Media Coverage

AgriLabs progresses toward commercial launch of DNA vaccine platform

May 04, 2017 - Animal Pharm

By Joseph Harvey
Animal Pharm
May 4, 2017

US firm AgriLabs is nearing commercialization of the first DNA vaccine platform for food animals in the US market.

The line of vaccines will feature the company's ENABL adjuvant technology. AgriLabs claims the vaccines offer low-dose, safe, DIVA-compliant and stable alternatives to the animal health industry.

A DNA vaccine contains a genetic sequence that triggers the production of proteins in the cells of the vaccinated animal and consequentially stimulates a protective immune response. AgriLabs' technology allows for enhanced manufacturing lead times, which enables the DNA platform to be suited to tackling emerging diseases such as avian influenza.

A spokesperson for the St Joseph, Missouri-based business told Animal Pharm: "Initial target species are poultry and swine, with cattle to follow. AgriLabs is seeking other commercial partners to license this DNA vaccine platform for companion animal usage and food animal outside the US."

Last year, AgriLabs made several significant acquisitions in a bid to become a fully integrated concept-to-commercialization business for food animal vaccines. The commercialization of the DNA vaccine platform is a result of this move.

Working with USDA

Speaking at the recent World Vaccine Congress in Washington, DC, the lead research scientist for AgriLabs said the firm had been working with the USDA on its product development plan early on in the regulatory process.  Dr Tim Miller, chief scientific officer for AgriLabs, said this early-stage relationship with the USDA was key in the commercialization efforts for the DNA vaccine platform.

"AgriLabs is excited about the potential of the DNA vaccine platform, which includes ENABL adjuvant technology, in the fight against important and emerging animal diseases," Dr Miller said. "Getting the USDA's feedback on our development plan at an early stage has been instrumental to our progress toward the first commercial approval of the platform."

Dr Miller also hailed the importance of making a master seed for vaccine testing and using it for all critical studies. These studies include validated potency tests and efficacy/safety trials, which are needed to generate a 'Finding of No Significant Environmental Impact', or FONSI. A FONSI is required for a recombinant DNA product.

"Early planning is required to ensure appropriate testing materials," he explained. "Without that work up front, commercialization may be impeded by costly and time-consuming repetition of key studies."

AgriLabs will continue to sell its ready-to-use ENABL adjuvants as standalone products. The benefit of the ENABL technology is that it does not use animal-origin material and it contains GRAS (Generally Recognized As Safe) ingredients. This means manufacturers can produce vaccines more safely.

Reprinted with permission of Animal Pharm News




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