Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
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What are Critical Process Parameters (CPPs)‣ Independent process parametersmost likely <strong>to</strong> affect CQAs, including• Purity• Qualitative and quantitativeimpurities• Physical characteristics• Microbial <strong>quality</strong>‣ Determined <strong>by</strong> sound scientificjudgment and based on research,scale‐up or manufacturing experience‣ Controlled and moni<strong>to</strong>red <strong>to</strong> maintainCQAs12From Clone <strong>to</strong> Clinic®