Recombinant Subunit Vaccine
Recombinant subunit vaccines, also known as recombinant protein vaccines, are made up of viral or bacterial antigens, which consist of single and simple proteins or complex structure such as virus-like particle (VLP). Recombinant subunit vaccines are generated using recombinant DNA technology.
Various expression systems such as bacteria (Escherichia coli), yeasts (S. cerevisiae, P. pastoris), insect cells, mammalian cells, or even plants, can be applied to meet the challenges and bottlenecks of recombinant protein vaccine manufacturing.
The first subunit vaccine against hepatitis B virus (HBV), Heptavax, was authorized in 1986. Heptavax is self-assembled into VLP based on hepatitis B surface antigen (HBsAg) using yeast S. cerevisiae as an expression system. After that, HPV, a vaccine targeting human papillomavirus and using L1 structural protein, was introduced and entered the market in 2006 and 2007. This was a huge success and subsequently brought about approvals of several recombinant subunit vaccines against viruses or bacteria.
Recombinant subunit vaccines are used to protect against:
- Hepatitis B virus (HBV), like RECOMBIVAX HB (Saccharomyces cerevisiae), PREHEVBRIO (CHO cell), ENGERIX-B (Saccharomyces cerevisiae), HEPLISAV-B (Hansenula polymorpha)
- Hepatitis E Virus (HEV), like Hecolin (Escherichia coli)
- Human papillomavirus (HPV), like 4-valent Gardasil (Saccharomyces cerevisiae), 9-valent Gardasil 9
- HPV (types 16 and 18), like Cervarix (Baculovirus), Cecolin (E. coli)
- Influenza (Flu), like Flublok (Baculovirus)
- Meningococcal Group B (MenB) like BEXSERO (Escherichia coli), RUMENBA (Escherichia coli)
- Respiratory Syncytial Virus (RSV), like ABRYSVO (CHO cell), AREXVY (CHO cell)
- Zoster, like SHINGRIX (CHO cell)
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Recombinant Subunit Vaccine
- Microbial Strain Engineering and Screening
- Microbial Cell Banking (PCB/MCB/WCB)
- Upstream Process Development
- Downstream Process Development
- Formulation Development
- GMP Manufacturing
- Fill and Finish
- Analytical and Testing
- Regulatory Affairs
Reference:
Cid R, Bolívar J. Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies. Biomolecules. 2021 Jul 21;11(8):1072. doi: 10.3390/biom11081072.
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