(593a) The Use of Mobius Mix Vessels with Protein Solutions: Impact of Impeller Flow and Particle Shedding on Protein Turbidity and Aggregation

The increasing implementation of single-use equipment and assemblies in biopharm processes has resulted in more flexible facilities with faster batch-to-batch and product-to-product turnaround times. However, it has also resulted in new questions about how the materials of construction and system functionality might impact the drug products being produced.  Customers considering a move to single-use mixing systems for buffer preparation have typically wanted information about particulate count and generation and extractables/leachables identity and levels as well as guidance on an effective mix protocol to ensure robust dissolution of buffer components. But when considering these same mixing systems for protein pools, additional concerns are raised about the potential impact of the impeller action and the particulates on protein quality and stability. To have a better understanding of the use of the Mobius MIX family for protein pools, we performed a study to determine whether we could detect a change in protein quality during mixing and whether the change could be correlated to a mixing parameter. In addition, we evaluated whether the particulates that are generated have an impact on short-term protein stability.