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Click on icon to see table/diagram/imageHeberbiovac HB. Hepatitis B Recombinant vaccine (CIGS), contains a preparation of the surface antigen of the hepatitis B virus (HBV) obtained from cultures of a transformed yeast by the insertion in its genome of the gene coding for the antigen using recombinant DNA procedures.
The expression product of this gene is extracted and purified by a combination of physical, chemical and biochemical procedures. The purified surface antigen, obtained as an aggregate, forming particles of approximately 22 nm, is finally adsorbed in an aluminium hydroxide gel (0.5 mg. Al3+/dose of 20 μg) to which thiomersal is added as a preservative (0.05 mg/dose of 20 μg). The final product has the appearance of a white-gray material which sediments on the bottom of the container defining two phase: a clear supernatant, essentially protein-free composed of phosphate buffered saline (PBS) with the preservative substance dissolved, plus a precipitated aluminium-hydroxide gel with more than 98% of the antigen adsorbed. When shaken, an opaque gray suspension, takes place, lasting for some minutes, which is the form in which the product should be administered. Fermentation and purification processes have been optimized, scaled-up and standardized to maintain consistency and reproducibility from batch to batch.
