Purifying biopharmaceuticals: knowledge-based chromatographic process development.

  title={Purifying biopharmaceuticals: knowledge-based chromatographic process development.},
  author={Alexander Thomas Hanke and Marcel Ottens},
  journal={Trends in biotechnology},
  volume={32 4},
The purification of biopharmaceuticals is commonly considered the bottleneck of the manufacturing process. Increasing product diversity, along with growing regulatory and economic constraints raise the need to adopt new rational, systematic, and generally applicable process development strategies. Liquid chromatography is the key step in most purification processes and a well-understood unit operation, yet this understanding is still rarely effectively utilized during process development… CONTINUE READING

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