This Foundry for American Biotechnology will be housed in Manchester, New Hampshire, and managed in conjunction with the Advanced Regenerative Manufacturing Institute (ARMI), led by Manchester-based DEKA Research Corp., as part of a public-private partnership with HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).  No longer does America produce usable products for Americans rather it is engaging in biofabrication. 

Significant breakthroughs in cell biology, biofabrication and materials science in the last decade have laid the foundation for large-scale manufacturing and commercialization of engineered tissues and tissue-related technologies, including tissues- and organs-on-chip. However, the tissue engineering field is fragmented and lacks a mechanism with which to turn laboratory breakthroughs into manufactured products. Therefore, the nation needs an industrial commons, in the form of a Manufacturing Innovation Institute (MII) within the Manufacturing USA network, in which to coalesce the field and provide a route for nascent product concepts to reach the marketplace. Bringing these products to the market will benefit critical U.S. public health needs and will provide the economic drivers needed to create new highly-skilled jobs.

ASPR and a consortium of government agencies and private sector partners will determine, fund, and attract additional private sector funding to commercialize the foundry's innovation projects. In addition to ASPR and ARMI, the first consortium partners will include representatives from industrial pharmaceutical and industrial automation sectors.

"As the outbreak of the novel coronavirus reminds us, protecting the health and security of the American people requires constantly investing in biotechnology innovation and partnering with the private sector," said HHS Secretary Alex Azar. "The creation of the first Foundry for American Biotechnology in New Hampshire is a milestone achievement in the innovative work that ASPR has done to support America's development and manufacturing of medical countermeasures. Every year, America faces natural disasters and other public health emergencies, and some day, Americans will be able to recover faster from these emergencies and stay healthier because of products that come out of this Foundry."

"The Foundry for American Biotechnology represents a game-changer in driving technologies critical to saving lives in disaster response," said ASPR Dr. Robert Kadlec. "By providing essential services that move biotechnology from bench to bedside, the foundry not only solves problems the nation faces in health security, but also boosts the U.S. bioeconomy."

The Foundry will engage regional experts and offer an idea lab, dry and wet labs, manufacturing space, and a learning zone with access to DEKA's industrial design capabilities and the company's modeling and simulation technology. The Foundry also will create and manage a commercialization program that engages private-sector partners to accelerate the adoption of the technologies.

With this approach, technology more quickly becomes part of daily medical care and available for disaster response. This commercialization program also may reduce the need for federal and state governments to maintain costly stockpiles of medications, vaccines, diagnostics, equipment, and supplies.

The flexible wet lab space can be sized for specific project needs with project teams bringing their own personnel, products, materials, and supplies. The space even supports development of manufacturing processes using commercial Good Manufacturing Practices (cGMP) necessary to bring the products to market under the auspices of the United Nations. Under the partnership agreement announced today, DEKA also will offer its rapid prototyping capabilities to foundry projects.

The Foundry's first project will focus on maturing and validating small, portable, automated devices that could be transported easily to disaster locations to make necessary medicines on-site. ASPR is partnering with the Defense Advanced Research Projects Agency (DARPA ) to transition this technology to the Foundry from DARPA's Battlefield Medicine and Make-It programs.

"The DARPA partnership with ASPR is poised to provide the initial demonstration of automated, on-demand capabilities for distributed production of medicines, an important enabling capability for both the military and civilian sectors," said Anne Fischer from DARPA's Defense Sciences Office. "We are excited to work with ASPR at the Foundry to validate these critical technologies for production of medicines."

