August 1, 2018
“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. These benefits translate to lower cost of production and thus the cost of medicine. It also allows for more nimble monitoring and control that can help reduce the likelihood of manufacturing failures, which in turn can reduce the risk of drug shortages. Moreover, it has the potential to create more modern, domestically-based manufacturing by making it more feasible to manufacture these products on American soil. We recognize that FDA has an important role to play in advancing these opportunities. The agency is uniquely stationed to support the development of this technology to help improve patient care and facilitate greater access,” said Commissioner Scott Gottlieb, M.D. “We’re committed to taking steps to help reduce the cost and uncertainty of adopting this and other new manufacturing platforms. Toward these goals, we awarded nearly $6 million in grants to three world-class research institutions to study how cutting-edge manufacturing technologies can be implemented in a way that leads to more innovative, consistent and dependable manufacturing of drug and biological products. The grants are one element in FDA’s approach to encourage wider adoption of these technologies, and the FDA will continue to lead efforts to develop the standards, policy and guidance needed to support the effective and efficient adoption of these new manufacturing platforms.”
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.
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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.