Description of Cecolin
Cecolin, a bivalent L1 antigen and aluminum adjuvant-based vaccine targeting HPV16 and HPV18, has been successfully expressed in Escherichia coli (E. coli) and has shown high immunogenicity in clinical studies. Cecolin, developed by Xiamen Innovax Biotech, was licensed by China NMPA (formerly CFDA) in China in December 2019, and has further received prequalification from WHO in October 2021.
Synonyms
Cecolin, Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli).
Formulation of Cecolin
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Active ingredients in Cecolin
HPV 16 L1 protein, HPV 18 L1 protein expressed in bacteria Escherichia coli
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Inactive ingredients in Cecolin
Aluminum adjuvant, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, polysorbate 80, and water for injection
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Expression system of HPV L1 Protein in Cecolin
Bacteria (Escherichia coli)
Manufacturing Process of Cecolin
Drug Substance Manufacturing
- Bacteria (E. coli) fermentation to produce VLPs
- E. coli disruption to release HPV L1 VLPs
- VLPs purification
Drug Product Manufacturing
- Combining each type of VLP with aluminum-based adjuvant
- Formulation preparation, sterilizing filtration and filling it in vials
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