DHHS: Offering Grants of up to $2,000,000 in US

Deadline: 18-May-21

The Department of Health and Human Services (DHHS), Food and Drug Administration and Center for Biologics Evaluation and Research (CBER) is inviting applications for Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines Against Influenza and Emerging Infectious Diseases.

CBER seeks to support the application of novel technologies for advanced manufacturing of complex biologic products, and innovative analytical approaches to improve product manufacturing and quality through active research. One such technology is continuous manufacturing, defined as manufacturing using a continuous process, rather than a batch-process approach.

This emerging technology has the potential to improve agility, flexibility, cost, and robustness in the manufacturing processes for complex biologics. In general, CBER seeks to enhance development of innovative technologies with the potential to address product shortages, improve product quality, and accelerate the time to market for complex biologics such as vaccines against influenza and other emerging diseases.

The supported research will advance innovations in manufacturing by developing and making technologies accessible to industry in the near term, and by bridging the gaps between discoveries and the implementation by industry. Additionally, this research is intended to support advances in regulatory science that allow for development of science and risk-based guidelines to facilitate faster adoption of these innovative technologies.

Some specific areas of research could include the following and the application should clearly describe the potential impacts of the proposed technology on the readiness for broad implementation in the biological product industry, control strategy, and/or regulatory evaluation:

Development of cell lines capable of significantly improving recombinant influenza hemagglutinin protein yields ≥ 50% over current methodologies
Development of improved bioreactor technologies for intensified biomanufacturing of high quality recombinant protein vaccines
Refinement of vaccine characterization technologies to facilitate more rapid production and lot release.

Funding Information

Estimated Total Program Funding: $2,000,000
Award Ceiling: $500,000
Award Project Period: The scope of the proposed project should determine the project period. The maximum project period is 3 years.

Eligibility Criteria

Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
  - Hispanic-serving Institutions
  - Historically Black Colleges and Universities (HBCUs)
  - Tribally Controlled Colleges and Universities (TCCUs)
  - Alaska Native and Native Hawaiian Serving Institutions
  - Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations