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

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QbD for Vaccines‣ A‐VAX: Applying Quality by Design to Vaccines‣ http://www.pda.org/Home‐Page‐Content/CMC‐VWG‐A‐VAX.aspx‣ Produced by the CMC‐Vaccines Working Group• GSK, MedImmune, Merck, Pfizer, sanofi pasteur‣ Placed in the public domain by PDA‣ Use the A‐Vax study product and process description for general discussion ofQbD approach for development of vaccines6 From Clone to Clinic®
What is QbD?‣ Quality by Design (QbD) is a concept first outlined by well‐known quality expertJoseph M. Juran in various publications, most notably Juran on Quality by Design.Juran believed that quality could be planned, and that most quality crises andproblems relate to the way in which quality was planned in the first place.‣ QbD identifies characteristics that are critical to quality from the perspective ofpatients, translates them into the attributes that the drug product should possess,and establishes how the critical process parameters can be varied to consistentlyproduce a drug product with the desired characteristics.‣ Systematic process to build quality into a product from the inception to finaloutput.‣ Quality by Design is a systematic approach to development that begins withpredefined objectives and emphasizes product and process understanding andprocess control, based on sound science and quality risk management.7 From Clone to Clinic®
Page 1 and 2: Application of Quality byDesign to
Page 4 and 5: ICH QbD Guidance‣ Q8 Pharmaceutic
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 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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