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

What Does That Mean?‣ Systematic approach to development• Identify the customer• Use tools to prioritize activities• Iterative process building on knowledge gained‣ Predefined objectives• CQAs• QTPPs‣ Emphasizes product and process understanding and process control• Identification of critical process parameters linked to CQAs• Prior knowledge‣ Based on sound science• First principles understanding‣ Quality risk management• Use risk assessment tools consistently• Revise risk assessments as knowledge is gained8 From Clone to Clinic®