Ice Crystal Analysis in the Freeze-Drying Process ～Optimizing Manufacturing Processes with AI～

Challenge

In the freeze-drying (lyophilization) process commonly used for biologics, annealing—a step in which the temperature is briefly raised after initial freezing and then lowered again to complete solidification—plays a crucial role. This process promotes and homogenizes ice crystal growth, contributing to the production of formulations with superior appearance, high transport stability, and uniform quality. To optimize ice crystal growth, microscopic observation of ice crystal formation during annealing is essential. However, manually observing all crystals throughout the process is time-consuming and prone to variability between evaluators. Moreover, it is difficult to accurately separate overlapping ice crystals and to quantitatively evaluate the number and area of crystals over time.

LPIXEL’s Solution – AI Technology and Impact

LPIXEL’s AI image analysis technology makes it possible to detect and separate overlapping ice crystals and quantify the number and area of individual ice crystals. This advancement automates the analysis of the ice crystal growth process, achieving a significant reduction in analysis time and is expected to be instrumental in optimizing the manufacturing processes for complex therapeutics, such as ADCs (Antibody-Drug Conjugates) and antibody-based pharmaceuticals.