Application of QbD in biotechnology
- At: 2008 FIP Congress in Basel (Switzerland)
- Type: Presentation
- By: ADVANT, Siddharth (Sid) (Tunnell Consulting, San Diego, United States of America)
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... The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.