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

More documents

Recommendations

Info

Baculovirus Expression of Influenza Antigens• Influenza antigens can be expressed by cloning into Baculoviruses and growing ininsect cell culture– Baculovirus has limited host range (No infection of mammalian cells)– Rapid scale‐up and production of new vaccine strains possibleIsolate Target GeneCreate RecombinantBaculovirus StrainGrow Up a Batch ofInsect CellsInfect & IncubateHarvestInfected CultureClarify HarvestOrNovavax: Purify VLPCollect CellsProtein Sciences: Extract & Purify rHAFrom Clone to Clinic®
expresSF+ Engineered for Vaccine Manufacturing‣ Cell line developed from Sf9 Cells• Selective pressure in serum‐free media withadded insulin (0.4 mM)• unique phenotypic and genotypic properties‣ Protein Sciences (Meriden, CT, USA) has developed FluBlok®using their proprietary BEVS baculovirus expression system• Contains three recombinant HA antigens― Dose of each antigen is 3X egg‐produced dose• Over 50,000 doses delivered with minimal adverseevents― Highly effective protective immunity generated• BLA filed, awaiting approvalUninfected SF+Infected SF+From 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: Recombinant Influenza VaccineIdenti
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 ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?