Description of Engerix-B
Engerix-B is another licensed recombinant Hepatitis B Virus (HBV) vaccine consisting of Hepatitis B surface antigen (HBsAg) and aluminum-based adjuvant. Engerix-B was developed by GlaxoSmithKline (GSK) and was licensed in 1989.
Synonyms
Engerix-B, 安在时, HBsAg (Yeast), HBsAg (Saccharomyces cerevisiae)
Formulation of Engerix-B
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Active ingredients in Engerix-B
HBsAg of adw subtype HBV, expressed in yeast Saccharomyces cerevisiae
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Inactive ingredients in Engerix-B
Aluminum-based adjuvant, sodium chloride, disodium phosphate dihydrate, and sodium dihydrogen phosphate dihydrate
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Expression system of HBsAg VLP in Engerix-B
Yeast (Saccharomyces cerevisiae)
Manufacturing Process of Engerix-B
Drug Substance Manufacturing
- Yeast fermentation to produce self-assembled VLPs
- Yeast cell lysis to release HBsAg VLPs
- HBsAg VLP purification
Drug Product Manufacturing
- Combining HBsAg VLP with aluminum-based adjuvant
- Formulation preparation and aseptic fill-finish
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