Overview

Title: Pioneering an Approach to Integrated Continuous Bio-manufacturing
Date: Thursday, June 22, 2017
Time: 10:00 AM Eastern Daylight Time / 16:00 Central European Time (convert to your local time)
Duration: 1 hour

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Summary

Recent improvements of continuous up- and downstream processes suggest their final integration to a single process stream. Besides general benefits of continuous manufacturing, such as reduced equipment size, enhanced cost efficiency and high volumetric productivity, the steady state operation favors the consistency of product quality.

We will present a series of experiments where a perfusion reactor with CHO cells for the production of a monoclonal antibody has been operated in the continuous mode and connected first to a two column continuous protein A chromatographic unit for product capture and subsequently to a continuous two columns MCSGP unit for final polishing. A few steady states are examined and the use of simulation models for process design and control is illustrated.

We investigate the impact of continuous integrated operation on process performance and product quality and compare it with the corresponding classical batch operation. Consistent operation at enhanced product quality of desired therapeutic proteins by precise overall control and optimization is aimed at.

Data from pilot scale work on monoclonal antibodies where bench top work is compared to GMP scale multi-column process is also presented.

About the presenter

Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland).

His main research interests are in chemical reaction engineering, with particular emphasis on polymer reactions and colloidal engineering. This has evolved over the years in developing new processes for the production of polymer particles, ranging from the micro to the nano scale, exhibiting various types of functionalities and physico-chemical characteristics, including bio compatibility and degradation kinetics. Applications in various areas are considered including drug delivery, composite materials and treatment of oil reservoirs.

Massimo Morbidelli is co-author of more than 600 papers, 11 international patents and four books. He serves as an associate editor of the ACS journal of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international scientific journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers and of the 2014 Gerhard Damköhler-Medaille of DECHEMA.and VDI-GVC.