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

PSC SOP RG0006: a Framework for FluBlok ®Seasonal Strain-change Development‣ Applied to the process development for each new FluBlok component strain‣ Developed with FDA guidance to define acceptable modifications in downstreamprocess parameters within the scope of a validated process.‣ Assures FDA that:• any process changes are necessary and minimal.• process performance remains consistent season to season‣ Provides PSC Process Development group with guidance so that:• development procedures and acceptance criteria are clearly defined.• PD can work rapidly, knowing that process changes within RG0006 do notrequire regulatory modification.‣ Process changes outside of RG0006 require regulatory modification (ChangeControl)SOP RG0006 guides the work flow anddefines the downstream process design spaceFrom Clone to Clinic®