Avoid Unmixed Process Solutions Design and Execution of Solution Mixing Studies for Biopharmaceutical Production
When it comes to mixing studies, what is an effective strategy and what factors should be analyzed?
Efficient mixing of processing solutions is critical to ensure process consistency and comparability. Although biopharmaceutical processes may use a large number of process solutions and vessel configurations (1–3), mixing validation is typically not undertaken at production scale for every solution. Instead, a risk assessment may be completed to identify the risks or impacts associated with the factors needed to dissolve chemicals used for solution preparation (4). The results of this assessment are then used to identify which representative buffer solutions require validated mixing studies. This process offers a high degree of confidence that all solutions used will be homogenous and appropriately mixed.