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DARPA’s Blue Angel Makes 10 Million Strides In The Race To Contain A Hypothetical Pandemic
U.S. military forces are the front line of U.S. national security, but as a globally deployed force they are also on the front line of any new pathogen-based health threat that may emerge. As overall human activity pushes ever further into previously undeveloped territory, the likelihood of exposure to new pandemic diseases increases.
The 2009 Army Posture Statement, cites a World Health Organization estimate of between 20 and 50 percent of the world’s population being affected if a pandemic were to emerge. WHO forecasts “it may be six to nine months before a vaccine for a pandemic virus strain becomes available.” In a separate report on pandemic influenza, the WHO describes several challenges to producing sufficient volumes of vaccine using current, egg-based protein-production technology, including the likelihood that two doses per person could be required due to the absence of pre-existing immunity.
In short, the potential for a pandemic exists and current technological limitations on defensive measures put the health and readiness of U.S. military forces at risk. A technological solution to increase the speed and adaptability of vaccine production is urgently needed to match the broad biological threat.
DARPA’s Blue Angel program seeks to demonstrate a flexible and agile capability for the Department of Defense to rapidly react to and neutralize any natural or intentional pandemic disease. Building on a previous DARPA program, Accelerated Manufacture of Pharmaceuticals, Blue Angel targets new ways of producing large amounts of high-quality, vaccine-grade protein in less than three months in response to emerging and novel biological threats. One of the research avenues explores plant-made proteins for candidate vaccine production.
“Vaccinating susceptible populations during the initial stage of a pandemic is critical to containment,” said Dr. Alan Magill, DARPA program manager. “We’re looking at plant-based solutions to vaccine production as a more rapid and efficient alternative to the standard egg-based technologies, and the research is very promising.”
In a recent milestone development under Blue Angel, researchers at Medicago Inc. produced more than 10 million doses (as defined in an animal model) of an H1N1 influenza vaccine candidate based on virus-like particles (VLP) in one month. Production adhered to Phase 1 appropriate current good manufacturing practices. The work was part of a “rapid fire” test that ran from March 25, 2012, to April 24, 2012, at a facility in Durham, NC.
“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,” Magill said. “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.”
DARPA initiated the Blue Angel effort
in May 2009 to identify ongoing programs to assist in the Government-wide response to the H1N1 pandemic. The Blue Angel program is an accelerated and integrated effort to deliver effective interventions for pandemic influenza. Blue Angel brings together the following technologies to form a comprehensive approach in response to a pandemic influenza or manmade outbreak: Predicting Health and Disease (PHD), a program to predict and diagnose individuals exposed to influenza before they are symptomatic; Modular IMmune In vitro Constructs (MIMIC®), a program to identify safe and effective treatments in a test tube; and Accelerated Manufacture of Pharmaceuticals (AMP), a capability for rapidly mass producing low-cost, vaccine-grade recombinant protein that has the potential for scale up to tens of millions of doses per month. In response to the 2009 H1N1 swine flu pandemic, Blue Angel programs are currently in a “live-fire test” to demonstrate a flexible and agile capability for the Defense Department to rapidly react and neutralize any natural or intentional pandemic disease.
Predicting Health and Disease (PHD): PHD has developed a method for determining who will or will not become sick after exposure to a virus many days before symptoms appear, typically within 10 percent of the incubation period of a particular virus. This is accomplished using a highly accurate, mRNA-based blood test. By identifying key biomarkers for host response to respiratory viral infections, PHD can categorize viral-exposed individuals into specific categories—those who will be sick, those individuals who are contagious, and those who are well. Accuracy of this method is 85-90 percent within hours of viral exposure and achieves near 100-percent detection after a few days. High accuracy of detection enables prevention, prediction of disease propagation, and appropriate early treatment of infected individuals.
Accelerated Manufacture of Pharmaceuticals (AMP): This program seeks to identify new ways to produce large amounts of high-quality vaccine-grade protein in less than 3 months in response to emerging and novel biologic threats. In response to the 2009 H1N1 swine flu pandemic, as a “live-fire test,” the plant platform redirected its rapid scale-up process developed for avian influenza to the new H1N1 virus and produced a recombinant protein within 4 weeks.
Modular IMmune In vitro Constructs (MIMIC®): As animal studies are not always a good predictor of a vaccine’s safety and efficacy in a human, the MIMIC® system will work in parallel with the AMP program to test the subunit of vaccine produced under the AMP program to ensure it is safe and immunogenic.
2012-07-28 02:26:37
Source: http://nanopatentsandinnovations.blogspot.com/2012/07/darpas-blue-angel-makes-10-million.html
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