The combination of continuous manufacturing (CM) and small scale development characterization has enabled rapid development timelines and allowed for delayed determinations of clinical quantity needs. In less than one year, a pre-FHD compound at Eli Lilly advanced from gram quantities of development API to commercial scale tablets for Phase I Clinical Trials. The initial gram quantities of API, of varying particle size distributions, were evaluated and compared in formulated tablets formed on a single station press. Results were used to determine particle size targets for increasing the scale of API manufacture. With low kilogram quantities of scaled-up API available, small demonstration drug product batches using a CM direct compression platform on a rotary press were successfully completed, and tablets were then coated for development stability. The demonstrated development process was transferred to a GMP facility and CT batches were manufactured at commercial scale, occurring within a year of the initial gram scale development assessments.
