469808 Product-Agnostic Computational Fluid Dynamic (CFD) Model for Single-Use Mixing System

Monday, November 14, 2016: 2:50 PM
Continental 5 (Hilton San Francisco Union Square)
Ahsan Munir1, Sean Fitzgibbon2, Kenroy Noicely2, Alan Dominguez2, Adam Sokolnicki3 and Cenk Undey2, (1)Amgen, Cambridge, MA, (2)Amgen, Thousand Oaks, CA, (3)Biomanufacturing Sciences Network, EMD Millipore Corp., Billerica, MA

As the interest in single-use systems continues to grow in the biopharmaceutical community, mixing is a phenomenon that needs to be understood and characterized routinely, taking effort and time. Insufficient mixing can lead to content inhomogeneity, while excessive mixing can lead to protein denaturation as well as an increase in cycle time. To help reduce experimentation for future process transfer and scale-up, a product-agnostic multiphase computational fluid dynamic (CFD) model was developed. The CFD model establishes a process design space for 10L and 50L single-use mixing bags. The design space can be used by product teams to define impeller speeds in order to achieve the desired blend times based on working volumes of fluid, and fluid properties. These studies will accelerate the design and use of single-use stirred bags to formulate drug solutions.

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