Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
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QbD Work Flow for Development of a VaccinePotential CQAsInterim CQAsFinal CQAControl StrategyPlatform KnowledgeTox Study RangesNon‐clinical studiesDose rangingProcessValidationFew Tests andNarrow AcceptanceRangesMultiple Tests withWide Acceptance RangesBLA SubmissionPhase 1 Phase 2 Phase 3 Commercial21 From Clone <strong>to</strong> Clinic®