Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing.

@article{Kueltzo2008EffectsOS,
  title={Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing.},
  author={Lisa A. Kueltzo and Wei Wang and Theodore W. Randolph and John F. Carpenter},
  journal={Journal of pharmaceutical sciences},
  year={2008},
  volume={97 5},
  pages={1801-12}
}
Freeze-thawing is a potentially damaging stress to which therapeutic proteins can be exposed deliberately during storage of bulk drug substance, and accidentally because of mishandling of commercial product during shipping and/or storage. The primary route of degradation induced by freeze-thawing is protein aggregation. We studied the effects of freeze-thawing on aggregation of an IgG2 monoclonal antibody, examining solution conditions (pH, and the presence or absence of 150 mM KCl), protein… CONTINUE READING

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