While the drivers for this process modernization included improved robustness, reduction in cycle time and reduction in cost of goods, modernizing a commercially-approved process for a legacy product carries the potential for risk, challenges and complexity throughout development, implementation and validation.  The modernization of the downstream purification process for a monoclonal antibody product involved implementing dead-end virus filtration in place of tangential flow virus filtration, modifying a process stage and relocating the virus filtration step in the process.  The successful development, scale-up, implementation and validation of these modifications to the downstream purification process will be discussed.

Modernization of the downstream purification process for a commercially-approved monoclonal antibody product

243rd National Meeting (2012)

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