The Defense Department has contributed core capabilities to a national center funded as a public-private partnership by the Department of Health and Human Services to enhance the U.S. response to infectious diseases and biological, chemical, radiological and nuclear threats.
The HHS Texas A&M Center for Innovation in Advanced Development and Manufacturing is a response in part to pandemics such as the 2009-2010 H1N1 flu – for which traditional biomanufacturing methods took 26 weeks to produce initial vaccine doses ñ and the future threat of biological attacks and other public health emergencies.
According to expert witnesses testifying here Oct. 11 before the House Armed Services Committees subcommittee on intelligence, emerging threats and capabilities, some kinds of advances in biomanufacturing processes and DNA technologies have lowered the bar for states, and even individuals, who seek to produce biological weapons.
One of the witnesses was Dr. Brett P. Giroir, principal investigator at the Texas A&M Center for Innovation, and interim vice president and chief executive officer of the Texas A&M Health Sciences Center.
Literally, what once took weeks during medical school to produce in a multimillion-dollar laboratory can be done [today] in an afternoon on a benchtop by someone with a relatively less degree of scientific training, he told the panel. So the barriers to entry have decreased.
Giroirs work at the Texas A&M Center for Innovation began in 2008 after nine years at the Defense Advanced Research Projects Agency.
During his first five years at DARPA, Giroir was a member of the Defense Sciences Research Council, for which he chaired or co-chaired intensive studies on chemical, biological, radiological and nuclear security and countermeasures, decontamination and warfighter performance under extreme conditions, he said in written testimony.
Then, as deputy director and later director of the DARPA Defense Sciences Office, he and a team of scientists, physicians and engineers developed a platform of research initiatives called Accelerating Critical Therapeutics, or ACT, he said.
ACT was designed to provide new, highly effective medical countermeasures and an unprecedented, flexible and rapid response to address the growing threat of genetically modified or chimeric organisms — single organisms with two or more sets of genetically distinct cells — for which no vaccines or countermeasures existed.
One aspect of the DARPA portfolio that was extremely challenging, even for DARPA, he said, was the ability to develop low-cost, highly flexible and adaptable biomanufacturing technologies that could provide tens of millions of doses of vaccines or medical countermeasures such as chemical-weapon antidotes within weeks of notification.
Such a capability didnt exist in the civilian or military experience, Giroir said, and profound technical and financial barriers kept the problem unsolved for several years.
In 2008, when my assignment at DARPA was completed, I joined the Texas A&M system [and] secured a $50 million investment from the state of Texas to demonstrate those flexible manufacturing capabilities originally envisioned at DARPA, Giroir told the panel.
Beginning in 2009, he added, Texas A&M designed, developed, constructed and is now operating a revolutionary first-in-class, 150,000-square-foot facility that has pioneered highly flexible, adaptable and even mobile manufacturing platforms at a capital cost of about 80 percent less than the current state of the art.
The facility is called the National Center for Therapeutics, or NCTM, and a key feature there is the use of modular and mobile stand-alone biopharmaceutical clean rooms, called modular clear rooms, or MCRs. The initial MCR concept was funded by DOD through DARPA and the Army Research Office, Giroir said.
NCTM is the core facility and main site for developing and manufacturing medical countermeasures and vaccines against chemical, biological, radiological and nuclear threats for the Texas A&M Center for Innovation, he added.
Another part of the Center for Innovations biomanufacturing infrastructure is the Caliber Biotherapeutics Facility, Giroir said. Caliber was developed and built through Texas A&M and G-CON Manufacturing, with funding from the DARPA Blue Angel Program.
According to a 2012 DARPA news release, the Blue Angel Program demonstrated a flexible and agile capability for DOD to rapidly react to and neutralize any natural or intentional pandemic disease.
Building on a previous DARPA program, Blue Angel targeted new ways to produce 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 explored plant-made proteins for producing a candidate vaccine.
In a milestone development under the program, researchers at Medicago Inc. in North Carolina produced in one month more than 10 million doses of an animal-model H1N1 flu-vaccine candidate based on virus-like particles, the DARPA statement said.
The work was part of a rapid-fire test that ran from March 25, 2012, to April 24, 2012, and showed that a single dose of the H1N1 vaccine candidate induced protective antibody levels in an animal model when combined with a standard immunological additive, according to DARPA.
The Texas A&M Center for Innovation has partnered with Caliber Biotherapeutics to make Calibers plant-made pharmaceutical facility available for HHS task orders, including vaccines, Giroir told the panel.
The facility has the capability to produce up to 20 kilograms of purified protein per month through its highly automated, Nicotiana benthamiana, a close relative of tobacco, plant-based production system, Giroir said.
We consider this program to be the most responsive, secure and capable plant-made vaccine program currently available worldwide, he added.
Giroir said the Center for Innovations high-level objectives are:
- To provide a national vaccine response against pandemic flu, defined as 50 million doses delivered in 4 months, with initial doses available to the federal government in 12 weeks;
- To perform what’s called advanced development – the final steps – in manufacturing vaccines and medical countermeasures against chemical, biological, radiological and nuclear threats as tasked by HHS; and
- To train the future domestic U.S. workforce.
To achieve these objectives, Texas A&M leads a multidisciplinary team with expertise that spans research to clinical trials, including GlaxoSmithKline, or GSK Vaccines, the world’s largest vaccine developer, Giroir said.
The center also is expanding domestic U.S. infrastructure, he added, building a new, dedicated pandemic flu vaccine facility to meet its 50-million-dose requirements, and building a new live-virus vaccine facility at biosafety level 3, designed specifically for research with hazardous biological agents.
Giroir said Texas A&M is highly motivated to continue its history of service to the nation by supporting DOD and supplying improved vaccines and countermeasures to the warfighter.
Of particular interest would be DOD partnerships to develop and manufacture products for their stockpile and special immunizations programs, he added, and perhaps more importantly, to be the cornerstone for an emergency response to genetically modified or chimeric organisms [and] other unexpected agents that we believe are a growing, real threat to our national security and public health.
Because the centers contract with HHS indicates that 50 percent of its capabilities are available for non-HHS projects, there is an immediate opportunity for DOD to use center capacity and expertise already funded by HHS, Giroir said.
We believe such collaborations would not only reduce DOD operational risks, he added, but would reduce DOD expenditures, potentially by hundreds of millions of dollars, that could then be reallocated to provide additional vaccines, countermeasures and capabilities to our war fighters.