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9-valent HPV vaccine, Gardasil 9

9-valent HPV vaccine, Gardasil 9 România

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9-valent HPV Vaccine, Gardasil 9

Description of Gardasil 9

Gardasil 9 is a recombinant human papillomavirus (HPV) vaccine against 9 types of HPV, i.e., types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The active ingredient in Gardasil 9 is purified virus-like particles (VLPs) of the major capsid (L1) protein of the 9 types of HPV. Gardasil 9 contains aluminum-based adjuvant. Gardasil 9 was developed by Merck Sharp & Dohme and was available in 2014.

Synonyms

V503, Gardasil 9, Silgard 9, 佳达修 9,シルガード 9.

Formulation of Gardasil 9

Active ingredients in Gardasil 9

HPV 6 L1 protein, HPV 11 L1 protein, HPV 16 L1 protein, HPV 18 L1 protein, HPV 31 L1 protein, HPV 33 L1 protein, HPV 45 L1 protein, HPV 52 L1 protein, HPV 58 L1 protein expressed in yeast Saccharomyces cerevisiae  

Inactive ingredients in Gardasil 9

Aluminum hydroxyphosphate sulfate (adjuvant), sodium chloride, L-histidine, plysorbate 80, sodium borate, and water for injection.

Expression system of HPV L1 Protein

Yeast (Saccharomyces cerevisiae)

Manufacturing Process of HPV L1 Protein
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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