Grants / Department of Health and Human Services / Food and Drug Administration

FOR-FD-21-007: AAV Vector manufacturing for diseases affecting very small populations

Closed Closed Opportunity FOR-FD-21-007 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2021.

• Award ceiling$600,000
• Total funding$3.0 million
• Expected awards5
• Cost sharingNot required
• Funding typeGrant

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $600,000 per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

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)

Category: Agriculture, Consumer Protection, Food and Nutrition.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.