(342c) Characterizing a Drug Product Continuous Manufacturing Platform’s Residence Time Distribution Using Major and Minor Unit Formula Excipient Step Changes and Soft Sensors

A continuous manufacturing (CM) lineâ??s residence time distribution (RTD) must be appropriately characterized to provide product traceability in the event of a process upset or when switching raw material batches. Lillyâ??s current process to determine the CM lineâ??s RTD is to characterize the final blend concentration versus time as a result of intentional step changes to ingredient concentration in the formula. Currently, the ingredient concentration is determined using a Near-infrared (NIR) application located in the tablet press feed frame. This presentation explores 1) using step changes in either the major and/or minor excipient ingredients in the formula to produce similar concentration response curves in the feed frame using the NIR application and 2) the option to use soft sensors in lieu of the NIR application to characterize the CM lineâ??s response to the ingredient step changes and ultimately determine its RTD.