Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional

Funding Agency:
National Institutes of Health

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.


  • Letter of Intent Due Date(s): April 1, 2019 for May 2019 application due date. For all subsequent application due dates, letter of intent will be due 60 days prior to the application due date.
  • Application Due Date(s):

    May 14, 2019, by 11:59 PM Eastern Time.

    April 4, 2020, by 11:59 PM Eastern Time.

    April 5, 2021, by 11:59 PM Eastern Time.

PAR-19-216 Expiration Date April 6, 2021

Agency Website

Amount Description

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $3,000,000

YR 02: $1,000,000

YR 03: $1,000,000

Funding Type





Medical - Translational

External Deadline

April 4, 2020