FDA Awards Research Grants in Continuous ManufacturingBy
The US Food and Drug Administration (FDA) has awarded a total of $6 million to three universities to study and recommend improvements for continuous manufacturing for drug substances and drug products. The awardees are Rutgers University, The Massachusetts Institute of Technology (MIT), and the Georgia Institute of Technology (Georgia Tech).
“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,” said FDA Commissioner Scott Gottlieb in an August 1, 2018 agency statement. “Continuous manufacturing utilizes technologies that offer clear benefits for both patients and industry.…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.” Gottlieb also explained that continuous manufacturing can help reduce the likelihood of manufacturing failures and therefore, reduce the risk of drug shortages.
The FDA made the awards under its authorization from the 21st Century Cures Act, which was signed into law in 2016 and is designed to help accelerate medical product development. Its authorization allows 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 grants are to: Rutgers University (approximately $2.0 million) for “Industry 4.0 Implementation” in continuous pharmaceutical manufacturing; MIT (approximately $3.0 million) for smart data analytics for risk-based regulatory science and bioprocessing decisions; and Georgia Tech (approximately $1 million for continuous synthesis, crystallization, and Isolation of an active pharmaceutical ingredient, specifically process model-controlled enzymatic synthesis of beta-lactam antibiotics.
The FDA has been increasing its support of new technology, such as continuous manufacturing, by helping industry companies learn how to implement them. The FDA established its Emerging Technology Program in 2017 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. The agency says 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.