Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 6

The amount of subvisible particles, including protein aggregates, in the humanized anti IFNɤ and both reengineered variants was characterized using Micro-Flow Imaging (MFI). V#1 and V#2 variants display a 5- to 10-fold reduction in the number of particles below 3.5 μm compared to the humanized anti IFNɤ. Both reengineered variants contain no detectable particles over 3.5 μm.