Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

CANCELLED - TL10: Statistical Considerations in Scale-Down Model Qualification (300625)

*Hesham Fahmy, AbbVie 

Keywords: Scale-down models, process validation

Scale-down models (SDMs) are essential to support process validation studies, and troubleshooting of scaled-up process operations throughout the biopharmaceutical industry. To support such studies, regulatory guidelines state that SDMs should represent the commercial process. In this roundtable, we can present challenges and statistical approaches to qualify SDMs. We can also discuss common questions asked by scientists involved in conducting SDM studies.