Quality by design for biopharmaceuticals

@article{Rathore2009QualityBD,
  title={Quality by design for biopharmaceuticals},
  author={Anurag Singh Rathore and Helen Winkle},
  journal={Nature Biotechnology},
  year={2009},
  volume={27},
  pages={26-34}
}
The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics. 

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