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

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Process Development under RG0006:Road Map to a New Seasonal ProcessTry the process for the previous year’sisotypic strain at small scaleWorks?Doesn ’t work?Evaluate at full scale(single cGMP run)Small‐scale development& optimizationWorksDoes not workSmall‐scale validation(limits for pH, etc.)cGMP full‐scale evaluationFinal full‐scaleSeasonal ProcessFrom Clone to Clinic®
Key Changes to H1 DSP Between 2009 & 2010‣ H1 Process modifications were successfully evaluated at small‐scale in PD prior totransfer to manufacturingProcess step H1 2009 H1 2010 RationaleExtraction 0 mM NaCl 50 mM NaCl Improved yieldIEX –wash 2 0 mM NaCl 100 mM NaCl Increased purityIEX ‐ elution 100 mM NaCl 250 mM NaCl Increased step‐yieldHIC ‐ equilibration 0 % CHAPS 0.05% CHAPS Improved purityFrom 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 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 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: RG0006 Governs the Variable Process
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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