Quality control methods for oil-in-water emulsions containing squalene
AssigneeNovartis AG
InventorNorbert Klein
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Abstract
Measurements of the squalene content in oil-in-water emulsions can be used as a way of checking for problems during production. In particular, it has been found that a drop in squalene content can indicate that filtration problems occurred. Testing the squalene content in the final lots is easier than investigating the characteristics of the filter, and so a squalene assay simplifies the quality control of oil-in-water emulsions.
Claims25
A method for manufacturing an oil-in-water emulsion adjuvant, comprising the steps of:
- (i) preparing a submicron oil-in-water emulsion using known amounts of an aqueous carrier, a surfactant and squalene;
- (ii) subjecting the emulsion to filter sterilization, to provide a sterilized emulsion;
- and (iii) measuring the squalene content of the sterilized emulsion.
A quality control test method for an oil-in-water emulsion adjuvant, wherein the adjuvant comprises squalene, and wherein the method comprises a step of comparing the actual squalene content of the adjuvant to a standard squalene content.
A quality control test method for a vaccine that includes an oil-in-water emulsion adjuvant including squalene, wherein the method comprises the steps of:
- (i) comparing the actual squalene content of the adjuvant to a standard squalene content;
- and, if the actual squalene content is acceptable, (ii) preparing the vaccine by combining the adjuvant with an antigen.
A method comprising a step of mixing (i) an influenza virus antigen and (ii) an oil-in-water emulsion adjuvant that includes squalene, wherein the method also includes a step in which squalene content is measured (a) in the adjuvant before the mixing step and/or (b) in the antigen-adjuvant mixture after the mixing step.
Dependencies are inferred from the claim text.