Strategies for developing design spaces for viral clearance by anion exchange chromatography during monoclonal antibody production.

@article{Strauss2010StrategiesFD,
  title={Strategies for developing design spaces for viral clearance by anion exchange chromatography during monoclonal antibody production.},
  author={Daniel M Strauss and Tony Cano and Nick Cai and Heather Delucchi and Magdalena Plancarte and Daniel T Coleman and Gregory S. Blank and Qi Chen and Bin Yang},
  journal={Biotechnology progress},
  year={2010},
  volume={26 3},
  pages={750-5}
}
The quality-by-design (QbD) regulatory initiative promotes the development of process design spaces describing the multidimensional effects and interactions of process variables on critical quality attributes of therapeutic products. However, because of the complex nature of production processes, strategies must be devised to provide for design space development with reasonable allocation of resources while maintaining highly dependable results. Here, we discuss strategies for the determination… CONTINUE READING

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Elements of quality by design in development and scale-up of freeze-dried parenterals

SL Nail, JA Searles
BioPharm Int • 2008

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