The Food and Drug Administration is seeking applications for its Development of Advanced Analytical Methods to develop a sensitive and practical method/approach to analyze the diastereomer composition in a PS oligonucleotide (e.g., inotersen or nusinersen), and evaluate how different activator/conditions of coupling affect the stereochemical outcome of the PS linkages.
Donor Name: U.S. Food and Drug Administration (FDA)
State: All States
County: All Counties
Type of Grant: Grant
Deadline (mm/dd/yyyy): 03/07/2022
Grants Size: $300,000
Grant Duration: 2 years
Details:
Advanced analytical methods for characterization and comparative analysis of complex products, which help to link product attributes to product quality, safety and efficacy, are useful for facilitating the development of generic complex products. The purpose of this study is to develop advanced analytical methods for analyzing the diastereomer compositions in phosphorothioate (PS) oligonucleotides using either TEGSEDI (inotersen) or SPINRAZA (Nusinersen) as the model product. The proposed studies will focus on 1) understanding the diastereomer composition in TEGSEDI or SPINRAZA (Nusinersen), and 2) determining whether and how the manufacturing process may affect the diastereomeric distributions in the drug product. Methods developed through this research may also be applied in cases of other synthetic oligonucleotides, and could greatly facilitate the development and assessment of generic oligonucleotide drug products. Knowledge gained from this research may also contribute to quality control of oligonucleotide drugs.
Specifically, this project should include:
- The development and validation of a sensitive, reproducible method/approach to analyze the diastereomer composition of TEGSEDI (inotersen) or SPINRAZA (nusinersen).
- The assessment of potential batch-to-batch variability for diastereomer composition of TEGSEDI or SPINRAZA.
- Investigation of the effect of activators/coupling conditions on the stereochemical outcome in PS linkage formation in the synthesis of inotersen or nusinersen including shorter-length intermediates.
- Comparative studies on diastereomer composition of the in-house prepared inotersen vs TEGSEDI (inotersen) or in-house prepared nusinersen vs SPINRAZA (nusinersen).
Funding Information
- FDA/CDER intends to commit $300,000 in FY 2022 to fund up to one (1) award.
- The maximum project period is two (2) years
Eligibility Criteria
- State governments
- County governments
- City or township governments
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- For profit organizations other than small businesses
- Public and State controlled institutions of higher education
- Independent school districts
- Small businesses
- Special district governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- 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:o Hispanic-serving Institution so Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institution so 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 Non-domestic (non-U.S.) Entities (Foreign Institutions)Foreign Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
For more information, visit Grants.gov.