Speaking at the prestigious World Vaccine Congress recently held in Washington, D.C., the lead research scientist for AgriLabs® offered insights for moving a vaccine from research to commercial production using the company’s DNA vaccine platform as an example.
Dr. Tim Miller, chief scientific officer for AgriLabs, told attendees that working with USDA on the development plan early in the process has been 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,” Miller said. “Getting 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.”
Miller also advised participants of the World Vaccine Congress on the importance of making a master seed for vaccine testing and using it for all critical studies. These include validated potency tests and efficacy/safety trials such as work 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,” Miller said. “Without that work up front, commercialization may be impeded by costly and time-consuming repetition of key studies.”
About AgriLabs: AgriLabs® is a leader in biological innovation for animal health in the United States. Through proprietary DNA platform and adjuvant technologies, AgriLabs is delivering the next generation of vaccine solutions for farm animals. These technologies – combined with other innovative products and the leading distribution network in the United States – uniquely position AgriLabs to improve animal health, nutrition and productivity. For more information, visit agrilabs.com.
About Benchmark Biolabs: Benchmark Biolabs, a member of the AgriLabs® family of companies, is a contract research and development firm, specializing in the development of innovative animal health biological products and technologies from concept to commercialization. The team at Benchmark is responsible for dozens of issued patents, hundreds of USDA- and FDA- approved products and facilities, and many groundbreaking vaccine technology introductions across the globe.