Description of Gardasil
Gardasil is the first approved human papillomavirus (HPV) prophylactic vaccine, which can protect against 4 types of HPV (6, 11, 16, and 18). The active ingredient in Gardasil is purified virus-like particles (VLPs) of the major capsid (L1) protein of 4 types of HPV. The adjuvant in Gardasil is based on aluminum. Gardasil was developed by Merck Sharp & Dohme (Merck) and available in 2006.
Synonyms
Recombinant Adsorbed Quadrivalent HPV VLP Vaccine (Yeast Origin), V-501, Gardasil, Silgard, 佳达修, ガーダシル
Formulation of Gardasil
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Active ingredients in Gardasil
HPV 6 L1 protein, HPV 11 L1 protein, HPV 16 L1 protein, HPV 18 L1 protein expressed in yeast Saccharomyces cerevisiae
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Adjuvant in Gardasil
Aluminum Hydroxyphosphate Sulfate
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Other ingredients in Gardasil
Sodium chloride, L-histidine, plysorbate 80, sodium borate, and water for injection.
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Expression system of HPV L1 Protein
Yeast (Saccharomyces cerevisiae)
Manufacturing Process of
Drug Substance Manufacturing
- Yeast fermentation to produce self-assembled VLPs
- Yeast cell disruption to release HPV L1 VLPs
- VLP purification
Drug Product Manufacturing
- Combining each type of VLP with aluminum-based adjuvant
- Formulation preparation and sterilizing filtration
- Aseptic fill-finish
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