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A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Lifecycle Initiative (PQLI®) has worked at the nexus of...
Wyatt J. Roth, PhD
Eli Lilly & Co.
Director
Wyatt Roth is a director 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.
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Continuous manufacturing (CM) offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of continuous manufacturing in enhancing accelerated development, as evidenced by experience in solid oral products.