TEMPERATURE-RESPONSIVE VIRUS STORAGE SYSTEM
A temperature-responsive virus storage system that allows virus to be stored, such as a non-frozen liquid, and maintain infectivity is described.
1 . A composition comprising:
an infective virus and a final buffer made by combining one part (w/w) of a buffer formulation with nine parts (w/w) purified water,
wherein the composition comprises the infective virus suspended therein at a concentration of about 3×10 11 adenoviral particles per mL of buffer; and
wherein the buffer formulation comprises the following components, in an amount (w/w) of each component expressed as a percent of the weight of tromethamine used to make the buffer:
about 6000% glycerol;
about 1214% sucrose;
about 100% tromethamine;
about 100% sodium dihydrogen phosphate dihydrate;
about 560% hydroxypropyl beta-cyclodextrin;
about 29% magnesium chloride hexahydrate;
about 68% (3α,53,7α,12α)-N-[3[(4-O-D-galactopyranosyl-D-gluconoyl)amino]propyl]-3,7,12-trihydroxy-N-[3-[[(3α,53,7α,12α)-3,7,12-trihydroxy-24-oxocholan-24-yl]amino]propyl]-cholan-24-amide (NODA)
about 34% polysorbate 80;
about 2.8% sodium citrate dihydrate; and
about 0.71% citric acid monohydrate.
2 . The composition of claim 1 , wherein the infective virus is a Lentivirus , adenovirus or adeno-associated virus.
3 . The composition of claim 2 , wherein the infective virus is a replication-deficient adenovirus.
4 . A method of treating a subject suffering from bladder cancer, the method comprising administering to the subject the composition of claim 1 .
5 . The method of claim 4 , wherein the adenoviral particles are recombinant adenoviral particles encoding human interferon α-2b.
6 . The method of claim 4 , wherein the infective virus is a Lentivirus, adenovirus or adeno-associated virus.
7 . The method of claim 5 , wherein the infective virus is a replication-deficient adenovirus.
8 . The method of claim 4 , wherein is a high-grade non-muscle-invasive bladder cancer.
9 . The method of claim 4 , wherein the bladder cancer is carcinoma in situ (CIS) with or without high-grade papillary disease.
10 . The method of claim 4 , wherein the bladder cancer is Bacillus Calmette-Guérin (BCG)-resistant cancer.