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Influenza Vaccine Manufacturing

Influenza Vaccine Manufacturing. Critical Components Egg Supply Seed Virus High growth reassortants Potency test reagents. January 30, 2002. Weeks. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 1. 2. 3.

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Influenza Vaccine Manufacturing

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  1. Influenza Vaccine Manufacturing • Critical Components • Egg Supply • Seed Virus • High growth reassortants • Potency test reagents January 30, 2002

  2. Weeks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Prepare high growth reassortant seed Prepare working seed Prepare monovalent concentrate Test monovalent Pool monovalent concentrate Test concentrate pool CBER Release Prepare bulk vaccine Test bulk vaccine CBER Release Filling Test final container Prepare purified HA Prepare reference antiserum Prepare reference antigen Standardize reagents CBER Manufacturing Testing Influenza Vaccine ManufacturingFirst dose, one strain change January 30, 2002

  3. Jan. . . .Oct. Nov. Dec. Jan. Feb. Mar. Apr. May June July Aug. Sept. Oct. Nov. Dec. ­ ­ Order House birds birds Receive candidate seed viruses Prepare high - growth reassortants ­ ­ ­ Start Start Start st nd rd 1 2 3 strain strain strain Monovalent concentrate production Potency test reagent preparation Vaccine formulation Vaccine filling ­ ­ ­ CBER Strain License Selection Issued Vaccine Distributed CBER/CDC Manufacturing and Distribution January 30, 2002 Influenza Vaccine Manufacturing Timeline

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