Poxvirus containing formulations and process for preparing stable poxvirus containing compositions
AssigneeBavarian Nordic A/S
InventorsPaul Howley, Karl Heller, Ingmar Räthe
Life of this patent
Estimating the term…
Abstract
The present invention relates to a formulation, in particular an aqueous formulation comprising (i) a poxvirus of one of the genera orthopoxvirus, avipoxvirus, parapoxvirus, capripoxvirus and suipoxvirus, (ii) a disaccharide, (iii) a pharmaceutically acceptable polymer and optionally (iv) a buffer. The aqueous formulation is particularly suitable for freeze drying processes resulting in a stable, freeze-dried, poxvirus containing composition. The invention further concerns a method for preparing a freeze-dried, poxvirus containing composition and the thus obtained product.
Claims20
A formulation comprising:
- (a) a purified or partially purified poxvirus selected from the group consisting of Orthopoxviruses, Parapoxviruses, Avipoxviruses, Capripoxviruses, and Suipoxviruses;
- (b) a disaccharide;
- (c) a pharmaceutically acceptable polymer;
- and
- (d) a buffer excluding a phosphate buffer,
- wherein the formulation is substantially free of non-poxvirus associated proteins.
A method of preparing a freeze-dried, stable poxvirus-containing vaccine which comprises the following steps:
- (i) freezing a formulation comprising:
- (a) a purified or partially purified poxvirus selected from the group consisting of Orthopoxviruses, Parapoxviruses, Avipoxviruses, Capripoxviruses, and Suipoxviruses;
- (b) a disaccharide;
- (c) a pharmaceutically acceptable polymer;
- and
- (d) a buffer excluding a phosphate buffer, to obtain a frozen formulation, wherein the formulation is substantially free of non-poxvirus associated proteins;
- (ii) primarily drying the frozen formulation obtained according to step (i) under low pressure and at a product temperature allowing sublimation of the ice in the product matrix, wherein the product temperature is lower than the collapse temperature of the formulation, to obtain a freeze-dried product and
- (iii) secondarily drying the freeze-dried product obtained according to step (ii) at low pressure and at a product temperature in the range of 0 to 30° C. until the residual moisture of the freeze-dried product is lower than 5%.
Dependencies are inferred from the claim text.