Manufacturing & Analytical Characterization – Chemical
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Robert Yule
Head of Operations, Data and Modeling
Sanofi
Malvern, Pennsylvania
Sayantan Chattoraj, Ph.D.
Director & GSK Fellow, Drug Product Development
GSK
Collegeville, Pennsylvania
A vision for accelerating Oral Solid Dosage Drug Product development using material science and simulation will be discussed. These efforts are intended to; align with current portfolio needs, enable future simplification of manufacturing platforms, and explore opportunities to frontload work in early development.
The first part of the presentation will describe the current state of Digital Development at Sanofi. Most of our efforts are focused on developing Digital Twins of manufacturing processes. An integrated system model for roller compaction and in-vitro dissolution will be presented. This will include a high-level discussion on the modeling approaches and material science testing needed to build models.
To conclude, the short and long term vision for improving modeling and material science at Sanofi will be outlined. Included will be an assessment of the gaps in material science and modeling knowledge needed to achieve our visions. There will also be a projection of potential benefits for Digital Development implementation.