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

QbD and Influenza Vaccine-An Existing Paradigm‣ Influenza vaccines have always been manufactured within a design space• Annual strain changes impact egg production as much as recombinantproduction‣ Provides an operational case study for FDA review and implementation to otherproduct classes‣ Enables regulatory flexibility and adaptation to emergency or rapid responserequirements‣ Quality by design as a regulatory shift will, in the long run, facilitate manufacturingdecisions and product approvals for vaccines and other productsFrom Clone to Clinic®