Application of QbD in biotechnology

• In: S6 - Implementation of Quality by Design and Risk Management- overcoming the practical hurdles on Thursday, 4 September 2008, 9:00-12:00
• 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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