Forced degradation of therapeutic proteins.

  title={Forced degradation of therapeutic proteins.},
  author={Andrea Hawe and Michael Wiggenhorn and Marco van de Weert and Joerg H O Garbe and H. Mahler and Wim Jiskoot},
  journal={Journal of pharmaceutical sciences},
  volume={101 3},
The scope of this paper is to review approaches used for forced degradation (synonym, stress testing) of therapeutic proteins. Forced degradation studies play a central role in the development of therapeutic proteins, for example, for candidate selection, molecule characterization, formulation development, assay development, and comparability studies. Typical stress methods are addressed within this review, such as exposure to elevated temperatures, freeze-thawing, mechanical stress, oxidation… CONTINUE READING
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