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Advanced Manufacturing

Innovations in advanced manufacturing support public health emergency preparedness and response. Learn more about FDA's advanced manufacturing activities.

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An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)
Caption
An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)

On this page: What's new | What is advanced manufacturing? | FDA's role | Science and research | Guidance for industry | More information from FDA | Additional resources | Contact FDA

What's new

What is advanced manufacturing?

Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Every field has a different set of production techniques that are considered advanced. They often:

  1. Integrate novel technological approaches
  2. Use established techniques in a new or innovative way, or
  3. Apply production methods in a new domain where there are no defined best practices or experience.

Examples of some cross-cutting advanced manufacturing technologies include continuous manufacturing and 3D printing.

FDA's role

FDA is taking many steps to help realize the potential of advanced manufacturing, including:

  • Issuing guidance on emerging technologies and working with medical product sponsors to clarify regulatory and data requirements necessary to support product applications using advanced manufacturing technologies - Also see Guidance for industry below
  • Reviewing and approving medical products that are made with continuous manufacturing technologies (e.g., New Drug Applications and Biologics License Applications)
  • Advancing regulatory science to proactively address regulatory challenges presented by advanced and continuous manufacturing technologies - Also see Science and research below

3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is spurring innovation in manufacturing. In December 2017, FDA became the first regulator worldwide to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

Also see: The 3Rs of 3D Printing: FDA's Role

Science and research

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

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 the Agency to perform cutting-edge regulatory research with this advanced technology.

The AMMP Lab will establish a scientific foundation to assist the Agency with its assessment of advanced manufacturing, and provide the critical infrastructure FDA 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.

Academic programs

Many U.S. universities have established advanced manufacturing academic programs. Some of which are funded through FDA grants. For example, in August and September 2018, FDA awarded a total of eight 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.

Public-private partnerships

FDA representatives actively participate in ongoing public-private partnerships to proactively address regulatory challenges presented by advanced and continuous manufacturing technologies. 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. Also see: FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership

Funding opportunities

FDA funding

FDA funds research and development to support regulatory science and innovation under the FDA Broad Agency Announcement (BAA). Advanced manufacturing opportunities may be submitted in areas of interest including:

  • 3.0 Support New Approaches to Improve Product Manufacturing and Quality (examples)
  • 7.0 Facilitate Development and Availability of Medical Countermeasures (MCMs) to Protect Against Threats to U.S. and Global Health Security (examples)

For more detail, and information on funding deadlines for the current fiscal year, see Extramural Research

Other funding

Guidance for industry

Recently updated guidance documents specific to advanced manufacturing include:

Search the complete list of FDA guidance

More information from FDA

Emerging Technology Program

FDA established an Emerging Technology Program in 2014 that works collaboratively with companies to support the adoption and use of advanced manufacturing for both new and existing drugs. The team assists companies that want to implement innovative technology, including continuous manufacturing, by helping them to identify and resolve potential scientific and regulatory challenges and providing guidance to their technology development and implementation.

 

FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing. Video transcript

CBER Advanced Technologies Program

In 2019, the FDA Center for Biologics Evaluation and Research (CBER) established the CBER Advanced Technologies Team (CATT) to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies that are intended to be implemented in CBER-regulated products.

3D printing links

 

Learn how FDA works with 3D printing for innovative research and regulation.

Other related links

Press, statements, and publications

Events

  • May 15, 2020: Virtual Town Hall - 3D Printed Swabs, 1:00 - 2:00 p.m. ET - will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.  This is a collaboration between the FDA, the Department of Veterans Affairs’ (VA) Innovation Ecosystem, and the National Institutes of Health’s (NIH) 3D Print Exchange.
  • March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of advanced manufacturing technologies and methodologies, and discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
  • March 19, 2019: Nondestructive Analytics for Biologics and Continuous Biomanufacturing lecture recording, presented by Bruce Yu, PhD, Professor, Pharmaceutical Sciences and Director, Bio- and Nano-Technology Center, University of Maryland School of Pharmacy - In this CERSI lecture, Dr. Yu provided background on a nondestructive analytical technology, Water proton NMR (wNMR), discussed examples of applying wNMR to inspect FDA-approved biologics (vaccines, vaccine adjuvants, and a therapeutic protein) and a non-biologic complex drug (Ferrlecit), and described how wNMR can be used to improve continuous biomanufacturing.
  • March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology  (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of these advanced manufacturing technologies methodologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
  • October 10, 2018: Manufacturing USA: Securing U.S. Global Leadership in Advanced Manufacturing, hosted by the House and Senate Manufacturing Caucus, and sponsored by American Society for Mechanical Engineers
  • July 30-31, 2018: Continuous Manufacturing for the Modernization of Pharmaceutical Production, co-hosted by FDA and BARDA, with the National Academies of Sciences, Engineering, and Medicine, to discuss the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics (e.g., enzymes, monoclonal antibodies, and vaccines) and discuss specific challenges for process integration across the manufacturing system
     

Additional resources

Contact FDA

Consumers and general information

Call 1-888-INFO-FDA (1-888-463-6332), or contact the FDA center or office related to your inquiry.

Press

Office of Media Affairs: Email fdaoma@fda.hhs.gov or call 301-796-4540

Industry

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