Applying quality by design to vaccine development - BioProcess ...

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Identification of New Influenza Virus Strains‣ New ‘A’ viruses arise by recombination or re‐assortment (dual infections) inanimals, birds‣ Most often in the Far East• People living in close proximity to pigs, ducks, etc.‣ Chain of WHO Influenza Diagnostic Laboratories• Constantly checking new isolates for antigenic “Shift” versus “Drift”‣ Requirement for change in vaccine strains when significant drift or a major shiftoccurs, MOST OFTEN IN TYPE A.‣ Notified by WHO in January ‐ March for Western World.‣ CDC, Atlanta GA issues new strains for manufacturers to use‣ These may need additional adaptation to eggs or cell cultureFrom Clone to Clinic®
A Wide Variety of Influenza A Strains ExistH1N1 H1N2H2N2H3N1 H3N2 H3N8H5N1 H5N2 H5N3 H5N8 H5N9H7N1 H7N2 H7N3 H7N7H9N2H9N7•H1N1 was the 1918 “Spanish Flu” type: 20% mortality world‐wide•H1N1 variant was the 2009 Pandemic flu•H2N2 caused the 1957 “Asian Flu”•H3N2 caused 1968 “Hong Kong Flu”•H5N1 is the type associated with “Avian Flu”
Page 1 and 2: Application of Quality byDesign to
Page 4 and 5: ICH QbD Guidance‣ Q8 Pharmaceutic
Page 6 and 7: QbD for Vaccines‣ A‐VAX: Applyi
Page 8 and 9: What Does That Mean?‣ Systematic
Page 10 and 11: QbD Based on Scientific & Risk Base
Page 12 and 13: What are Critical Process Parameter
Page 14: Knowledge SpaceRef: B. Davis, FIP C
Page 17 and 18: Creating a Design Space: Putting it
Page 19 and 20: Design Space: Anion Exchange Column
Page 21 and 22: QbD Work Flow for Development of a
Page 23 and 24: Next Step: Target Product Profile (
Page 25 and 26: Control Strategy Vocabulary 1Termin
Page 27 and 28: QbD for Vaccines27From Clone to Cli
Page 29 and 30: Example:Application of QbD to Influ
Page 31: Diagram of Influenza VirusHemagglut
Page 35 and 36: Recombinant Influenza VaccineIdenti
Page 37 and 38: expresSF+ Engineered for Vaccine Ma
Page 39 and 40: QbD in Influenza Vaccine Case Study
Page 41 and 42: Process Steps have Differing Sensit
Page 43 and 44: PSC SOP RG0006: a Framework for Flu
Page 45 and 46: RG0006 Governs the Variable Process
Page 47 and 48: Key Changes to H1 DSP Between 2009
Page 49 and 50: QbD and Influenza Vaccine-An Existi
Page 51 and 52: Acknowledgements‣ BioProcess Tech
Page 53: Follow us…www.bptc.comwww.bioproc

Applying quality by design to vaccine development - BioProcess ...

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