Industrial Perspectives on Mixing in a Continuous Direct Compression Manufacturing Process
Wyatt Roth, Ph.D. – Principal Research Scientist, Small Molecule Design and Development – Eli Lilly and Company
Eli Lilly is an industrial leader in drug product continuous manufacturing with replicated continuous direct compression (CDC) lines in development and manufacturing. Lilly focuses on CDC as its default small molecule manufacturing platform due to several advantages relative to continuous granulation technologies including fewer unit operations, increased development efficiency, and an overall simplified process control strategy. In addition to these advantages, Lilly has also demonstrated the robustness of continuous mixing through proof of concept studies which focused on content uniformity for a broad range of drug substance and formulation properties. This presentation will highlight those studies as well as Lilly’s comprehensive control strategy to ensure adequacy of mixing in the CDC lines.
Wyatt Roth is a principal research scientist within the Small Molecule Design and Development organization at Eli Lilly and Company, Indianapolis, IN. He received B.S. degrees in Pharmaceutical Sciences and Agricultural and Biological Engineering from Purdue University in 2008, and earned his Ph.D. in Industrial and Physical Pharmacy from Purdue University in 2012. Upon joining Lilly in 2012, Wyatt led numerous continuous manufacturing feasibility and process optimization studies which influenced the decision to build Lilly’s first GMP drug product continuous manufacturing facility. Since that time, he has served as the lead development scientist for Lilly’s first two assets which used a continuous manufacturing platform where he led the design and execution of multiple studies to understand the impact of raw material properties on loss in weight feeder performance, determine the impact of process parameters on the robustness of continuous mixing, and understand the enhanced capability of continuous direct compression relative to batch manufacturing. Wyatt also has expertise in control strategy development and technical transfer from development to commercial manufacturing sites for continuous direct compression manufacturing processes culminating in the approval of Lilly’s first drug product which uses a continuous manufacturing platform.