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Application of QbD in biotechnology

  • At: Basel (Switzerland) (2008)
  • Type: Presentation
  • By: ADVANT, Siddharth (Sid) (Tunnell Consulting, San Diego, United States of America)
  • Abstract:

    The role of QbD in biotechnology is still evolving. Although companies have used DOE and PAT in process development and process characterization, their role in QbD- specifically to provide regulatory relief is still unclear. This presentation will discuss the current thinking and future potential of how QbD can be used in regulatory submissions.


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Last update 4 October 2019

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