Back to results
US 8,551,527 B2Granted
Process for stabilizing an adjuvant containing vaccine composition
AssigneeSanofi Pasteur Limited
InventorsPierre Chouvenc, Alain Francon
Life of this patent
Estimating the term…
Abstract
The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.
Claims44
A process for producing a stabilized influenza vaccine composition comprising:
- a) diluting a liquid bulk antigen composition comprising an influenza antigen or an antigenic preparation from a seasonal, pre-pandemic or pandemic influenza virus strain with an aqueous solution comprising a carbohydrate, a sugar alcohol, or a mixture thereof in order to obtain a diluted vaccine composition solution wherein the concentration of the carbohydrate, sugar alcohol, or mixture thereof is from 2% (w/v) to the limit of solubility,
- b) prilling the diluted vaccine composition solution to form regular droplets of the vaccine having a diameter of approximately from about 200 μm to about 1500 μm,
- c) subjecting the regular droplets of the vaccine to freezing to form frozen regular spherical micropellets or particles of the vaccine, and
- d) drying the frozen regular spherical micropellets or particles of the vaccine to form dry regular spherical micropellets or particles of the vaccine having a diameter from about 200 μm to about 1500 μm.
1 more element
A process for stabilizing an adjuvant-containing vaccine composition comprising,
- a) diluting a liquid bulk antigen composition comprising an antigen or an antigenic preparation with an aqueous solution comprising a stabilizer and, optionally, one or more adjuvants to form a diluted vaccine composition,
- b) prilling the diluted vaccine composition to form regular droplets of the vaccine having a diameter of approximately from about 200 μm to about 1500 μm,
- c) subjecting the regular droplets of the vaccine to freezing to form frozen regular spherical micropellets or particles of the vaccine,
- d) drying the frozen regular spherical micropellets or particles of the vaccine to form dry regular spherical micropellets or particles of the vaccine having a diameter from about 200 μm to about 1500 μm,
- and if the liquid bulk composition of (a) did not comprise one or more adjuvants,
- e) diluting a separate liquid bulk solution or emulsion of one or more adjuvants with an aqueous solution comprising a stabilizer,
- f) prilling the diluted adjuvant solution or emulsion to form regular droplets of the adjuvant solution having a diameter of approximately from about 200 μm to about 1500 μm,
- g) subjecting the regular droplets to freezing to form frozen regular spherical micropellets or particles of the adjuvant solution,
- h) drying the frozen regular spherical micropellets or particles of the adjuvant solution to form dry regular spherical micropellets or particles of adjuvant composition having a diameter of from about 200 μm to about 1500 μm, and
- i) blending and filling the dry regular spherical micropellets or particles of adjuvant composition into a vial or other container together with the dry regular spherical micropellets or particles of the vaccine.
7 more elements
Dependencies are inferred from the claim text.