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US 2016/0235831 A1Published application
Process For Stabilizing An Adjuvant Containing Vaccine Composition
AssigneeSanofi Pasteur Limited
InventorsPierre Chouvenc, Alain Francon
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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.
Claims11
A stabilized dry C. difficile vaccine composition comprising micropellets or particles, wherein the micropellets or particles are prilled micropellets or particles with a diameter from about 200 μm to about 1500 μm, wherein the micropellets or particles are obtained by a process comprising,
- a) diluting a liquid bulk antigen composition comprising a protein antigen or an antigenic preparation from C. difficile 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 calibrated droplets of the vaccine having a diameter of approximately from about 200 μm to about 1500 μm,
- c) subjecting the droplets of the vaccine to freezing to form frozen spherical micropellets or particles of the vaccine, and
- d) drying the frozen spherical micropellets or particles of the vaccine to form dry spherical micropellets or particles of the vaccine having a diameter from about 200 μm to about 1500 μm.
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Dependencies are inferred from the claim text.