Temperature-responsive virus storage system

A method of preserving the infectivity of an infective virus, the method comprising the steps of:

• storing a composition comprising an infective virus in a frozen state at a temperature lower than or equal to −60° C. for at least one year to preserve the infectivity of the virus,
• wherein the virus is an infective replication-deficient adenovirus encoding interferon α-2b;
• further wherein the composition comprises the virus and a final buffer which is made from a combination of one part (w/w) of a buffer formulation with nine parts (w/w) purified water;
• further wherein, the virus is suspended in the composition at a concentration of about 3×1011 adenoviral particles per mL of buffer;
• and
• still further 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,5β,7α,12α)-N-[3-[(4-O-D-galactopyranosyl-D-gluconoyl)aminolpropyl]-3,7,12-trihydroxy-N[3-[[(3α,5β,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.