Identifying and Managing Sources of Variability in Cell Therapy Manufacturing and Clinical Trials

@article{Silverman2019IdentifyingAM,
  title={Identifying and Managing Sources of Variability in Cell Therapy Manufacturing and Clinical Trials},
  author={Lara Ionescu Silverman and Flagg Flanagan and Daniel Rodriguez-Granrose and Katie Simpson and Lindsey Hart Saxon and Kevin T. Germantown Foley},
  journal={Regenerative Engineering and Translational Medicine},
  year={2019},
  pages={1 - 8}
}
Identifying and managing cell therapy variability can be a significant challenge for a company seeking to commercialize a new product. Failure to address this issue can lead to negative consequences such as delayed approval due to unsuccessful clinical investigations, or failed product lots that do not meet release criteria. Allogeneic cell therapies can be particularly prone to variability challenges due to the use of variable input material. In order to support the manufacturers of cell… CONTINUE READING