Dr. Zhixun Wang, Merck Process Research and Development, Rahway, NJ

Title: Commercial manufacturing process for Enlicitide Decanoate, a “large” small molecule

Abstract: Enlicitide decanoate emerges as a promising oral inhibitor for PCSK9 pathway, which plays a vital role in controlling elevated low-density lipoprotein (LDL) cholesterol levels. Due to the compound’s structural complexity, its synthesis poses considerable challenges, making the development of efficient commercial manufacturing processes essential. In this presentation, we will introduce innovative chemo and enzymatic approaches for the rapid construction of the macrocyclic polypeptide and detail the strategy behind its development. We will also discuss the obstacles faced during scale-up and the solutions implemented to address them. By sharing insights from this case study, we aim to advance the broader understanding of commercial process development for complex pharmaceutical molecules.

 Biosketch: Zhixun Wang joined the Merck Process Research & Development Department in 2019. His research focuses on designing and optimizing manufacturing routes for drug candidates and commercial products. He received his B. S. degree from Fudan University, and then obtained his Ph.D. under the supervision of Professor Liming Zhang at University of California, Santa Barbara with a research focus on homogeneous gold catalysis. Zhixun then moved to New Haven, CT, where he did postdoctoral work on synthesis of pleuromutilin analogs and structure elucidation of colibactin with Professor Seth Herzon in Yale University.