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

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Design Space‣ Design space is proposed by the applicant and is subject to regulatory assessmentand approval• Any process that runs within previously defined and approved design space isnot considered a change• Operation outside of previously approved design space requires a regulatorypost‐approval change processRepeat UnitsYieldRM 1RM1From Clone to Clinic®
Creating a Design Space: Putting it All Together‣ Summarize results ofmultiple experiments todefine response surface‣ Validate the process todemonstrate consistentproduction of productwith desiredcharacteristics% LysisFeed RateDesign SpaceRaw Material 1RepeateUnitsFrom Clone to Clinic®
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 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 and 32: Diagram of Influenza VirusHemagglut
Page 33 and 34: A Wide Variety of Influenza A Strai
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

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