Zhenqi Shi, Ph.D.

Real-time analytics in Material characterization: Current trends and prospective

Real-time analytics in Material characterization: Current trends and prospective

Since the PAT guideline was issued by FDA back in 2004, the use of real-time analytics (RTA) has been penetrating through a wide array of aspects of pharmaceutical development and manufacturing. The advent of continuous manufacturing and adoption of such in the new pharmaceutical manufacturing paradigm continue illustrating the critical role played by real-time analytics in both development and manufacturing, from crystallization to blending, from granulation to tablet compression, from encapsulation to tablet coating. Thus, the talk is not only intended to survey the best practice on the field of using RTA to perform material characterization either on in-process material or finished products, but also highlight those challenges and opportunities on using RTA to serve the intended purpose of either in-process control (IPC) or real-time release testing (RTRt).

Dr. Shi graduated from Duquesne University in 2009, majoring in pharmaceutical sciences. After a two-year industrial postdoc, he landed a job in Lilly. Since then, he has been working on process monitoring, control and optimization using a variety of analytical and modeling tools. He has developed and deployed multiple PAT-based monitoring system for commercial manufacturing, notably a real-time monitoring and control platform for Lilly’s first continuous manufacturing process on drug product. Concurrently, he published over 25 peer-reviewed articles and delivered over 30 presentations on the field of spectroscopy, PAT and chemometrics. He has also been chairman and moderator for multiple PAT related symposiums in AAPS and IFPAC.