The FDA is offering a grant to investigate the peptide-polymer interaction in poly(lactide-co-glycolide) (PLGA) microspheres used for controlled release of peptide drugs. The study aims to develop an approach to analyze different interactions, quantify degradation impurities, and understand the factors influencing peptide-polymer interaction. The findings will enhance the understanding of peptide-polymer interactions in drug delivery systems, aiding in the evaluation of generic microspheres with peptide drugs.
Opportunity ID: 282325
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-012 |
| Funding Opportunity Title: | Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 17, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 20, 2016 |
| Current Closing Date for Applications: | May 20, 2016 |
| Archive Date: | Jun 19, 2016 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments 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 Private institutions of higher education City or township governments Independent school districts Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Public and State controlled institutions of higher education State governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organization are not eligible to apply. Foreign components, are not allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Although biodegradable poly(lactide-co-glycolide) (PLGA) polymers have been utilized extensively for the controlled release of peptide drugs, there is still a lack of in-depth understanding of peptide-polymer interaction in PLGA based microspheres. The purpose of the present study is to develop a systematic approach to assess the peptide-polymer interaction in PLGA based microsphere dosage forms. The developed approach should be able to identify the different types of peptide-polymer interactions, characterize and quantify related peptide degradation impurities (e.g., acylation peptide adducts), and determine the formulation parameters, hydration and degradation factors, and manufacturing processes responsible for facilitating peptide-polymer interaction. The results from this study will provide better understanding of peptide-polymer interaction in PLGA based drug delivery systems, which will help the Agency in developing recommendations for evaluation of generic microspheres containing peptide drugs. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-012 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Eric Bozoian
Grants Management Specialist Phone 2404027623 Email:eric.bozoian@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Eric Bozoian Grants Management Specialist Phone 2404027623 Email: eric.bozoian@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00221681 | Mar 21, 2016 | May 20, 2016 | View |
Package 1
Mandatory forms
282325 RR_SF424_2_0-2.0.pdf
282325 PHS398_CoverPageSupplement_3_0-3.0.pdf
282325 RR_OtherProjectInfo_1_3-1.3.pdf
282325 PerformanceSite_2_0-2.0.pdf
282325 RR_KeyPersonExpanded_2_0-2.0.pdf
282325 RR_Budget_1_3-1.3.pdf
282325 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282325 RR_SubawardBudget30_1_3-1.3.pdf
282325 PHS_Inclusion_Enrollment_Report-1.0.pdf
282325 PHS_AssignmentRequestForm-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
