AAV Vector manufacturing for diseases affecting very small populations

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Opportunity ID:331721
Opportunity Number:FOR-FD-21-007
Opportunity Title:AAV Vector manufacturing for diseases affecting very small populations
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Grant
Category of Funding Activity:Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
CFDA Number(s):93.103
Eligible Applicants: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
Additional Information on Eligibility:
Agency Code:HHS-FDA
Agency Name:Department of Health and Human Services
Food and Drug Administration
Posted Date:Feb 24, 2021
Last Updated Date:Feb 24, 2021
Estimated Synopsis Post Date:
Fiscal Year:2021
Award Ceiling:$600,000
Award Floor:
Estimated Total Program Funding:$3,000,000
Expected Number of Awards:5
Description: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)
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