Abstract
AbstractThe development and application of continuous-flow drug-substance manufacturing at Eli Lilly is described. A series of examples are provided in which a continuous process was developed to solve problems associated with an existing batch process. The three distinct areas of focus are: facilitation of early phase delivery, hybrid batch/flow processes at manufacturing scale, and small-volume continuous manufacturing (linked multiunit operation processes at 10 kg/day throughput). An overview is provided of the types of reactors implemented in our program and the chemistries they enable. The use of online process analytical technology is also described for each of these systems. Special emphasis is placed on the examples pertaining to increased safety and improved product quality gained from flow processing.