Manufacture of Vaccines That Contain Both Hepatitis B Virus Surface Antigen and Surfactant
OwnerMario Contorniinventor
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Abstract
When preparing HBsAg for use in a combination vaccine, it is 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.
Claims56
A process for preparing a combination vaccine, wherein the vaccine comprises:
- (i) a non-ionic surfactant, (ii) a hepatitis B virus (HBV) surface antigen, and (iii) an antigen from at least one non-HBV pathogen, and wherein the process comprises:
- (i) 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;
- and (ii) combining the purified HBsAg component with at least one further antigen from a non-HBV pathogen, to give the combination vaccine.
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 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 was prepared by a process in which recombinant HBsAg-expressing yeast cells were disrupted in the presence of the non-ionic surfactant.
An immunogenic composition comprising (i) a non-ionic surfactant, (ii) a hepatitis B virus (HBV) surface antigen, and (iii) an antigen from at least one non-HBV pathogen, wherein the HBV surface antigen was prepared by a process in which recombinant HBsAg-expressing yeast cells were disrupted in the presence of the non-ionic surfactant.
The process of claim J_, wherein the HBV surface antigen is non-glycosylated.
(canceled)
A kit for preparing a pentavalent composition, wherein:
- the pentavalent composition comprises HBsAg, D, T, Pw and a Hib-T conjugate antigens;
- the D and T antigens are adsorbed to an aluminium hydroxide adjuvant;
- the HBsAg and Hib-T are adsorbed to an aluminium phosphate adjuvant;
- the HBsAg, D, T and Pw components are in aqueous form in a first container;
- the Hib-T is in lyophilised form in combination with lactose in a second container;
- and the HBsAg was prepared by a process in which recombinant HBsAg-expressing yeast cells were disrupted in the presence of the non-ionic surfactant.
A kit for preparing a heptavalent composition, wherein:
- the heptavalent composition comprises HBsAg, D, T, Pw, a Hib-T conjugate, a MenA conjugate and a MenC conjugate;
- the HBsAg, D, T and Pw components are in aqueous form in a first container;
- the three conjugates are lyophilised form in a second container;
- the first container also includes both aluminium hydroxide and aluminium phosphate adjuvants, wherein the D and T antigens are adsorbed to aluminium hydroxide and HBsAg is adsorbed to aluminium phosphate;
- and the HBsAg was prepared by a process in which recombinant HBsAg-expressing yeast cells were disrupted in the presence of the non-ionic surfactant.
Dependencies are inferred from the claim text.