OpportunityTitle: Development of advanced analytical methods for the characterization of complex generics
AdditionalInformationOnEligibility: Section III. Eligibility Information1. Eligible ApplicantsEligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe 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 Institutionso   Historically Black Colleges and Universities (HBCUs)o   Tribally Controlled Colleges and Universities (TCCUs)o   Alaska Native and Native Hawaiian Serving Institutionso   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-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.
Description: 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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592