Continuous manufacturing (CM) has been a critical research area in the pharmaceutical industry for the past decade and has been recognized as promising technology by the US Food and Drug Administration (FDA) and other regulatory agents around the world. With intensive collaboration among regulatory agencies, leading industrial players and academia, a large number of data-driven and first principle models have been developed to guide the design and simulation process and lead the implementation of CM for new and existing molecules.
At the same time there is a tremendous amount of work in developing algorithms and approaches that can transform the huge volume of data generated for the entire manufacturing cycle to invaluable information. The integration of those tools together with process systems engineering tools can lead to understanding of process dynamics and the effects of all the different factors, to achieve reliable process performance and ensure acceptable consistent product quality.
Our group has worked over the last 10 years on the development of such models and implementation of advanced process systems engineering analysis tools to enable the adoption of this technology by pharmaceutical industry. The major challenges to achieve this goal, and highlights of the work for the design of the continuous direct compaction (DC) line for the production of solid-based drugs will be covered in the talk.
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). 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) energy and sustainability process modeling and operations; and 4) modeling of 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 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 has also been appointed as a Consultant to the FDA under the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, elected as a fellow of AICHE and as a Director in the board of AIChE.