Formulation Services

Measuring and modelling mAb aggregation

Smartfreez can use the Cold Stability Accelerator to measure protein cold-aggregation, under accelerated conditions (by approaching cold denaturation temperature). These measurements complement elevated temperature data (e.g. customer’s data) to anticipate cold stability in a few days/weeks and develop accurate degradation models, to predict long term stability (months/years).

Freeze-thaw studies in representative conditions

Smartfreez performs freeze-thaw studies in small volumes, a physical down-scale model of customers manufacturing processes. The time within ice while above glass transition correlates directly with protein degradation. The distribution of this stress-time across a container can be obtained by CFD simulation, and imposed in a 5 mL vial using the Micro Scale Down.