Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway.

@article{Barnard2011SubvisiblePC,
  title={Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway.},
  author={James G Barnard and Satish Singh and Theodore W. Randolph and John F. Carpenter},
  journal={Journal of pharmaceutical sciences},
  year={2011},
  volume={100 2},
  pages={492-503}
}
The objective of this study was to evaluate microflow imaging (MFI) as a sensitive tool to detect and quantify subvisible particle formation during freeze-thawing of an IgG(2) monoclonal antibody (mAb). Solutions of the protein formulated in 20 mM of histidine buffer (pH 5.5) were subjected to three freeze-thaw cycles and analyzed by MFI and size-exclusion chromatography (SEC). MFI showed increased particle numbers after each freeze-thaw cycle, whereas aggregates were not detected by SEC… CONTINUE READING

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