Effect of cell culture medium components on color of formulated monoclonal antibody drug substance.

@article{Vijayasankaran2013EffectOC,
  title={Effect of cell culture medium components on color of formulated monoclonal antibody drug substance.},
  author={Natarajan Vijayasankaran and Sharat Varma and Yi Yang and Melissa Mun and Silvana R Arevalo and Martin Gawlitzek and Trevor E. Swartz and Amy J. Y. Lim and Feng Li and Boyan Zhang and Steve Meier and Robert D Kiss},
  journal={Biotechnology progress},
  year={2013},
  volume={29 5},
  pages={1270-7}
}
As the industry moves toward subcutaneous delivery as a preferred route of drug administration, high drug substance concentrations are becoming the norm for monoclonal antibodies. At such high concentrations, the drug substance may display a more intense color than at the historically lower concentrations. The effect of process conditions and/or changes on color is more readily observed in the higher color, high concentration formulations. Since color is a product quality attribute that needs… CONTINUE READING
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