The goals of the FDA Office of Counterterrorism and Emerging Threats OCET Advanced Manufacturing Program focus on increasing the adoption of advanced manufacturing through innovative regulatory science, increased FDA training, and increased visibility of advanced manufacturing technologies to external stakeholders.
Rapidly scale manufacturing capabilities for vaccines and other medical countermeasures (MCMs) to respond faster to emerging threats and other public health emergencies, such as pandemic influenza
Shorten supply chains and increase manufacturing resilience to disruption by emerging threats or public health emergencies, such as natural disasters
- For instance: creating a distributed network of small manufacturing sites that can provide reserve capacity for centralized manufacturing facilities
- These technologies for monitoring and increasing supply chain resilience can be implemented across the spectrum of regulated products (e.g., food, drugs, devices, vaccines)
- Accelerate therapy development for orphan diseases by improving the cost-efficiency of small-scale manufacturing processes
- Speed availability of emerging therapies by enabling manufacturing process and standards development, including for cell and gene-therapies, supporting goals of the 21st Century Cures Act (Cures Act)
- Provide new tools to address drug and device shortages and other challenges, including medical product quality
FDA supports and conducts research to further advanced manufacturing technologies, and the evaluation of products manufactured using these technologies. Ways we do this include in-house 3D printing facilities, an advanced manufacturing innovation hub, supporting academic programs, engaging in public-private partnerships, and funding intramural and extramural research.
External programs such as the Centers of Excellence in Regulatory Science and Innovation (CERSI), the Broad Agency Announcement (BAA), and other contracting mechanisms allow FDA to fund external academic, public health, and industry researchers and experts to find and address gaps in our regulatory science knowledge. More information about funding opportunities is available on our Advanced Manufacturing News and Events page. Each center also supports programs that focus on their specific product portfolios.
Many U.S. universities have established advanced manufacturing academic programs. Some of which are funded through FDA grants. For example, FDA has awarded grants, using Cures Act authorities, to institutions of higher education and nonprofit organizations to study and recommend improvements for the continuous manufacturing of drugs and biological products, as well as similar innovative monitoring and control techniques.
To proactively address challenges presented by advanced and continuous manufacturing technologies, FDA representatives actively participate in ongoing public-private partnerships. These partnerships include U.S. government agencies, academia, research institutes, and industry. Examples of these partnerships include federally supported advanced development and manufacturing centers, the Manufacturing USA Institutes, and America Makes.
OCET-supported projects currently in progress include:
|Project / description
|Smart Design and Manufacturing Pilot - To provide a smart design and manufacturing demonstration line, complete with a suite of manufacturing, development, and modeling software, miniature assembly line, online sensors and measurement tools, and user stories that show the implementation of a fully digital product lifecycle implementation
|Siemens Government Technologies (co-funded by CDRH)
|June 2021 - March 2023
|FDA contract 75F40121P00294
|Initiative to benchmark and profile monoclonal antibody and large biomolecule stability, in an effort to ease supply chain burdens and facilitate use during pandemic response.
|National Institute of Standards and Technology (NIST)
|September 2022 - September 2023
Projects in this list were funded by OCET.
|Project / description
|Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products
|MxD (The Digital Manufacturing and Cybersecurity Institute) and IAAE
|July 2020 - June 2021
|FDA contract 75F40120P00303
|Assessing the Role of Additive Manufacturing in Support of the U.S. COVID-19 Response
|America Makes, National Center for Defense Manufacturing & Machining
|September 2020 - February 2021
|FDA contract 75F40120P00531
FDA’s Additive Manufacturing of Medical Products (AMMP) core research facility is a multi-center collaboration. It augments center-specific resources and houses high-end, industry-grade 3D printing equipment, software, and expertise that can be used across FDA to perform cutting-edge regulatory research with this advanced technology.
The AMMP Lab will establish a scientific foundation to assist FDA with its assessment of advanced manufacturing, and provide the critical infrastructure the agency will need to meet the regulatory demands of the future. FDA’s in-house 3D printing facilities enable FDA scientists to develop standards and metrics for use of 3D printing for medical products; conduct research to determine how the 3D printing of drugs impacts active and inactive drug components; and identify critical quality processes and controls that affect the safety and performance of drugs and devices.
Focus Areas of Regulatory Science (FARS)
The Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Advanced manufacturing is a priority area, under the focus area “Increasing Choice and Competition Through Innovation.” Please contact FARS@fda.hhs.gov with questions about this initiative.
More from FDA:
- 3D Printing of Medical Devices (CDRH)
- Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins (CDER)
- CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals (CDER)
- Impact Story: Regulatory Science is Strengthening U.S. Drug Product Manufacturing (CDER)
- Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing (CDER)