The onset of the COVID-19 pandemic caused severe shortages of medical personal protective equipment (PPE) in the U.S. The advanced manufacturing sector was at the center of the U.S. response, acting as a catalyst to help re-invent the PPE domestic supply chain and playing a major role in the development, production and distribution of diagnostics, vaccines and therapeutics.
The advanced manufacturing sector must continue to be at the center of a coordinated U.S. response to future pandemics, and the innovation institutes in the Manufacturing USA network are well positioned to continue their leadership.
Sixteen manufacturing innovation institutes and their sponsoring federal agencies — the Departments of Commerce, Defense and Energy – make up the Manufacturing USA network. Manufacturing USA was created in 2014 to secure U.S. global leadership in advanced manufacturing. Many of these institutes are engaged in reshaping the PPE supply chain and have received CARES Act funding to prepare the nation for future emergency responses.
One of the institutes led the effort to create a roadmap to inform industry stakeholders on how to better respond to the next global outbreak, and several institutes have developed platforms for resources, processes and opportunities that will enable the U.S. response to future pandemics.
The profound loss of life and steep social and economic costs of the COVID-19 pandemic have underscored the pressing need for increased preparedness and resiliency across all public and private sectors. A key goal of the roadmap was to prepare stakeholders to identify threats at the earliest possible stage and to prevent pitfalls that could result from a lack of cooperation and an uncoordinated response.
A faster and more coordinated response could greatly reduce public health and economic impacts in five major ways:
- Addressing the initial spread of disease
- Accelerating identification, testing, and regulatory review of potential treatment and vaccines
- Equipping medical staff to safely and effectively treat patients
- Enabling rapid production and delivery
- Supporting and augmenting the healthcare workforce
BioFabUSA, the Advanced Regenerative Manufacturing Institute, was instrumental in creating the National Technology Roadmap for Pandemic Response and Recovery. The roadmap aims to increase U.S. preparedness and resiliency through predictive capabilities and the strategic planning and collaboration of organizations, from R&D, to commercialization and the supply chain.
In the early stages of the COVID-19 pandemic, BioFabUSA and the Nexight Group brought together more than 75 experts from academia, industry, government, nonprofits and consortia to create the roadmap. The fields represented were:
- Data science
- Data security
- Manufacturing for medical devices
Using lessons learned from COVID-19, the roadmap outlines how such an improved response can be achieved through investment in technologies, platforms, and infrastructure improvements in six key technical focus areas:
- Supply Chains — to ensure access to all raw materials and components needed for manufacturing
- Manufacturing — to meet demands for PPE, medical devices, therapeutics and vaccines, both rapidly and flexibly
- Deployment and Access — to ensure products and support are available when and where they are needed most
- Data Infrastructure — to help inform public health response decisions
- Predictive Capabilities — to enhance early detection and tracing, prediction of new outbreaks, prediction of prognosis, drug development, and vaccine design
- Regulatory Processes — to facilitate the accelerated approval of safe and effective medical products critical to pandemic response
The roadmap intends to help not only organizations involved in pandemic response and recovery, but also those in technology sectors that will play a role in building capacity and resiliency for future pandemics. For each area, the roadmap recommends specific technology development and commercialization efforts that can be implemented immediately to respond to COVID-19, as well as longer-term research and development priorities needed to improve readiness for future pandemics. For example, the regulatory process traditionally has been a slow one, but the roadmap suggests it doesn’t have to be if you can de-risk some processes by doing them in parallel.
Institutes in the Manufacturing USA network are involved in scores of projects that will enhance the response to the future pandemics. Here are highlights of a handful of those projects.
Advanced Functional Fabrics of America (AFFOA) institute is leading a project with about a dozen stakeholders to develop a blueprint to assist domestic manufacturers to rapidly pivot their production lines and produce PPE products or necessary materials. AFFOA is providing project product management and oversight for:
- Supply vs. Demand Estimation: Developing a tool to predict future PPE demand during surge events. The tool predicts demand at hospitals, long-term care, first responders and home health care settings.
- Supply Chain Mapping: Researching and assembling a supply chain map of domestic PPE manufacturers. This effort has resulted in the identification of over 120 U.S. companies manufacturing materials and products throughout the PPE supply chain.
