Washington, DC - The U.S. Food and Drug Administration awarded three grants, using its authority under the 21st Century Cures Act, to institutions of higher education and non-profit organizations to study and recommend improvements for the continuous manufacturing of drugs and biological products, as well as similar innovative monitoring and control techniques. The grant awardees are:

  • Rutgers University (Piscataway, N.J.), Industry 4.0 Implementation in Continuous Pharmaceutical Manufacturing—$2,004,790
  • The Massachusetts Institute of Technology (Cambridge, M.A.), Smart Data Analytics for Risk Based Regulatory Science and Bioprocessing Decisions—$2,996,875
  • Georgia Institute of Technology (Atlanta, G.A.), Continuous Synthesis, Crystallization, and Isolation (CSCI) of an API: Process Model-Controlled Enzymatic Synthesis of Beta-Lactam Antibiotics—$982,869

The FDA’s Emerging Technology Program, was established to help industry implement innovative technologies to improve product quality and modernize the industry. Under this program, the FDA engages with industry early in their process of developing new technology, and discusses and helps resolve any anticipated regulatory or scientific issues prior to the submission of product applications. Many companies have applied to the Emerging Technology Program regarding continuous manufacturing, which has enabled the FDA to quickly review and approve applications involving continuous manufacturing operations. The FDA guidance document, Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization, provides information and advice about how to work with the agency early in the development process.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.