The Department of Chemical and Biological Engineering Spring Seminar will be held on Wednesday, March 2, 2022 from 3:15-4:30 p.m. Thomas D. Roper, Ph.D., professor and director of pharmaceutical engineering at Virginia Commonwealth University, will give a lecture titled “Designing the Factory of the Future: Pharmaceutical Engineering Models for Automated Processes.”
The event will be held online via Zoom at this link:
https://iit-edu.zoom.us/j/87129590780?pwd=SkJyOVJOY3JkTThPRTEwMzBPTW9NUT09
Meeting ID: 871 2959 0780
Passcode: 355823
March 2, 2022, 3:15-4:30 p.m.
“Designing the Factory of the Future: Pharmaceutical Engineering Models for Automated Processes”
Biography
Thomas D. Roper, Ph.D.
Professor and Director of Pharmaceutical Engineering
Department of Chemical and Life Science Engineering, Virginia Commonwealth University
Professor Thomas Roper is a professor in the Chemical and Life Science Engineering Department at VCU and Director of Pharmaceutical Engineering. His team’s expertise is in the development of novel syntheses and continuous processes including PAT implementation, as well as empirical and dynamic modeling. Currently the Roper lab is responsible for working within the Medicines for All team to develop CM for pharmaceuticals and transfer them to the Phlow corporation for implementation. Dr. Roper was the PI for the technology transfer portion of the Pharmacy on Demand (PoD) project (post MIT) where his team successfully modified the previous CM process to ensure production of ciprofloxacin to meet regulatory standards for purity. Prior to this Dr. Roper had a lengthy career at GlaxoSmithKline Pharmaceuticals (GSK) where he held a number of scientific and organizational leadership positions including the Global Head of Exploratory Development Sciences.
Abstract
The FDA has long been supportive of and encouraging for the implementation of continuous pharmaceutical manufacture. Nevertheless, the instances of implementation of continuous manufacturing processes to produce both API and formulated product remains low and in 2020 the FDA’s Janet Woodcock commented that there had only been a single instance of a regulatory file which utilized a continuous process to produce API. The reasons for this will be discussed, and these point the way to where additional work and technologies are needed. One of these barriers is the need to reduce human capital associated with pharmaceuticals production. Our attempts at model-based advanced process control will be outlined. Our team has successfully implemented two types of modeling for the ultimate implementation of process control. A PAT based empirical model has been developed to monitor process quality and a first principles model which relies on equipment performance has also been implemented. The initial application of the models on a system for collection and diversion of in-specification and out of specification product will be described. The implications of these results for our ultimate goal of a fully automated advanced process control manufacturing platform will be outlined.