Abstract
Inactivated Foot-and-Mouth Disease (FMD) vaccine has proven to be effective in the control of the disease. However, its production has some disadvantages, including the costly biosafety facilities required for the production of huge amounts of growing live virus, the need of an exhaustive purification process to eliminate non-structural proteins of the virus in the final formulations in order to differentiate infected from vaccinated animals and variable local regulatory restrictions to produce and commercialize the vaccine. Thus, a novel vaccine against FMD that overcome these restrictions is desirable. Although many developments have been made in this regard, most of them failed in terms of efficacy or when considering their transferability to the industry. We have previously reported the use of transient gene expression in mammalian cells to produce FMD virus-like particles (VLPs) as a novel vaccine for FMD and demonstrated the immunogenicity of the recombinant structures in animal models. Here, we report the optimization of the production system by assaying different DNA:polyethylenimine concentrations, cell densities, and direct and indirect protocols of transfection. Also, we evaluated the reproducibility and scalability of the technology to produce high yields of recombinant VLPs in a cost-effective and scalable system compatible with industrial tech-transfer of an effective and safe vaccine.
Highlights
Foot-and-Mouth Disease (FMD) is a highly contagious and threatened disease of cloven-hoofed animals, endemic in many parts of the developing world [1]
We have previously demonstrated that virus-like particles (VLPs) based on A2001 Argentina strain, produced using transient gene expression (TGE) in suspension-growing cells, were able to elicit an immune response in a mouse model with a 100% protection after viral challenge, a response comparable to the one obtained using a similar amount of inactivated virus [20]
We compared the VLP yield obtained using wild type viral sequences and codon-optimized synthetic sequences for mammalian cells encoding for Foot and Mouth Disease Virus (FMDV) proteins
Summary
Foot-and-Mouth Disease (FMD) is a highly contagious and threatened disease of cloven-hoofed animals, endemic in many parts of the developing world [1]. It is one of the most important animal health concerns from an economic point of view and continues to pose a serious threat to farmers, livestock industries and governments. Vaccination programs in endemic countries or those FMD free with vaccination. The policy of applying vaccination to respond to incursions in FMD free countries, known as “vaccination to live,” gained acceptance as a result of public questioning after the slaughter of millions of animals due to large outbreaks in Europe in 2001 [2, 3]. Vaccination is useful in many possible scenarios: for prevention or control of an outbreak in FMD-free areas and for the control of the disease in endemic regions
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