OCET Advanced Manufacturing
Advanced manufacturing technologies can improve drug quality, address shortages of medicines, and speed time-to-market. The goal of the Office of Counterterrorism and Emerging Threats (OCET) Advanced Manufacturing Program is to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience.
In This Section
![Robot arm and human hand meet, with gears, representing the concept of advanced manufacturing](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-about2-1600x900.jpg?itok=2Xcqryob)
About the OCET Advanced Manufacturing Program
Supporting research and adoption of advanced manufacturing technologies and platforms that can be used in multiple FDA-regulated product areas
![People collaborating near a white board with multiple charts](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-projects-1600x900_0.jpg?itok=R5k2U2IR)
Research and Projects
FDA intramural and extramural projects to support adoption of advanced manufacturing technologies
![Professionals collaborating in an office](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/innovation-hub-1600x900.png?itok=BsanHA3w)
I-TEAM Hub
A collaboration with HHS/ASPR to create a space for technology innovation and collaboration
![Image illustrating the concept of advanced manufacturing for medical products](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-about-1600x900.jpg?itok=Sr0h-XgJ)
Advanced Manufacturing Public-Private Partnerships
FDA participates in public-private partnerships to proactively address challenges presented by advanced and continuous manufacturing technologies
![An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/Advanced_mfg_Drupal_1600px_sm.jpg?itok=uhKVvpUy)
About Advanced Manufacturing and Public Health Emergencies
Advanced manufacturing is a collective term for new technologies that can improve drug quality, address shortages, and speed time-to-market
Featured Projects
![Smart Design and Manufacturing Pilot concept image](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-pilot-1600x900.jpg?itok=HxpP44R6)
Smart Design and Manufacturing Pilot
Pilot program to provide a smart (digital) design and automated manufacturing production demonstration software package and conveyor line
![Advanced manufacturing images, including work in a lab](https://public4.pagefreezer.com:443/content/FDA/13-03-2024T15:34/https://www.fda.gov/files/styles/medium_3/public/adv-manufacturing-nist-1600x900.jpg?itok=9uQQpGX7)
Initiative to benchmark and profile monoclonal antibody and large biomolecule s…
FDA is partnering with NIST to develop and benchmark methods to study and predict stability of monoclonal antibodies