Scale Up and Facility Fit
Last-minute changes? No problem!
Mechanistic modeling claims to be generally valid beyond the space spanned by the calibration experiments. It is safe to assume that the basic assumptions hold at least for a fixed combination of chromatography resin, buffer system and feed components.
For example, if a process was developed that involves a gradient elution but the designated facility only allows step elutions, no additional lab work is required. A mechanistic model used for gradient optimization can just as well be used to develop a step elution.
The same applies when a change in pooling decisions becomes necessary in case hold tank volumes change. With in silico process development, the implications of changes in feed volume and concentration or the whole fractionation strategy can be quickly evaluated.