ABSTRACT
Engerix-B is a recombinant vaccine against the hepatitis B virus. It contains the major surface antigen of the hepatitis B virus. This protein is produced in S. cereυisiae using recombinant DNA technology. Purification involves several chromatographic steps, including ion exchange and gel permeation chromatography, as well as various filtration and ultracentrifugation procedures. The HBsAg molecules assemble spontaneously into characteristic spherical particles of 20-nm average diameter. The product is adsorbed on aluminium hydroxide. Engerix-B is presented as a suspension containing the HBsAg (active) as well as aluminium hydroxide, sodium chloride, dihydrate disodium phosphate, dihydrate dihydrogen sodium phosphate, and thimerosal as excipients. A formulation for pediatric and adolescent use is supplied without a preservative (thimerosal). Engerix-B is presented as a suspension for intramuscular administration in vials or prefilled syringes.