- PPE Product Testing: This additional PPE testing infrastructure enabled the quick identification of poorly performing products, ensuring only properly-performing PPE was distributed to front-line workers, as well as allowing domestic manufacturers to design and produce high quality U.S.-made PPE products more quickly.
- Product Design & Technical Data Packages: This project has validated the manufacturability of PPE designs, ensuring these products can be efficiently manufactured by domestic producers.
- Alternative Sourcing of Raw Materials: One of the major reasons for the shortage of respiratory PPE at the beginning of the pandemic was a scarce supply of meltblown polypropylene nonwoven material. To solve this challenge, project stakeholders developed alternative materials and manufacturing processes that performed as well or better for critical filtration, product decontamination and reuse.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in December awarded 32 coronavirus response projects to multiple organizations across the U.S. funded through the American Rescue Plan. This is in addition to a major initiative to build an end-to-end manufacturing test bed for biopharma companies, universities and government collaboration.
Thirteen major pharmaceutical companies are working with NIIMBL and its partners to develop a process for faster and more flexible approaches to manufacturing vaccines using continuous manufacturing. This test bed housed at the University of Delaware will be the foundation for future flexible manufacturing facilities’ rapid response to pandemics and also bolster domestic manufacturing capabilities. The uniquely collaborative shared environment between companies, universities, and federal agencies that is the hallmark of the innovation institutes aims to revolutionize continuous manufacturing of medicines – often considered too risky for any one company to pursue.
BioFabUSA is overseeing a project that will develop a system for the rapid scaling of cell-based therapies for emergency responses. Many living cell-based treatments require rapidly deployable production of clinical samples for emergency use approvals, which is beyond the capacity of most product developers.
While the immediate focus of the program is to respond to the ongoing COVID-19 health crisis, the platform will be uniquely placed to provide scalable surge capacity for either allogeneic or autologous cell-based drug products for use in future pandemic crises and for other current infectious diseases. Allogeneic therapies are manufactured in large batches from unrelated donor tissues (such as bone marrow) whereas autologous therapies are manufactured as a single lot from the patient being treated.
Advanced Robotics for Manufacturing Institute (ARM) and two of its partners have addressed the urgent need to rapidly deploy additional facilities in emergency situations by creating a robotic solution to quickly stand up overflow structures. These air-supported structures are rapidly deployable with performance advantages over traditional tents, and are ideal for use as expeditionary hospitals, quarantine facilities, housing, and other disaster relief or military applications. But production of these structures is labor-intensive.
ARM Institute and its partners developed a fleet of human-directed robotic platforms to take on the hard work of moving the material around the production floor, aiding manufacturing personnel. This solved the problem of moving and manipulating a large, heavy, flexible material over a large area. As a result, Air Structures American Technology Inc. has produced a “hospital in a shipping container” that can be set up in a parking lot in only 72 hours with a crew of 8 to 10 and a forklift. This will reduce cost and manufacturing lead times of these critical structures.
The American Institute for Manufacturing Integrated Photonics (AIM) worked with five of its partners to create an optical chip on a disposable card that can detect exposure to multiple viruses within a minute from a single drop of blood. The integrated technology application has proven to be better, faster and cheaper than alternatives.
The availability of rapid COVID-19 antibody tests is important for assessing vaccine performance. When combined with a commercial high-volume clinical analyzer, this card results in functional point-of-care testing. The test enables clinicians not only to detect and study COVID-19, but also to better understand potential relationships between COVID-19 infection and previous infections and immunity to other respiratory viruses, including circulating coronaviruses that cause the common cold. The test is designed to address ongoing needs including vaccine response and immunity to mutant COVID-19 strains.
The National Technology Roadmap for Pandemic Response and Recovery and the innovation institutes demonstrate the perspective that must form the core of a response and recovery strategy for future pandemics. Institutes in the Manufacturing USA network have shown how effective manufacturing and supply chain networks can drive down response time on everything from PPE to vaccine development and delivery. Their work is helping position the domestic advanced manufacturing sector for a more effective response to future pandemics.
About the institutes: In 2020, 16 institutes in the Manufacturing USA network collectively worked with over 2,000 member organizations to collaborate on more than 500 major research and development projects and engaged over 70,000 people in building workforce knowledge and skills in advanced manufacturing. State, industry and federal funds contributed $400 million to these activities.
To learn more about how the manufacturing innovation institutes responded to the COVID-19 pandemic, visit the Institutes’ page