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Pre-Clinical Development Vaccine construct design Upstream process development Formulation Analytical development Potency assay development Product characterization studies Animal immunogenicity Technology transfer to a GMP Contract Manufacturing Organization (CMO) Engineering batches by CMO GMP cell banking Toxicology studies Stability data Clinical Development Dossier submission for Phase 1 IND application Regulatory approval for Phase 1 Phase 1 clinical trial Phase 1, into the clinic The Phase 1 study is usually the first assessment of a vaccine in humans

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