摘要 |
<p>A method comprising expressing the hepatitis B surface antigen (HBsAg) as a recombinant protein in Saccharomyces cerevisiae, processing the yeast cells to provide a crude antigen preparation, subjecting the crude antigen preparation to gel permeation chromatography, wherein the used elution buffer does not contain thiomersal, subjecting the antigen-containing eluant from step (c) to ion exchange chromatography, adding cysteine to the antigen-containing eluant pool obtained after previous step, subjecting the preparation from previous step to caesium chloride ultracentrifugation and combining the purified HBsAg with a pharmaceutically acceptable excipient to produce a stable, immunogenic hepatitis B vaccine, wherein no thiomersal id added to the resulting vaccine.</p> |