The use of scale-down models for bioprocess unit operations is critical for any program that aims to rapidly meet the challenges of commercialization.  Scale-down models are commonly used for process development, process characterization and lab-scale troubleshooting of large-scale commercial processes.  With line of sight to manufacturing facilities and equipment, a scale-down model checklist was developed that allowed the identification of scale-dependent and scale-independent parameters along with gaps to the commercial process.  We will present a case study in which a 3-L bioreactor was established as a scale-down model to the 5000-L manufacturing scale for a therapeutic monoclonal antibody process.  Our methodology toward scale-down qualification of the 3-L bioreactor and its use as a predictive and directional indicator of manufacturing scale will be discussed.  The success of this model will be assessed by the analysis of process outputs, such as peak cell density, metabolic profile, product titer and quality.

Scale-down model qualification methodology for a monoclonal antibody program

243rd National Meeting (2012)

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