Adenovirus formulations
AssigneeMerck & Co., Inc.
InventorsRobert K. Evans, David B. Volkin
Life of this patent
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Abstract
The invention relates to viral formulations and related pharmaceutical products for use in gene therapy and/or vaccine applications. Especially preferred viral formulations disclosed herein are liquid adenovirus formulations, which show improved stability when stored in about the 2-8° C. range while also being compatible with parenteral administration. These formulations comprise a buffer, a sugar, a salt, a divalent cation, a non-ionic detergent, as well as a free radical scavenger and/or a chelating agent to inhibit free radical oxidation.
Claims37
A virus formulation comprising:
- a) a purified virus;
- b) a buffer;
- c) a sugar;
- d) a salt;
- e) a divalent cation;
- f) a non-ionic detergent;
- and,
- g) an EDTA/ethanol combination.
An adenovirus formulation comprising a purified adenovirus and an EDTA/ethanol combination.
An adenovirus formulation with an adenovirus concentration in the range from about 1×107 vp/mL to about 1×1013 vp/mL and a total osmolarity in a range from about 200 mOs/L to about 800 mOs/L which comprises from about 5.0 mM to about 10 mM Tris at a pH from about 7.0 to about 9.0, sucrose at about 5% weight/volume, NaCl at about 75 mM, MgCl2 from about 1 mM to 2 mM, Polysorbate-80 from about 0.005% to about 0.1% weight/volume, EDTA at about 100 μM, ethanol at about 0.5% weight/volume, and histidine from about 5 mM to about 10 mM.
An adenovirus formulation comprising a recombinant adenovirus and an EDTA/ethanol combination.
Dependencies are inferred from the claim text.