New Paradigm of Building Quality during Manufacture - Challenges with Biologics

Presented by

Dr Rajesh K. Gupta

About this talk

Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implementation of Good Manufacturing Practice (GMP) regulations with current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.

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