Abstract
Freezing is an essential step in pharmaceutical manufacturing processes for a long-term storage of therapeutic proteins. However, the process itself may affect the stability of proteins. Better understanding and quantification of freezing dynamics and the local environment from liquid solution to the frozen state would help to mitigate negative impacts on the protein products during freezing and subsequent manufacturing processes. We present a phase-field approach to resolve the relevant macroscopic transport phenomena including multi-phase flow, heat transfer, phase transition, and freeze concentration effects coupled with interfacial evolution in a cylindrical vessel. The theoretical formulation and modeling results show good agreement with experimental data.
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