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Quality by design in freeze-drying process development for biopharmaceuticals.

Author(s) : WANG D. Q.

Summary

In this article, rFVIII is used as an example of biopharmaceutical products. rFVIII is a therapeutic protein for the treatment of Hemophilia A with 2332 amino acids and a molecular weight of more than 300 KD. So far the rFVIII is the largest and the most instable protein genetically engineered by biopharmaceutical industry. For such a high value product, consideration of quality by design in the freeze-drying process development is a good strategy to ensure consistency of the process and quality of the product. This article describes that the critical process steps and process parameter ranges were selected and tested either at laboratory scale or large production scale. Testing result demonstrates the robustness of the freeze-drying process developed for a large scale production.

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Pages: 2007-3

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Details

  • Original title: Quality by design in freeze-drying process development for biopharmaceuticals.
  • Record ID : 2008-2757
  • Languages: English
  • Source: New Ventures in Freeze-Drying
  • Publication date: 2007/07

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