Technical Summary

Freeze-thaw is a critical process in biologics manufacturing, used to preserve and stabilise products by reducing chemical and biological degradation and limiting external contamination, thus extending product shelf-life and integrity. However, the process presents challenges such as cryoconcentration of solutes, alterations in the physicochemical properties of formulations, scale-up inefficiencies due to thermal transfer limitations, and limited process monitoring and control. These factors can significantly compromise product quality and reliability. To meet the high standards of the biopharmaceutical industry, robust process design and control strategies are essential.

Aris Melloni’s research addresses these challenges by developing a lab-scale freeze-thaw system integrated with real-time monitoring and process analytical technologies (PAT), supported by predictive computational models aimed at improving process control and product stability. His work also investigates container design and formulation strategies to enhance heat transfer efficiency and mitigate degradation effects during freezing and thawing.  Through this multidisciplinary approach, combining experimental system development, modelling, and material science, the research aims to optimise freeze-thaw performance by advancing process understanding, enabling more precise control, and improving design, scalability and reliability.