grant
QC and Release Testing of Vector and Cell Clinical Gene Therapy Products
Organization DIVISION OF BASIC SCIENCES - NCILocation UNITED STATES
NIHUS FederalResearch GrantFY2025AllogenicAnnual ReportsAntigen-Presenting CellsAssayAutologousB blood cellsB cellB cellsB-CellsB-LymphocytesB-cellBioassayBiological AssayCRADACell BodyCellsClinicalComplexContracting OpportunitiesContractsCooperative Research and Development AgreementDNA TherapyDataDetectionDevelopmentDisease ProgressionEndotoxinsEnsureEperythrozoonFailureGene Transfer ClinicalGenetic InterventionGood Manufacturing ProcessGood manufacturing practiceHaemobartonellaIndividualInfusionInfusion proceduresLeadManufactured MaterialsMicrobiologyMolecularMycoplasmaOperative ProceduresOperative Surgical ProceduresPatient SchedulesPatientsPb elementPlasmidsProcessProductionQualifyingQuality ControlReagentReportingResearchResidualResidual stateRetroviridaeRetrovirusesSafetySpecific qualifier valueSpecificitySpecifiedSterilitySurgicalSurgical InterventionsSurgical ProcedureTestingTimeTreatment ProtocolsTreatment RegimenTreatment ScheduleViralVirusVirus-RetrovirusWorkaccessory cellcustomized therapycustomized treatmentdevelopmentalendonucleasegene productgene repair therapygene therapygene-based therapygenetic therapygenomic therapyheavy metal Pbheavy metal leadindividualized medicineindividualized patient treatmentindividualized therapeutic strategyindividualized therapyindividualized treatmentinfusionsmanufacturemanufacturing organizationnovelpatient specific therapiespatient specific treatmentpersonalization of treatmentpersonalized medicinepersonalized therapypersonalized treatmentsterilesurgerytailored medical treatmenttailored therapytailored treatmenttimelinetransduction efficiencyunique treatmentvector
Description preview
The release of clinical vector/virus and cell products requires the execution of several concurrent, time sensitive assays by the Surgery Branch Quality Control Unit. These assays demonstrate appropriate conformance to specification metrics of products manufactured both at the Surgery Branch and from external labs such as Contract Manufacturing…
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