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Recombinant Subunit Vaccine

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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 (Saccharomyces cerevisiae, Hansenula polymorpha, Pichia 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.

Approved Recombinant Subunit Vaccines

Category

Approved Products

Hepatitis B Virus (HBV) Vaccine

RECOMBIVAX HB (S. cerevisiae), PREHEVBRIO (CHO cell), ENGERIX-B (S. cerevisiae), HEPLISAV-B (H. polymorpha)

Hepatitis E Virus (HEV) Vaccine

Hecolin (E. coli)

Human Papillomavirus (HPV) Vaccine

4-valent Gardasil (S. cerevisiae), 9-valent Gardasil 9

HPV Vaccine (types 16 and 18)

Cervarix (Baculovirus), Cecolin (E. coli)

Influenza (Flu) Vaccine

Flublok (Baculovirus)

Meningococcal Group B (MenB) Vaccine

BEXSERO (E. coli), RUMENBA (E. coli)

Respiratory Syncytial Virus (RSV) Vaccine

ABRYSVO (CHO cell), AREXVY (CHO cell)

Malaria Vaccine

RTS,S/AS01, Mosquirix (S. cerevisiae)

Zoster Vaccine

SHINGRIX (CHO cell)

Recombinant Subunit Vaccines On Development (Partial)

Category

Typical Pipelines

Human Lyme Borreliosis Vaccine

LYMErix (GSK ), VLA15 (Pfizer)

Human Leishmania Vaccine

LEISH-F1, LIESH-F2, and LEISH-F3

Canine Leishmania Vaccine

Leish-Tec (Hertape), LetiFend (Laboratorios Salud Animal)

Feline Leukemia Virus Vaccine

Leucogen (Virbac), Nobivac LeuFel (Merck)

Equine Streptococcus equi Vaccine

Strangvac (Intervacc)
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Recombinant Subunit Vaccine
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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