CDER's Cutting-Edge Lab for Evaluating Innovative Drug Manufacturing Technologies
The Center for Drug Evaluation and Research’s (CDER) Advanced Manufacturing Research Facility (AMRF) is a new laboratory for evaluating innovative drug manufacturing technologies and ensuring drugs produced with these technologies are safe, effective, and high quality. CDER uses this facility to lead regulatory science research for current and new advanced manufacturing technologies and strengthen the agency’s connection between research, policy, and assessment.
Advancing Scientific Knowledge
CDER’s research at the AMRF will provide scientific knowledge for:
Developing future policies, including guidance for industry, or regulatory frameworks that encourage and support drug manufacturers’ broader use of advanced manufacturing technologies.
Training FDA staff on assessing drug applications and inspecting manufacturing facilities that use advanced manufacturing technologies.
CDER’s ability to quickly gain knowledge about advanced manufacturing technologies will provide CDER’s Framework for Regulatory Advanced Manufacturing Evaluation initiative and Emerging Technology Program with the latest regulatory science and enable CDER to encourage and support drug manufactures in adopting advanced manufacturing technologies.
Versatile Facility Design
The AMRF’s flexible design allows CDER to easily reconfigure the facility as needed to rapidly research regulatory science priorities. The AMRF is an 18,000 square foot state-of-the-art research space that will enable integrated, automated manufacturing platforms with online analytical measurements. It includes:
- Multi-use laboratory for various research needs.
- Analytical testing laboratory for rigorous evaluation and testing.
- Specialized laboratories focused on understanding the impact of emerging manufacturing technologies on the quality of solid oral dosage forms, complex drug products, active pharmaceutical ingredients, and biotechnology processes.
Learn More
CDER will provide updates on future AMRF activities when they are available. For more information or questions, contact OPQR-Ammendale@fda.hhs.gov.
