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VRBPAC 25 February 2011

Influenza Vaccine Manufacturing Critical Factors

Objective:  Distribution & Administration of influenza vaccines prior to peak season

Global timing of strain selection

Ensures timely availability of very large quantities of vaccines while manufacturers accept some risk by starting production early

Requires consideration of strain surveillance, selection timing, and impact to vaccine availability

Allows final development of working seeds that require a minimum of 4 weeks from receipt of a viable candidate virus through release prior to use in large-scale manufacturing

Minimizes impact of constraints imposed by the least productive monovalent strain candidate

Availability of Potency Test Reagents

Lengthy process of preparation and standardization

Linked to global timing of strain selection for new strains

Constrains start of formulation of finished vaccine

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