A review of production technologies for ... - World Health Organization
A review of production technologies for ... - World Health Organization
A review of production technologies for ... - World Health Organization
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Influenza vaccine <strong>production</strong> <strong>technologies</strong> 20 December 2006<br />
Contents<br />
1 Acronyms and abbreviations .................................................................................... 5<br />
2 Preamble...................................................................................................................... 6<br />
3 Influenza vaccines: background ............................................................................... 7<br />
3.1 Seasonal influenza vaccine .......................................................................................... 7<br />
3.1.1 Annual cycle <strong>of</strong> influenza vaccine <strong>production</strong> ...............................................................7<br />
3.1.2 Inactivated influenza vaccines; composition.................................................................8<br />
3.1.3 Live attenuated influenza vaccines...............................................................................8<br />
3.1.4 Novel influenza vaccines ..............................................................................................9<br />
3.2 Pandemic influenza vaccine ......................................................................................... 9<br />
3.2.1 Vaccine <strong>production</strong> capacity.........................................................................................9<br />
4 Review <strong>of</strong> influenza vaccine <strong>production</strong> <strong>technologies</strong>......................................... 11<br />
4.1 Scale........................................................................................................................... 11<br />
4.1.1 Laboratory and pilot-scale manufacture .....................................................................12<br />
4.1.2 Industrial-scale manufacture ......................................................................................12<br />
4.2 Assumptions ............................................................................................................... 12<br />
5 Inactivated influenza vaccines (IIV); egg-based manufacture ............................. 12<br />
5.1 Introduction................................................................................................................. 12<br />
5.2 Laboratory scale ......................................................................................................... 12<br />
5.2.1 Manufacturing process ...............................................................................................12<br />
5.2.2 Resource required......................................................................................................13<br />
5.3 Industrial scale............................................................................................................ 14<br />
5.3.1 Manufacturing process ...............................................................................................14<br />
5.3.2 Resource required......................................................................................................14<br />
5.4 Inactivated influenza vaccine <strong>production</strong> in eggs: summary ...................................... 15<br />
5.4.1 General considerations...............................................................................................15<br />
5.4.2 Advantages <strong>of</strong> egg-based IIV <strong>production</strong>....................................................................15<br />
5.4.3 Disadvantages <strong>of</strong> egg-based IIV <strong>production</strong>...............................................................15<br />
5.4.4 Outstanding questions and issues..............................................................................16<br />
6 Inactivated influenza vaccines: cell-culture-based manufacture ........................ 16<br />
6.1 Introduction................................................................................................................. 16<br />
6.1.1 Cell lines.....................................................................................................................17<br />
6.2 Laboratory-scale......................................................................................................... 17<br />
6.2.1 Manufacturing process ...............................................................................................17<br />
6.2.2 Resource required......................................................................................................18<br />
6.3 Industrial scale............................................................................................................ 18<br />
6.3.1 Manufacturing process ...............................................................................................18<br />
6.3.2 Resource required......................................................................................................18<br />
6.4 Inactivated influenza vaccine <strong>production</strong> in cell culture: summary............................. 18<br />
6.4.1 General considerations...............................................................................................18<br />
6.4.2 Advantages <strong>of</strong> cell-culture-based IIV manufacture .....................................................19<br />
6.4.3 Disadvantages <strong>of</strong> cell-culture-based IIV manufacture ................................................19<br />
6.4.4 Outstanding issues and questions..............................................................................19<br />
7 Live attenuated influenza vaccines; egg-based manufacture ............................. 20<br />
7.1 Introduction................................................................................................................. 20<br />
7.2 Laboratory scale ......................................................................................................... 20<br />
7.2.1 Manufacturing process ...............................................................................................20<br />
7.2.2 Resource required......................................................................................................20<br />
7.3 Industrial scale............................................................................................................ 20<br />
7.3.1 Manufacturing process ...............................................................................................20<br />
7.3.2 Resource required......................................................................................................20<br />
7.4 LAIV <strong>production</strong> in eggs: summary............................................................................. 21<br />
7.4.1 General considerations...............................................................................................21<br />
7.4.2 Advantages ................................................................................................................21<br />
7.4.3 Disadvantages............................................................................................................21<br />
7.4.4 Outstanding issues/questions.....................................................................................22<br />
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