Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes.

@article{Shukla2008DemonstrationOR,
  title={Demonstration of robust host cell protein clearance in biopharmaceutical downstream processes.},
  author={Abhinav A. Shukla and Canping Jiang and Junfen Ma and Michael Rubacha and Lisa Flansburg and Steven S. W. Lee},
  journal={Biotechnology progress},
  year={2008},
  volume={24 3},
  pages={615-22}
}
Residual host cell protein impurities (HCPs) are a key component of biopharmaceutical process related impurities. These impurities need to be effectively cleared through chromatographic steps in the downstream purification process to produce safe and efficacious protein biopharmaceuticals. A variety of strategies to demonstrate robust host cell protein clearance using scale-down studies are highlighted and compared. A common strategy is the "spiking" approach, which is widely employed in… CONTINUE READING