grant

DEVELOP, QUALIFY IMMUNOLOGICAL ASSAYS, AND PROVIDE CLINICAL SAMPLE TESTING FOR AAV-BASED GENE THERAPY CLINICAL CANDIDATES

Organization LEIDOS BIOMEDICAL RESEARCH, INC.Location FREDERICK, UNITED STATESPosted 15 Sept 2025Deadline 14 Sept 2030
NIHUS FederalResearch GrantFY2025AntibodiesAssayBioassayBiological AssayCLIA accreditedCLIA approvedCLIA certifiedCLIA compliantCLIA licensedCapsid ProteinsCellular AssayClinicalClinical EvaluationClinical ProtocolsClinical TestingClinical TrialsCoat ProteinsContractorDNA TherapyDataData ReportingDocumentationDrugsEligibilityEligibility DeterminationGene Transfer ClinicalGenetic InterventionImmunology procedureInfusionInfusion proceduresLaboratoriesMedicationMethodsNCATSNational Center for Advancing Translational SciencesNeutralization TestsNeutralizing antibody assayPatientsPharmaceutical PreparationsProtocolProtocol ScreeningProtocols documentationQualifyingReagentReportingResearch SubjectsSamplingSampling StudiesShippingT cell responseT-CellsT-LymphocyteTest ResultTestingTransmissionViral Coat ProteinsViral Outer Coat ProteinWritingantibody assayantibody based testantibody neutralization testantibody testassay developmentcell assayclinical candidateclinical testdata representationdata representationsdrug/agentgene repair therapygene therapygene-based therapygenetic therapygenomic therapyimmunogenicityimmunologic assayimmunologic assay/testinfusionsinterestlaboratory manualsneutralizing antibodyneutralizing antibody testresearch clinical testingthymus derived lymphocytetransmission process
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Description preview

The contractor shall develop OR adapt/use previously developed (if available): anti-drug antibody
(ADA) and neutralizing antibody (NAb) assays as well as T-cell immunogenicity assays to support
NACTS clinical trials including the MMA-101 gene therapy candidate and implement the assays
for testing of clinical samples for the FIH clinical trial of…

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DEVELOP, QUALIFY IMMUNOLOGICAL ASSAYS, AND PROVIDE CLINICAL SAMPLE TESTING FOR AAV-BASED GENE THERAPY CLINICAL CANDIDATE | Dev Procure