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

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Process Development Under SOP RG0006‣ What does RG0006 tell the Protein Sciences Process Development group?• Organizes work flow between small‐scale and large‐scale.• Specifies scale‐down models.• Specifies conditions which may be altered.• Defines acceptance criteria for each step• Provides a small‐scale validation of process performance prior to transfer.• Specifies reporting activities for process transfer.From Clone to Clinic®
RG0006 Governs the Variable Processing StepsupstreamdownstreamProcessstepIsotypevariability(H1, H3, B)SeasonalstrainvariabilityVariableparametersModifiableunder RG0006?fermentation universal noharvest universal noextraction yes infrequent pH; [detergent] yesclarification yes noIEX yes oftenHIC yes someDepth filtertypepH; [salt];column type;[detergent]pH; [salt];[detergent]noyesyesQ membrane universal noTFF universal noOnly process steps with seasonal variabilityare modifiable under RG0006From 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: PSC SOP RG0006: a Framework for Flu
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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