Pat Tools for Biologics: Considerations and Challenges

  • Molony M
  • Undey C
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Abstract

This chapter contains sections titled: * Introduction * Cell Culture and Fermentation PAT Tools * Purification PAT Tools * Formulation PAT Tools * PAT Tools for Bioprocess Starting Materials, Defined Media, and Complex Raw Materials * Chemometrics and Advanced Process Control Tools * The power of PLS and PCA * “Relevant Time” Column Integrity Monitoring (Moments Analysis versus HETP) * Challenges for Implementation of PAT Tools * Future PAT Tools * Acknowledgments * References

Author-supplied keywords

  • Cell culture and fermentation PAT tools
  • Chemometrics and advanced process control tools
  • Process analytical technology (PAT) tools for biologics-considerations and challenges

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Authors

  • Michael Molony

  • Cenk Undey

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