A risk ranking and filtering assessment was utilized to evaluate the effects of varying Ultrafiltration/Diafiltration (UFDF) parameters on product quality and manufacturing performance of a high-concentration monoclonal antibody product formulation. A risk- and science-based approach was utilized to identify UFDF process parameters and membrane regeneration conditions to include in process characterization and validation studies. The risk scores were generated and used to plan meaningful experiments to establish acceptable operating ranges, while minimizing the number of experiments and mass requirements to conduct the studies. This effort supports the identification of a UFDF design space and critical process parameters.

Ultrafiltration diafiltration: Process characterization and process validation

251st National Meeting (2016)

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