In a recent milestone development under the Defense Advanced Research Project Agency (DARPA) “Blue Angel” program, researchers at Medicago Inc. produced more than 10 million doses of an H1N1 influenza vaccine candidate based on virus-like particles (VLP) in one month.

The Blue Angel program seeks to improve the nation’s ability to rapidly react to any natural or intentional pandemic disease. Program funding to Medicago was in support of developing new ways of producing large amounts of high-quality, vaccine-grade protein in less than three months in response to an outbreak.

This recent month-long “rapid fire” test displayed the potential for VLP vaccines to fill capability gaps of egg-based protein vaccine manufacturing during a crisis. The production lots adhered to Phase 1 current good manufacturing practices and were tested by a third party laboratory to confirm both the immunogenicity of the vaccine candidate and the number of doses produced.

“The results we’ve achieved here with plant-based production of vaccines represent both significant increase in scale and decrease in time-to-production over previous production capabilities in the same time period. The plant-made community is now better positioned to continue development and target FDA approval of candidate vaccines,” stated Dr. Alan Magill, DAPRA Program Manager. “Once the FDA has approved a plant-made vaccine candidate, the shorter production times of plant-made pharmaceuticals should allow DoD to be much better prepared to face whatever pandemic next emerges.”

To date, Medicago has received $19.8M in milestone payments from DARPA for this project, and expects to receive the fifth milestone payment of US $1M in the near future.