(487b) CFD Simulation on Assessment of Biologic Product Mixing Performance in Single Use Technology

The biopharmaceutical industry and has undertaken radical change in the design and operation of many bioprocess. These changes provide more robust process and increased production flexibility. The benefits of Single Use Technology (SUT) for equipment train flexibility and reduced cleaning logistics are now widely acknowledged. This trend has resulted in rapid growth of SUT(equipment) manufactures and product offerings.

 In order to select the right SUT from multiple vendors for protein drug product mixing operation, a CFD simulation was applied to assess the impact of the size and shape of tank and impeller,, fill level, and agitation rate on the flow and mixing behavior. An approach was developed by introducing two concepts: the highest accumulated shear rate and mixing time safety factor. These parameters, respectively, quantify the acceptable boundaries of shear and mixing time validated within the operational ranges established for a commercial product based on product specific stability profile.

The model simulations were used to assess the SUTs mixing performance, the mixing time, highest accumulated shear rate, and range of acceptable agitation rate for three different SUTâ??s vendors. Compared with the existing mixing operation for the commercial product, the mixing performance was classified and the decision was made to select the optimal SUT for the product being considered.