Validation could also be provided in the characterisation of excipient eects on protein stability, by monitoring changes in aggregate size, protein secondary and tertiary structure and biological activity assays. However, the stability of HSA and its own use as an antiaggregation agent 90 would make reliably inducing (and measurably arresting or preventing) aggregation challenging. This points to a need for a protein-independent model, which would be most easily developed by modelling one or more dierent therapeutically relevant proteins, ideally with their own stability issues, such as insulin or the binding fragment of an antibody. Additionally, validation of the PLS model can be increased by the introduction of more simulation data, which can either be included in the predictive model or excluded from it and used as a validation test set.