Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse.

@article{Overcashier1999LyophilizationOP,
  title={Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse.},
  author={David E. Overcashier and Thomas W. Patapoff and Chung Chan Hsu},
  journal={Journal of pharmaceutical sciences},
  year={1999},
  volume={88 7},
  pages={688-95}
}
During the lyophilization process, formulations containing protein, bulking agent, or lyoprotectant form a dry product layer that can affect the transport of sublimed water vapor. We carried out an investigation of the primary drying segment of lyophilization to evaluate the relationship between the resistance to water vapor flow through the dried layer and the microstructure of the dried cake. Recombinant humanized antibody HER2 (rhuMAb HER2) formulated in trehalose was studied, as were… CONTINUE READING
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