September 20, 2018
“Advanced manufacturing technologies, such as continuous manufacturing, hold great promise for improvements in the reliability, flexibility and cost effectiveness of manufacturing for biological products. These platforms may be critical to unlocking the full potential of very novel technologies like cell and gene therapies, and new vaccines. Grants like these help encourage the establishment of high tech manufacturing platforms in the U.S., potentially providing an opportunity to bring more manufacturing back to American soil,” said Commissioner Scott Gottlieb, M.D. “The FDA is uniquely positioned to help support these technologies and scientific advances, in part by bridging the gap between the development of the enabling technologies that give rise to these platforms and their advancement and implementation by industry partners. As part of these efforts, the agency is committed to supporting advances in regulatory science that can help inform our risk-based guidelines and facilitate faster adoption of innovative technologies, while ensuring the safety and efficacy of biological products. Today, we awarded nearly $3 million in grants to five globally-recognized research institutions to study ways in which cutting-edge manufacturing technologies can be implemented to advance these goals, and enable more innovative, consistent and dependable manufacturing of biological products.”
The U.S. Food and Drug Administration awarded five grants, using its authority under the Federal Food, Drug and Cosmetic Act added by the 21st Century Cures Act, to institutions of higher education and non-profit organizations to study and recommend improvements for the continuous manufacturing of biological products, as well as similar innovative monitoring and control techniques. The grant awardees are:
- Harvard University (Cambridge, MA), antigen-presenting cell mimetic scaffolds for expansion of higher quality therapeutic T-cells - $599,910
- Carnegie-Mellon University (Pittsburgh, PA), addressing key manufacturing needs for extracellular matrix scaffold 3D printing - $599,844
- Rutgers University (Piscataway, NJ), develop and implement a platform technology-based testbed of a fully automated and integrated continuous upstream bioprocess - $600,000
- Georgia Institute of Technology (Atlanta, GA), data enabled automation for the improved efficacy, yield and reproducibility of the manufacturing of mesenchymal stromal cells for clinical therapeutic use - $600,000
- Massachusetts Institute of Technology (Cambridge, MA), continuous viral vector manufacturing cased on mechanistic modeling and novel process analytics - $600,000
The FDA recognizes that the implementation of emerging technologies for manufacturing high-quality complex biologics could present a variety of challenges. However, there may be a limited knowledge and experiential base about the technology by the very fact that an approach is new or innovative.
These grants aim to address knowledge and experience gaps identified for emerging manufacturing technology and support the development and adoption of such technology in the biological product sector. The agency will continue to support efforts to develop the standards, policies and policy guidance needed to foster the effective and efficient development and adoption of new manufacturing platforms.
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.