1. Discuss the implications of Quality by Design (QbD) in bioprocessing for regulatory compliance and process robustness. How do risk assessment and design of experiments (DoE) play a role in ensuring product quality ?

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Step 1 Quality by Design QbD and process robustness are two key concepts in the field of bioprocessing particularly in pharmaceutical and biopharmaceutical manufacturing Lets define and explain each 1 ... View the full answer