Abstract: The first part of the talk will focus on recent developments in membranes as alternatives to column chromatography for product capture and purification of protein therapeutics, vaccines, oligonucleotides and gene therapy, as well as the application of more established membrane processes such as micro- and ultrafiltration for the isolation of extracellular vesicles (EVs). Novel membrane fabrication approaches enable the production of chromatographic membranes with high surface area but high porosity (80-85%), resulting in flow permeabilities more than an order of magnitude higher than those of resin-packed process chromatography columns. This allows for high superficial velocity process operations (residence times < 1 minute) with low pressure drops. These processes can include rapid cyclic bind-and-elute steps using small volume devices, flow-through operations for polishing, and modular cassette membrane systems for scale-up. An overview of recent work performed in our laboratories for the purification of various biologics will be discussed. Two different case studies will be presented: the purification of viral vectors (AAV2) and an all-membrane process for the purification of monoclonal antibodies. The two examples are very different in scale and target and give an idea of the wide range of applications for membrane chromatography. In another research effort, we introduced a scalable and cost-effective membrane-based filtration process to isolate EVs from various sources for drug delivery applications. An integrated membrane process was applied to two novel sources of EVs, lemon juice and milk whey, a by-product of cheese production. The process consists of a preliminary clarification followed by constant volume continuous ultrafiltration/diafiltration (UF/DF) and ultrafiltration/concentration (UF) performed with hollow fiber modules. After optimization of the filtration conditions, including membrane types, molecular weight cut-offs, filtration modes, as well as membrane fouling reduction strategies, the process was applied for simultaneous purification of EVs impurities and removal of unbound drugs, combining two challenging downstream processes into one. Curcumin was used as a model drug and loaded onto whey EVs to develop the drug delivery system. Curcumin-loaded whey EVs were purified using the same integrated MF/UF/DF process. Overall, this scalable membrane-based process for isolating and loading EVs significantly enhances the potential for industrial and clinical translation of EV-based therapies.
Bio: Cristiana Boi is an Associate Professor of Chemical Engineering at Alma Mater Studiorum-Università di Bologna, Italy and a Research Associate Professor in the Department of Chemical and Biomolecular Engineering at North Carolina State University in Raleigh, NC, USA. She holds the Italian Habilitation as Full Professor for the academic field 09/D2-Systems, methods and technologies of chemical and process engineering. She graduated in Chemical Engineering from the University of Bologna in 1991 and obtained her Ph.D. in Chemical and Environmental Engineering from the University of Bologna in 1996, with a joint project with Rensselaer Polytechnic Institute, Troy NY, USA. Her research interests are in downstream processing in biotechnology with a focus on membranes and chromatographic processes for highly selective separations. In particular, she is interested in the preparation, modification and characterization of functional materials for bio-separations, biomedical applications, water purification and the production of biopharmaceuticals. Cristiana Boi has published 54 articles in high-impact peer-reviewed journals, 3 book chapters and presented more than 130 papers at international conferences. She is an Editor for Separation and Purification Technology and member of the editorial board of Membranes. She has supervised/co-supervised 9 Ph.D. students and 74 MSc students and is currently supervising 5 Ph.D. students and 8 MSc students. She has been the President of the European Membrane Society for 2017 and 2018, the Funding Secretary of the World Association of Membrane Societies for 2017-2020, and is the current Chair of the Area 2G, Bioseparations, of the AIChE.
Details:
Date: Thursday, April 10, 2025
Time: 11:00 AM CDT
Location: Bell 2269
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