Description:

Marianthi Ierapetritou
Rutgers University

Title:
A Process Systems Engineering Perspective to Advanced Pharmaceutical Manufacturing

Abstract:
Over the past decade, there has been a significant growth of research in modernizing manufacturing processes in the pharmaceutical industry. The main goal is to improve the agility, flexibility, and robustness of the manufacturing process, which is important for solving the drug shortage problems.

The Food and Drug Administration (FDA) has recognized the deficiencies of pharmaceutical product manufacturing and has launched an initiative for enhancing process understanding through Quality by Design (QbD). The major goals of this effort can be summarized into the development of mechanistic understanding of a wide range of processes; harmonization of processes and equipment; development of technologies to perform online measurements of critical material properties during processing; performance of real-time control and optimization; minimization of the need for empirical experimentation and finally, exploration of process design space. As a result of this effort to change the mindset in pharmaceutical manufacturing, transition of the production from batch to continuous mode is becoming more appealing to the industry.

However, continuous production requires detailed process understanding in terms of the evolution of all critical material properties as a function of its operating parameters and environmental conditions. Once process knowledge is translated into models, process systems engineering tools allows the design, analysis and optimization of continuous integrated processes. The major challenges to achieve this goal, and highlights of the work that has been performed in our lab in the recent years to address these problems will be covered in the talk.

Bio:
Marianthi Ierapetritou is a Professor and Chair in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. Dr. Ierapetritou’s research focuses on the following areas: 1) process operations; (2) design and synthesis of flexible production systems focusing on pharmaceutical manufacturing; 3) modeling of reactive flow processes; and 4) metabolic engineering with focus on biopharmaceutical production. Her research is supported by several federal (FDA, NIH, NSF, ONR, NASA) and industrial (BMS, J&J, GSK, PSE, Bosch, Eli Lilly) grants.

Among her accomplishments are the 2016 Computing And Systems Technology (CAST) division Award in Computing in Chemical Engineering, the highest distinction in the Systems area of the American Institute of Chemical Engineers (AIChE), the Award of Division of Particulate Preparations and Design (PPD) of The Society of Powder Technology, Japan; the Outstanding Faculty Award at Rutgers; the Rutgers Board of Trustees Research Award for Scholarly Excellence; and the prestigious NSF CAREER award. She is also appointed this year as a Consultant to the FDA under the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology and elected as a fellow of AICHE and more recently as a Director. She has more than 250 publications, and has been an invited speaker to numerous national and international conferences.

Dr. Ierapetritou obtained her BS from The National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed her post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998.