The present invention relates to a novel method for producing formulations
comprising a polynucleotide, block copolymer and cationic surfactant. The
formulations produced by the current method are suitable for use in
polynucleotide based medicaments. A suitable method of production
disclosed herein additionally comprises cold filtering a mixture of a
polynucleotide, block copolymer and cationic surfactant, thereby
sterilizing the formulation. The method of the present invention also
eliminates the need for thermal cycling of the formulation, thereby
reducing the time and expense required to produce large quantities of a
formulation during commercial manufacturing. The present invention also
relates to novel cationic lipids.