Characterization of antibody variants during process development: the tale of incomplete processing of N-terminal secretion peptide.

@article{Ambrogelly2012CharacterizationOA,
  title={Characterization of antibody variants during process development: the tale of incomplete processing of N-terminal secretion peptide.},
  author={Alexandre Ambrogelly and Y Liu and Hong Li and Selina Mengisen and Bingyi Yao and Wei Xu and Susan V. Cannon-Carlson},
  journal={mAbs},
  year={2012},
  volume={4 6},
  pages={701-9}
}
Monoclonal antibodies (mAbs) have emerged as one of the most important classes of biotherapeutics, although development of these molecules is long and arduous. A production cell line must be established, and growth conditions for the cells and purification processes for the product must be optimized. Integration of the appropriate analytical strategies in these activities is the cornerstone of Quality by Design and in-process control approaches are encouraged by the Food and Drug Administration… CONTINUE READING

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