Abstract:

Recent experiments on Vertex’s development and launch rig (DLR) have purposefully varied content to determine the accuracy of residence time distribution (RTD) models on predicting output component concentrations.  The variation in content also affected the observed parameters during tablet compression.  This presentation will explore the sensitivity of the compression parameters during the RTD experiments to the change in content and investigate the accuracy of using mixture models with compaction simulator data on predicting that sensitivity. A framework on integrating the compression parameter predictions with the RTD model content predictions to assess manufacturing performance will be presented.

Bio:
Steven is a Senior Principal Research Scientist at Vertex Pharmaceuticals who has been working to transfer new chemical entities to a continuous manufacturing process for the last 8 years.  His work has included transfers of continuously wet granulated and dry granulated products, both receiving regulatory approval for manufacture in Boston.  Prior to working at Vertex, he characterized wet granulation processes within Jim Lister’s and Carl Wassgren’s powder and compact characterization lab at Purdue University.