Method for producing sterile polynucleotide based medicaments

Details Method for producing sterile polynucleotide based medicaments Method for producing sterile polynucleotide based medicaments

C - Chemistry, Metallurgy

07

C

C07C 219/06 (2006.01) A61K 47/18 (2006.01) A61K 47/34 (2006.01) A61K 48/00 (2006.01) C07C 211/63 (2006.01) C07C 217/28 (2006.01) C07C 219/14 (2006.01) A61L 2/02 (2006.01)

Patent

CA 2508281

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.

La présente invention concerne un nouveau procédé permettant de produire des préparations contenant un polynucléotide, un copolymère bloc et un tensioactif cationique. Les préparations produites selon le mode de réalisation actuel peuvent être utilisées dans des médicaments à base de polynucléotides. Cette invention concerne un procédé de production adapté consistant, en outre, à filtrer à froid un mélange composé d'un polynucléotide, d'un copolymère bloc et d'un tensioactif cationique; puis à stériliser la préparation. Le procédé décrit dans cette invention permet également d'éliminer la nécessité de réaliser un cyclage thermique de la préparation, ce qui permet de réduire le temps et les dépenses nécessaires à la production de grandes quantités d'une préparation pendant sa fabrication à l'échelle commerciale. En outre, cette invention concerne des nouveaux lipides cationiques.

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