Recombinant Subunit Vaccine

Modality

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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Recombinant Subunit Vaccine

Modality