(762d) Predicting Buffer and Media Preparation Times for Single-Use Mixer Scale-Up

As the implementation of single-use mixing technologies in biopharmaceutical manufacturing operations expands, scaling and mix time predictability has been a focus for characterization and improvement. For a series of commercially available single-use mixers, operating conditions consisting of solution volume, mixer power, and mixer speed were identified using a mixer scaling and predictability parameter, which produced a similar mixing time for a given solution across different scales of mixer.  As exhibited in this study, this methodology was used to develop a protocol for the time predictable preparation of several buffers and cell culture media at volumes ranging from 10 to 1000 L. The development of this protocol will facilitate scale-up and scale-down during process development and process simulation efforts while reducing resource consumption. Moreover, the 50 L system demonstrated to be a reliable scale-down device for the development of time predictive mixing operations that could be scaled and implemented in the 1000 L system.