grant

Process development for manufacturing eCD4-Ig

Organization EMMUNE, INCLocation Juno Beach, UNITED STATESPosted 1 Jan 2023Deadline 31 Aug 2028
NIHUS FederalResearch GrantFY2025AIDS VirusAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAffinity ChromatographyAnionsAntibodiesApplications GrantsAssayBindingBioassayBiologicalBiological AssayBuffersCell BodyCell LineCellLineCellsChromatographyCirculationClinicClinical Treatment MoabCustomDNA mutationDevelopmentDrugsELISAEarly-Stage Clinical TrialsEnzyme-Linked Immunosorbent AssayExclusionFcRnFcRn neonatal transfer proteinFormulationFundingGenetic ChangeGenetic defectGenetic mutationGlycoengineeringGrantGrant ProposalsHIVHIV Envelope Glycoprotein gp120HIV Envelope Protein gp120HIV InfectionsHIV ReceptorsHIV env Protein gp120HTLV-III InfectionsHTLV-III ReceptorsHTLV-III gp120HTLV-III-LAV InfectionsHalf-LifeHuman Immunodeficiency VirusesHuman T-Lymphotropic Virus Type III InfectionsHydrophobic InteractionsImmunochemical ImmunologicImmunologicImmunologicalImmunologicallyImmunologicsInjectableIntravenousLAV-HTLV-IIILength of LifeLife ExtensionLongevityLymphadenopathy-Associated VirusMarketingMass Photometry/Spectrum AnalysisMass SpectrometryMass SpectroscopyMass SpectrumMass Spectrum AnalysesMass Spectrum AnalysisMeasuresMedicationMolecular InteractionMonoclonal AntibodiesMutationOralOutsourcingPatientsPerfusionPharmaceutical PreparationsPhasePhase 1 Clinical TrialsPhase I Clinical TrialsProcessProductionProteinsProteolytic ClippingProteolytic ProcessingReceptor ProteinRegimenResistanceSIVSimian Immunodeficiency VirusesSiteStrains Cell LinesSubcutaneous InjectionsSulfateSynthetic antigen binderTechnology TransferTemperatureTherapeuticTimeValidationVirus-HIVViscosityWorkaffinity purificationanalytical methodantibody mimeticsantibody-like binderantibody-like moleculeantibody-like proteinantibody-like reagentbiologiccultured cell linecustomsdevelopmentaldrug/agentenzyme linked immunoassayfabrication technologygenome mutationgp120gp120 ENV Glycoproteingp120(HIV)improvedintravenous administrationintravenous injectionmAbsmanufacturemanufacturing process developmentmanufacturing qualitymanufacturing technologymimeticsmonoclonal Absnative protein drugneonatal Fc receptorpharmaceutical proteinphase I protocolpillpreventpreventingprocess optimizationprotein drug agentprotein-based drugreceptorresistantsialylationsmall moleculesmall molecule therapeuticssubcutaneoussubdermalsubdermal injectionsulfotyrosinesynthetic antigen binding reagenttherapeutic proteintyrosine O-sulfatetyrosine sulfatevalidations
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Description preview

ABSTRACT
eCD4-Ig is an antibody-like therapeutic for HIV that was constructed by fusing CD4 domains 1 and 2, and

an HIV coreceptor-mimetic sulfopeptide, to the N- and C-termini of the constant Fc region of an antibody.

eCD4-Ig will join an emerging class of long-acting therapeutics for treating and preventing HIV infection. As

a consequence of…

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Process development for manufacturing eCD4-Ig — EMMUNE, INC | UNITED STATES | Jan 2023 | Dev Procure