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 alumes, 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.

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