QUALITY CONTROL METHODS FOR OIL-IN-WATER EMULSIONS CONTAINING SQUALENE

摘要

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.

主权项

1. 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.