A legacy Genentech process was updated to increase manufacturing flexibility, ensure product supply, and improve operator safety.  Cell culture productivity was increased 2-fold and the purification process was revamped to improve plant fit, remove a prominent product variant and increase throughput.  Only the cell bank and drug product formulation / configurations were maintained.  Several example technical challenges during development and implementation will be discussed.  The final process utilizes an entirely different purification process flow, but analytical comparability was successfully achieved.

Overcoming technical challenges while updating a legacy commercial production process

243rd National Meeting (2012)

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