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- W3092068035 abstract "Biopharmaceuticals are often lyophilized to improve their storage stability. Controlling ice nucleation during the freezing step of the lyophilization process is desired to increase homogeneity of product properties across a drug product batch and shorten the primary drying time. The present communication summarizes the process optimization of the freezing process when using vacuum-induced surface freezing to control ice nucleation, in particular for amorphous samples. We characterized freeze-dried samples for solid state properties, and compared these to uncontrolled nucleated samples using bovine serum albumin (BSA) as a model protein. Freezing parameters were optimized to obtain complete nucleation, adequate cake resistance during the subsequent lyophilization cycle, and elegant cakes. We highlight the challenges associated with vacuum-induced surface freezing and propose optimized freezing parameters to control ice nucleation, enabling manufacturing of amorphous samples." @default.
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- W3092068035 date "2020-10-08" @default.
- W3092068035 modified "2023-09-27" @default.
- W3092068035 title "Controlling Ice Nucleation during Lyophilization: Process Optimization of Vacuum-Induced Surface Freezing" @default.
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- W3092068035 doi "https://doi.org/10.3390/pr8101263" @default.
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