Characterizing and measuring the ice nucleation kinetics of aqueous solutions in vials

The stochastic nature of ice nucleation presents a major challenge in freezing and freeze-drying processes biopharmaceuticals vials. During freezing, events occur the vials batch at different times temperature, which has to be accounted for process design. This work paves way towards model-based design, by presenting method estimate kinetic parameters their uncertainty from experimental data generated parallelized mid-throughput batch-crystallizer. methodology extends conventional description considering both inherent stochasticity, variability heterogeneous sites among Model validation revealed nearly quantitative agreement predictions extended model with data, qualitative one model. While this focuses on kinetics, rigorous analysis may also relevance studies related fields, such as industrial crystallization.