(435d) Centrifugation at Scale: Scaling up Based on Bench Top, Pilot Plant and Modeling Data

Selecting the recommended centrifugation parameters for full scale manufacturing before the first site run is key to a successful technical transfer. Centrifugation scale-up poses unique challenges due to the differences in centrifuge geometry, rotational speed, and automation levels at different manufacturing sites and lab set-ups. Using a combined approach modeling, lab experiments, and pilot plant data, starting parameters for manufacturing could be selected for loading rate, loading spin speed, and final speed. The recommended starting values were then used to shape the optimization at full scale.