Demonstrating robustness of manufacturing processes has become a regulatory expectation, and is commonly achieved through an understanding of the relationship between critical process parameters and their effect on process performance and product critical quality attributes.  Since performing studies to show understanding of these relationships at the manufacturing scale are not always feasible due to high costs of operation and availability of bioreactors, it is crucial to develop a scale-down bioreactor model to accurately predict process performance and product quality at manufacturing scale.  In this study, we developed a bioreactor scale-down model to characterize a cell culture process for monoclonal antibody production in NS0 cells.  The scale down model uses 5-L scale bioreactors to mimic the 1000-L bioreactor manufacturing process.  Profiles of cell growth, productivity, culture environment and level of metabolites, along with product quality attributes were compared between the two scales to qualify the scale-down model.

Development of a bioreactor scale- down model for a monoclonal antibody perfusion process

245th National Meeting (2013)

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