Predicting Buffer and Media Preparation Times for Single-Use Mixer Scale-Up

Pharmaceutical Discovery, Development and Manufacturing Forum
AIChE Annual Meeting
November 7, 2013 - 4:30pm-5:00pm

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.

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