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

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Protein Sciences FluBlok ® ExpressionBaculovirus Expression Vector System (BEVS)• Engineer baculovirus with thegene of interest (e.g.Hemagglutinin)• Baculoviruses highly specific toinsect cells• Powerful promoter generateshigh yield of protein of interest• Culture expression ofinsect cells in afermenter• Infect cells withengineered virus• Incubate infection for ~48 ‐72 hours• Protein forms rosettes• Purify protein to > 90%into final product• Formulate with PBS intovaccineFrom Clone to Clinic®
QbD in Influenza Vaccine Case Study: Flublok ®‣ Flublok must be changed each year to produce the current strains• In 2011 the strains were the same for US as in 2010• Impact of strain changes on antigen biochemistry can be conservative orsignificant—Driven by epidemiology• Process must cope with annual potential change of input antigen whileoperating within predefined design space—SOP in place at Protein Sciences to drive process adaptation to newstrains
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: expresSF+ Engineered for Vaccine Ma
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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