Stabilized nucleic acid compositions and methods of preparation and use thereof
AssigneeSelective Genetics, Inc.
InventorsXian Chen, Chenglie Ma, Mark J. D'Andrea
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Abstract
Preparations of nucleic acid condensates and compositions containing such condensates are provided. The nucleic acid condensates are in the form of small particles that are stable when subjected to destabilizing conditions such as lyophilizing, freeze-thawing, and prolonged liquid storage. These compositions may be used to deliver nucleic acid to cells.
Claims82
A composition comprising a nucleic acid condensed with a polycation in a liquid medium, thereby forming a particle, and at least one excipient selected from the group consisting of a zwitterion, an amorphous cryoprotectant, a crystalline bulking agent, and mixtures thereof wherein the particle increases in size by less than one-fold during storage in the liquid medium for one week at about 2° C. to about 8° C.
A condensate, comprising a nucleic acid, a polycation, and at least one excipient selected from the group consisting of a zwitterion, an amorphous cryoprotectant, a crystalline bulking agent, and mixtures thereof.
A lyophile prepared by the process comprising the steps:
- (a) combining water, nucleic acid, polycation, and an excipient, thereby forming a plurality of particles;
- and
- (b) removing water from (a).
A composition comprising components:
- (a) a nucleic acid;
- (b) a polycation;
- (c) an excipient;
- and
- further comprising a ligand covalently attached to at least one of the components and wherein the composition comprises a particle that increases in size by less than one-fold during storage in a liquid medium for one week at about 2° C. to about 8° C.
A method of preparing a condensed nucleic acid comprising the steps of:
- a. admixing a nucleic acid and a polycation in a liquid medium to form an admixture;
- b. incubating the admixture under conditions in which the nucleic acid and the polycation condense to form a plurality of particles;
- c. lyophilizing the admixture to remove the liquid medium thereby producing a lyophile comprising particles;
- and
- d. reconstituting the lyophile with a predetermined volume of a reconstituting medium to form a reconstituted composition comprising a plurality of particles that increase in size less than one-fold during storage in the reconstituting liquid for one week at about 2° C. to about 8° C.
Dependencies are inferred from the claim text.