Advancing Manufacturing Processing and Control Strategies for Drug...
The goal of this program is to support the advancement of regulatory science to facilitate the implementation and the assessment of continuous manufacturing and similar innovative monitoring and control techniques in the pharmaceutical sector. This will be accomplished by making awards to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products (e.g., monoclonal antibodies and therapeutic enzymes). Examples of activities could include the development or modification of a novel manufacturing process (e.g., design, scale-up, and/or commercial scale), control method, and/or testing technology. Awards made under this FOA may be funded in part by appropriations received under the 21st Century Cures Act, section 3016. Cooperative Agreement
- Public and State controlled institutions of higher education
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Private institutions of higher education