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US 8,802,111 B2Granted
Manufacture of vaccines that contain both hepatitis B virus surface antigens and surfactant
AssigneeNovartis Vaccines and Diagnostics, Inc.
InventorMario Contorni
Life of this patent
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Abstract
When preparing HBsAg for use in a combination vaccine, it us known to add a non-ionic detergent after the HBsAg has been purified. Adding detergents after purification of HBsAg is not optimal, however, as it requires a separate processing step during manufacture. Thus the invention uses them during HBsAg purification.
Claims36
A process for preparing a combination vaccine, wherein the vaccine comprises:
- (i) a non-ionic surfactant, (ii) a hepatitis B virus (HBV) surface antigen (HBsAg), and (iii) an antigen from at least one non-HBV pathogen, and wherein the process comprises:
- (a) purifying the HBV surface antigen from recombinant yeast cells, wherein the purification includes a step in which the yeast cells are disrupted in the presence of the non-ionic surfactant, to give a purified HBsAg component wherein the process does not involve a step of adding the non-ionic surfactant as a separate component after HBsAg purification;
- (b) adsorbing the purified HBsAg component to aluminium phosphate;
- and (c) combining the adsorbed HBsAg component with at least one further antigen from a non-HBV pathogen, to give the combination vaccine.
1 more element
A process for preparing a combination vaccine, wherein the vaccine comprises:
- (i) a non-ionic surfactant, (ii) a hepatitis B virus (HBV) surface antigen (HBsAg) adsorbed onto an aluminium phosphate adjuvant, and (iii) an antigen from at least one non-HBV pathogen, and wherein the process comprises the step of combining a purified HBsAg with at least one further antigen from a non-HBV pathogen, to give the combination vaccine, wherein the HBsAg:
- (a) is prepared by a process in which recombinant HBsAg-expressing yeast cells are disrupted in the presence of the non-ionic surfactant, where the non-ionic surfactant is retained within the HBsAg particle, and wherein the process does not involve a step of adding the non-ionic surfactant as a separate component after HBsAg purification;
- and (b) is pre-adsorbed to the aluminium phosphate.
Dependencies are inferred from the claim text.