DARPA has been involved in:

• Discovering and leveraging novel findings from biotechnology, biochemistry, molecular biology, neuroscience, psychology, cognitive science, and related disciplines to advance treatment and resilience in neurological health and optimize human performance.
• Understanding and improving interfaces between the biological and physical world to enable seamless hybrid systems.
• Leveraging and translating a biological system’s underlying design rules, functional processes, and/or means of interactivity to macroscale systems.
• Developing new tools and capabilities for forward engineering of biological systems, such as cells, tissues, organs, organisms, and complex communities, to both develop new products and functional systems, as well as to gain new insights into underlying mechanisms.
• Developing new platform technologies that integrate, automate, and miniaturize the collection, processing, and analysis of biological and chemical samples.
• Developing technologies that leverage ecological diversity and/or help support human operations in extreme environments (e.g., ocean, desert, space, Arctic).
• Developing and validating new theories and computational models that identify factors and principles underlying collective and interactive behaviors of biological organisms at all scales from individual cells to global ecosystems.
• Understanding the dynamics of population and ecosystem behavior to preserve equilibrium, provide strategic opportunity, or avoid catastrophe.
• Developing and leveraging new technologies that can be applied to agricultural ecosystems for production stabilization, by improving quality or reducing losses from pathogens or pests.
• Developing and leveraging new insights into non-human biology across and between populations of microbes, insects, plants, marine life, and other non-human biologic entities.
• Developing technologies to leverage biological systems and enhance the ability to acquire and maintain critical and strategic organic and inorganic materials.
• Developing new technologies and approaches that ensure biosafety, biosecurity, biological cybersecurity of biological hardware, data, and information, and protection of the bioeconomy.
• Understanding emerging threats to global food and water supplies and developing countermeasures that could be implemented on regional or global scales.
• Developing new technologies to treat, prevent, and predict the emergence and spread of infectious diseases that have the potential to cause significant health, economic, and social burden.
• Developing and leveraging technologies to advance continuous or near-continuous monitoring of an organism’s physiology to elucidate mechanisms of human resilience.
• Developing new technologies for the rapid manufacturing, delivery and distribution of large molecule drugs such as biologics.
• Employing novel applications of biological components in historically engineered military systems.
• Developing an understanding of mechanisms that organisms use to assess and interact with their environment.
• Other biological technology topic areas that fit the national security

This effort is expected to boost ASPR's Priority Medicines on Demand program. In a disaster response, such as a pandemic or bioterrorism incident, millions of people may need medicines, such as antibiotics or antivirals, or vaccines. Through the Priority Medicines on Demand program, ASPR envisions producing essential products quickly in the location where they would be needed rather than being manufactured elsewhere in the country or the world, and shipped to the affected area.

"In a global health emergency like a pandemic, the countries in which active pharmaceutical ingredients, medications, and vaccines are produced could require manufacturing companies to provide the medications or vaccines to their own country before manufacturing and delivering products to other countries," Joe Hamel, ASPR's Strategic Innovation and Emerging Technology Manager explained. "Medicines on demand technology eliminates this complication, which would greatly decrease our emergency response time and help secure the U.S. supply chain."

The technology for medicines on demand have commercial uses as well. Technologies developed at the foundry could transition to the private sector or federal agencies for final development and technology validation, with sustainable products for sale on the commercial market.

Innovators interested in using the Foundry can learn more about the current problems ASPR is looking to solve.

About HHS, ASPR, and DARPA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal government's healthcare and public health preparedness, response, and recovery efforts.

For sixty years, DoD's DARPA has held to a singular and enduring mission: to make pivotal investments in breakthrough technologies for national security. Working with innovators inside and outside of government, DARPA has repeatedly delivered on that mission, transforming revolutionary concepts and even seeming impossibilities into practical capabilities. The ultimate results have included not only game-changing military capabilities such as precision weapons and stealth technology, but also such icons of modern civilian society such as the Internet, automated voice recognition and language translation, and Global Positioning System receivers small enough to embed in myriad consumer devices.

God Bless you from the trenches.  Be safe everyone.

Celeste

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Celeste has worked as a contractor for Homeland Security and FEMA. Her training and activations include the infamous day of 911, flood and earthquake operations, mass casualty exercises, and numerous other operations. Celeste is FEMA certified and has completed the Professional Development Emergency Management Series.

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Celeste also has training and expertise in small agricultural lobbying, Integrative/Functional Medicine, asymmetrical and symmetrical warfare, and Organic Farming.

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