A review of production technologies for ... - World Health Organization

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Influenza vaccine production technologies Figure 2. Comparative times for producing a batch of pandemic influenza vaccine Week 1 - 6 7 8 9 10 11 12 IIV Eggs IIV Cells LAIV Eggs Production of vaccine strain 1 Inoculation and culture Inoculation and culture Inoculation culture and harvest Harvest, split & purify Harvest, split & purify Sterility testing Release Sterility testing 2 Sterility testing 2 Release 3 Release 3 Notes and assumptions 1 – Production of vaccine seed on LAIV background strain is not routinely undertaken at present. This would have to be established at WHO collaborating centres 2 – Additional QC testing will be required in addition to sterility testing. However sterility testing would be the rate-limiting step determining release date (but see note 3). 3 – Assuming release of IIV is possible on protein quantification data only. Reagents to quantify HA content may not be available until weeks 16 – 20. Page 32 of 34
Influenza vaccine production technologies Figure 3. Comparative timeline and cost required to establish large-scale seasonal influenza vaccine production capacity Investment required (US$ millions) 1000 100 10 1 0 LAIV CEF IIV Egg LAIV Egg IIV Egg IIV, TC Established line IIV, TC New cell line Time 2 required to establish 4 season6 al vaccine pro8 duction (year10 s) Dark shading – adapt or scale-up the process in an existing facility using the same methodology Light shading – set up process from scratch on an existing vaccine campus Area of circle represents relative scale of production Page 33 of 34 12
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A review of production technologies for ... - World Health Organization

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