(331a) Keynote: Novel Approach for Elucidating Structure/Property Relationships in Self-Assembled Isoporous Membranes Used in Biopharmaceutical Separations

Recent progress in the field of bio-therapeutic molecules is driven largely by the discovery and development of novel biomolecular constructs, such as cell and gene therapies, lipid-based delivery systems, and bispecific antibodies. In parallel to these exciting therapeutic systems, correspondingly advanced and novel manufacturing capabilities are required, especially in regard to the large-scale separation of the valuable therapeutic agent from inactive and potentially dangerous by-products. As example is the viral clearance step in the production of monoclonal-based drugs, where a precise size exclusion mechanism is needed to retain adventitious viruses, which are slightly larger than the drug product. One such separations platform is an isoporous membrane with precise pore size control, homogenous surface chemistry, and well-defined sub-structure. These new membrane materials cannot be adequately characterized using traditional methods. For example, conventional bubble point solvents are not always compatible with the membrane materials, and static microscopy imaging techniques suffer from both hyper-localization and ex-situ characterization. In this presentation, we will provide an overview of triblock terpolymer isoporous membranes and their applications to bioprocess, as well as in-situ simple and insightful characterization methods that facilitate our understanding of structure/property relationships in this unique material.