Fill and finish processes for biologics include a critical mixing step to reduce non-uniformities in fluids and to eliminate concentration and pH gradients formed during freezing. Proper mixing is essential to prevent protein degradation due to mechanical stress.

This study characterized fluid dynamics and mixing behavior in disposable square-cross-section vessels like Cytiva’s Levmixer. It focused on a 200L commercial vessel and a custom-designed 1L vessel. Key factors such as stirrer speed, fill volume, viscosity, impeller size, and impeller placement were analyzed to assess their impact on product quality using protein solutions as surrogates.

JMP was used to design experiments and generate a predictive model for small-scale mixing. In parallel, computational fluid dynamics (CFD) simulations provided insights into fluid flow and mixing in the larger vessel. The comparison of JMP’s model with CFD simulations showed a strong correlation, with consistent predictions for mixing times and conditions across both scales.

This complementary approach reduced development time and costs while ensuring product quality during scale-up from 1L to 200L, highlighting the value of combining JMP with CFD for scalable process optimization.