Scaledown Methods

Scaledown methods are critical to assist decision making when the intention is ultimately to operate a purification process at large scale.
This is because when increasing the scale of a purification process from what is typically a laboratory-scale sequence of operations, many changes occur. Some might impact on the cells, such as the change from a benchtop centrifuge to a continuous centrifuge for cell harvest, others may impact on the final product such as the pumping and vialing operation in a large-scale process, all of which can have unpredictable effects that can seriously delay the development of large-scale operations.
Scaledown methods seek to mimic these critical changes to measure the effect (if any) of these changes but to allow this to be achieved with a minimal amount of material, far less than would be required in the pilot plant environment. This provides scope to assess more processing options and the manufacturability of different molecules and host cell lines (as described in the previous section) at realistic scale and hence cost. Methods have been established for operations such as filtration and centrifugation making bench-scale studies which predict full-scale operation feasible. Such methodology has also been developed for chromatography.