# AAV Vector manufacturing for diseases affecting very small populations

Source: https://welltoldgrants.com/grants/for-fd-21-007-aav-vector-manufacturing-for-diseases-affecting-very-small/  
Official notice: https://www.grants.gov/search-results-detail/331721

> Food and Drug Administration offered grants of up to $600,000 to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 5 awards worth $3.0 million in total. It is no longer open on Grants.gov.

| Field | Value |
|---|---|
| Opportunity number | FOR-FD-21-007 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | not set |
| Award ceiling | $600,000 |
| Award floor | not stated |
| Expected awards | 5 |
| Total funding | $3.0 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- 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
- For profit organizations other than small businesses
- Small businesses

## What the grant funds

CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. Such innovations include the definition of critical quality attributes of AAV as vectors for gene therapy, development of advanced process analytics, development of a of non-proprietary AAV vectors, and demonstration of low-cost, non-proprietary GMP manufacturing methods for AAV vectors. This research will advance innovative manufacturing of AAV vectors for gene therapy. CBER anticipates that addressing the need for gene therapy products for diseases affecting very small populations will also lead to technical developments that will advance the entire field of gene therapy. 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 therapies. Some specific areas of research could include the following, but applications should clearly describe the potential impacts of the proposed enabling technology on readiness for broad implementation in the biological product industry, and/or regulatory evaluation: • Definition of critical quality attributes of AAV vectors for gene therapy • Development of advanced analytics to enhance AAV vector manufacturing process knowledge and monitoring of critical quality attributes • Development of a non-proprietary suite of AAV vectors suitable for gene therapy applications for diseases affecting very small populations • Demonstration of the feasibility of low-cost, non-proprietary GMP manufacturing methods for AAV vectors at a scale appropriate for very small populations (one batch provides approximately 5-20 doses)

## Questions people ask

### Is FOR-FD-21-007 still open?

No. It is no longer open on Grants.gov. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for AAV Vector manufacturing for diseases affecting very small populations?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

### What is the deadline for AAV Vector manufacturing for diseases affecting very small populations?

Closed. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $600,000 each. About $3.0 million in total across about 5 awards.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.