Description of Recombivax HB
Recombivax HB is an approved Hepatitis B Virus (HBV) vaccine, which is based on the adw subtype of Hepatitis B surface antigen (HBsAg). Recombivax HB constains aluminum-based adjuvant. Gardasil was developed by Merck Sharp & Dohme (Merck) and was licensed in 1986. Moreover, Recombivax HB is the first virus-like particles (VLPs) vaccine.
Synonyms
Hepatitis B Vaccine (Recombinant), Heptavax-II, Recombivax HB, Recombivax, Recombivax Hb
Formulation of Recombivax HB
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Active ingredients in Recombivax HB
Recombinant HBsAg derived from adw subtype HBV, expressed in yeast Saccharomyces cerevisiae
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Adjuvant in Recombivax HB
Amorphous aluminum hydroxyphosphate sulfate
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Expression system of HBsAg in Recombivax HB
Yeast (Saccharomyces cerevisiae)
Manufacturing Process of HBsAg
Drug Substance Manufacturing
- Yeast fermentation to produce self-assembled VLPs
- Yeast cell lysis to release HBsAg VLPs
- HBsAg VLP purification
Drug Product Manufacturing
- Formaldehyde treatment and removal
- Combining HBsAg VLP with aluminum-based adjuvant
- Formulation preparation and aseptic fill-finish
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