Prof. Ranil Wickramasinghe
Distinguished Professor et Directeur du Membrane Science, Engineering and Technology Center
University of Arkansas,

Mondy, July 1st 2024

Development of Membrane Based Bioseparations
for Emerging Purification Challenges

Biopharmaceutical manufacturing processes make use of cell lines to produce therapeutics such as monoclonal antibodies, fusion proteins etc. The manufacturing process is divided into upstream cell culture and downstream purification operations. Today, due to improvements in cell titers there is increased demand for the development of efficient downstream purification operations. Membrane based unit operations are attractive as they are easy to scale up and often involve gentle processing conditions. Nevertheless, low product recovery as well as membrane fouling remain a concern.

This presentation is divided into two parts. In the first part common membrane based unit operations will be identified. In particular the benefits of membrane adsorbers over packed bed chromatography will be highlighted. The advantages of using salt responsive ligands for membrane based hydrophobic interaction chromatography will be discussed.

In the second part of this presentation future trends in biopharmaceutical manufacturing processes will be discussed. Today, biopharmaceutical manufacturing processes are typically run in batch mode. Further there is growing interest in complex therapeutics, e.g., live attenuated virus vaccines, viral vectors for delivery of gene therapy, VLPs, plasmid DNA, cell-based therapies. These more complex therapeutics create additional challenges for the downstream purification operations. Some of these challenges will be discussed. In addition, there is a great deal of interest in developing continuous biomanufacturing processes in order to minimize batch to batch variation. Continuous biomanufacturing processes will result in more efficient equipment usage as well as greater flexibility. While advances have been made in continuous upstream cell culture operations (e.g., perfusion operations) many downstream purification operations remain batch processes.

Membrane based bioseparations are run in batch mode. Development of continuous membrane based bioseparations is essential. The presentation will highlight virus filtration. Virus filtration is routinely used for validation of virus clearance in the manufacture of biopharmaceutical products. Validation of virus clearance is required by regulatory agencies. However, development of virus filtration operations that are compatible with continuous biomanufacturing operations will be essential. Our results indicate that development of membranes that are compatible with constant flux operation as opposed current practice which is based on constant pressure operation will be required

Bio: Ranil Wickramasinghe is a distinguished professor in the Department of Chemical Engineering at the University of Arkansas where he holds the Ross E Martin Chair in Emerging Technologies. He is an Arkansas Research Alliance Scholar. He is the Director of the Membrane Science, Engineering and Technology (MAST) Center, a National Science Foundation Industry-University Cooperative Research Center. Prof Wickramasinghe is the Executive Editor of Separation Science and Technology. Prof Wickramasinghe obtained his bachelor’s and master’s degrees from the University of Melbourne in Chemical Engineering. He obtained his PhD from the University of Minnesota, also in Chemical Engineering. Prof Wickramasinghe’s research interests are in membrane science and technology. His research focuses on synthetic membrane-based separation processes for purification of pharmaceuticals and biopharmaceuticals, treatment and reuse of water and for the production of biofuels. Typical unit operations include: microfiltration, ultrafiltration, virus filtration, nanofiltration, membrane extraction, membrane distillation etc. A current research focus is surface modification of membranes in order to impart unique surface properties. His group is actively developing responsive membranes. These membranes change their physical properties in response to changed environmental conditions. A second research focus is the development of catalytic membranes for biomass hydrolysis by grafting catalytic groups to the membrane surface.

Conference: Prof. R. WICKRAMASINGHE – 1/7/2024
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