Developing membrane platform technology for manufacturing of clinical-grade bioproducts

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Biomanufacturing processes often contain three major components, namely upstream strain development, midstream cell cultivation, and downstream purification processing. Biological cells with an enhanced ability for the production of desired bioproducts, either ribosomal or non-ribosomal, are isolated or genetically constructed. They are then cultivated in bioreactors for multiplication. Following cultivation, a series of downstream processing steps are adopted for bioproduct purification. While construction of production strains is generally recognized as a key prerequisite for successful bioprocess development, downstream processing could account for a big portion of the capital and operation costs of the overall bioprocess. Hence, developing strategies for effective downstream processing becomes a challenging task for bioengineers. Nysa Membrane Technologies, Inc. is a Canadian company in possession of a novel, proprietary membrane-based platform technology with broad global applications in protein purification and other biological and industrial separations. By establishing the hydrogel technologies which can complement technical limitations associated with pure polymeric membranes, the company has so far developed several hydrogel membrane products for clarification (i.e. microfiltration), chromatography (i.e. anion/cation exchange), and concentration (i.e. ultrafiltration) steps. These products have special features, such as high flux, high binding capacity, and high mechanical strength, based on which they are able to outperform many existing commercial products. Recognizing the lack of commercial membrane products practically applied for manufacturing of clinical-grade bioproducts, the company is interested in commercializing their products by targeting the global market in biopharmaceutical and plasmid DNA manufacturing. To this end, the company will need to establish their platform technology as a superior alternative to the conventional one for bioproduct purification. This is the primary goal of the proposed project, a collaborative work between Nysa and University of Waterloo.