Abstract

The $600 billion/year pharmaceutical industry is an important sector in which the U.S. remains a global leader. In the last few years, however, there has been growing recognition that the industry is facing a crisis. Indeed, the Critical Path Initiative of the FDA has identified the lack of innovation in pharmaceutical manufacturing science as one of the key impediments to the delivery of safe and cost-effective medicines to the patient.

There are a number of challenges that the industry faces in order to transition towards more competitive, systematic and efficient manufacturing. Regulatory authorities have recognized the deficiencies of pharmaceutical product manufacturing and aim to enhance process understanding through Quality by Design (QbD) and Process Analytical Technology (PAT) tools. As a result of this current effort to change the mindset in order to mimic the rest of the chemical industry, an additional transition is becoming more and more appealing: production from batch to continuous mode. However, continuous manufacturing 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, computer aided dynamic simulation toolswill allow the design, analysis and optimization of continuous integrated processes.

In this talk I will discuss the work that has been done in my lab towards the development of an integrated platform that will enable the efficient flowsheet simulation and analysis, the assessment of design alternatives, the feasibility analysis of the production line, and the control and optimization of process design and operations.

Biography

Marianthi Ierapetritou is a Professor in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. She obtained her BS from National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998.

Prof. Ierapetritou’s research focuses on the following areas: 1) Process operations; (2) design and synthesis of flexible manufacturing systems; 3) modeling of reactive flow processes; and 4) metabolic engineering. She has published over 150 papers, and has presented her research in a number of universities and conferences around the world.

Among her accomplishments is the Outstanding Faculty Award last year, the Rutgers Board of Trustees Research Fellowship for Scholarly Excellence, and the prestigious NSF CAREER award. She is also a member of AIChE, INFORMS and SIAM and an active participant in the scientific advising committees of ESCAPE, PSE, FOCAPD and FOCAPO. Marianthi has been active in CAST division of the AIChE as a program director for the last two years and she was last year elected as a vice chair.