:  
       
         
           
           
               
               
           
         
       
     
     
         49 . A method according to  claim 43 , wherein the virus is a virus derived from one or more of the group consisting of Adenoviridae, Atadenoviridae, Herpesviridae, Poxviridae, Parvoviridae, Papoviridae, Orthohepadnavirus, Parvoviridae, Birnaviridae, Reoviridae, Flaviviridae, Picornaviridae, Togaviridae, Filoviridae, Paramyxoviridae, Rhabdoviridae, Arenaviridae, Bunyaviridae, Orthomyxoviridae, and Retroviridae.  
     
     
         50 . A method according to  claim 49 , wherein the virus is derived from the Adenoviridae family of viruses.  
     
     
         51 . A method according to  claim 43 , wherein the virus is purified by a method including chromatography or centrifugation.  
     
     
         52 . A method according to  claim 43 , wherein the composition is formed by combining a solution including the virus with a solution including the lipid.  
     
     
         53 . A method according to  claim 43 , wherein the virus is storage stable.  
     
     
         54 . A method according to  claim 53 , wherein the virus is storage stable when the composition is stored in a liquid form.  
     
     
         55 . A method according to  claim 53 , wherein the virus is storage stable when the composition is stored in a lyophilised, freeze-dried or spray dried form.  
     
     
         56 . A method according to  claim 43 , wherein the virus is stable when the composition is subjected to one or more of agitation, shearing forces or mechanical action.  
     
     
         57 . A composition for the preservation of a virus, the composition including a virus and a lipid, wherein the virus is storage stable.  
     
     
         58 . A composition for the preservation of a virus, the composition including a virus and a lipid, wherein the virus is stable when the composition is subjected to one or more of agitation, shearing forces or mechanical action.