Institutions of higher learning entrusted with research
The U.S. Food and Drug Administration awarded three grants 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
“We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to accelerate the development of new therapies and reduce the cost of critical medicines. Continuous manufacturing utilizes technologies that offer clear benefits for both patients and industry. The approach has the potential to shorten production times and improve the efficiency of manufacturing processes,” said FDA commissioner Scott Gottlieb, MD.
Gottlieb added that he and the Administration recognize the important role they play in the process of making drugs safer, and that continued grants will be a considerable factor in reaching their shared goals.