High concentration chitosan-nucleic acid polyplex compositions
AssigneeenGene, Inc.
InventorsEric Hsu, Carlos Fleet, Anthony Cheung, Jun Gao
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Abstract
The invention provides highly concentrated chitosan-nucleic acid polyplex compositions and dispersions, and methods for producing the compositions and dispersions. Methods of mixing the chitosan-nucleic acid polyplexes include an inline mixing of chitosan solution and nucleic acid solution, followed by further concentrating the dispersion of chitosan-nucleic acid polyplexes, optionally with an aggregation inhibitor. Further provides are methods for altering the diameter of chitosan-nucleic acid polyplexes.
Claims24
A concentrated dispersion of chitosan-nucleic acid polyplexes produced by a method of concentrating chitosan-nucleic acid polyplexes, said method comprising providing a non-concentrated dispersion of chitosan-nucleic acid polyplexes comprising chitosan molecules having an average molecular weight less than 100 kDa and an aggregation inhibitor, and concentrating said non-concentrated dispersion of chitosan-nucleic acid polyplexes using a means for concentrating said non-concentrated dispersion to form a concentrated dispersion of stable chitosan-nucleic acid polyplexes, wherein said polyplexes have an N:P ratio greater than or equal to 5:1, wherein said concentrated dispersion has a nucleic acid concentration greater than or equal to 0.5 mg/ml and less than or equal to about 1.5 mg/ml and is free of polyplex precipitate, and wherein said aggregation inhibitor in said concentrated dispersion is a sugar having a concentration of between about 3% and 20% by weight.
Dependencies are inferred from the claim text.