Stable gene preparations
View Patent ↗The invention is directed to the retention of the stability of formulations useful for a gene therapy during the preparation and preservation. In the invention, at least one saccharide and/or at least one non-hydrophobic amino acid and/or at least one organic acid having two or more carboxyl groups except amino acids, or a collagen or a gelatin and at least one amino acid are added to a gene formulation.
1. A method for stabilizing a closed circular DNA molecule in a formulation, comprising:
adding citric acid or tartaric acid, or a salt thereof, to an aqueous solution of the closed circular DNA and atelocollagen, and
lyophilizing the solution.
2. The method of claim 1 , wherein the aqueous solution of the closed circular DNA further comprises a cationic lipid, a cationic polymer or a hydrophobic polymer.
3. The method of claim 2 , wherein the amount of citric acid or tartaric acid is not less than 1% w/v of the aqueous solution of the closed circular DNA.
4. The method of claim 1 , wherein the amount of citric acid or tartaric acid is not less than 1% w/v of the aqueous solution of the closed circular DNA.
5. A method for stabilizing a closed circular DNA molecule in a formulation, comprising:
adding atelocollagen to an aqueous solution of the closed circular DNA and citric acid or tartaric acid or both citric acid and tartaric acid, or a salt thereof, and
lyophilizing the solution.
6. The method of claim 5 , wherein the aqueous solution of the closed circular DNA further comprises a cationic lipid, a cationic polymer or a hydrophobic polymer.
7. The method of claim 6 , wherein the amount of citric acid or tartaric acid is not less than 1% w/v of the aqueous solution of the closed circular DNA.
8. The method of claim 5 , wherein the amount of citric acid or tartaric acid is not less than 1% w/v of the aqueous solution of the closed circular DNA.