Regulatory requirements for demonstrating product comparability for a Post-commercial Manufacturing change are often quite intensive, in particular for therapeutic proteins.  In this talk, I will present a case study from the approach taken during the development and implementation of a nanofiltration unit operation in a plasma-derived, very large therapeutic protein manufacturing process.  Using QbD principles such as prior knowledge, risk assessment, and design-of-experiments, process design space was developed.  Comparability of process and product at bench, pilot and manufacturing scales was also demonstrated.

Post-commercial manufacturing change using QbD principles: Development and implementation of a nanofiltration step in a therapeutic protein process

243rd National Meeting (2012)

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