STTR Phase I: Development of a Novel Microfluidic Technology for Discovery of Affinity Binders

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This Small Business Technical Transfer (STTR) Phase I project will demonstrate the potential for developing a novel affinity binding reagent screening technology. Synthetic affinity binding reagents can improve on immunoglobulin-based antibodies. For example, synthetic affinity binding reagents are much smaller, far more stable, less costly to develop, and more soluble than immunoglobulin-based antibodies. Moreover, synthetic affinity binding reagents can be created in vitro (no vertebrate animal research is required). Typical screening technologies require immobilizing a purified antigen target (the display component), and physically connecting the affinity binder genotype and phenotype. These requirements can limit the effectiveness of the screen. In contrast, this project will develop a novel proprietary technology that screens for affinity binders in solution using microfluidic in vitro compartmentalization and a homogeneous assay. The research will result a system that can discover, within a relatively short time, tens to hundreds of affinity binders that have genuine utility to label, identify, capture, stabilize, crystallize, and quantify specific biomolecules.The broader impact/commercial potential of this project, if successful, will be new affinity binding reagents for life science research, diagnostics, and biopharmaceutical applications. Research antibodies have dominated the Life Sciences Research market for many years (approximately $1.6 billion in sales worldwide) and include applications such as immunoassays (e.g., ELISA), immunohistochemistry, western blot analysis, and lateral flow assays. However, immunoglobulins are challenging and time-consuming to create and purify, because they require animal hosts. Most affinity binding reagents are highly stable (possibly room temperature storage), uniform, specific, and reproducible. In addition, these affinity reagents will be useful for reversibly capturing native biomolecules or biomolecular complexes, capturing native proteins for mass spectrometric immunoassays, and as chaperones for determining protein crystal structures. These affinity binders will become a very important component of In Vitro Diagnostic (IVD) immunoassays ($10 billion worldwide market), therapeutic drug monitoring, and multiplexed immunoassays in point-of-care devices. The most prominent and profitable market for the affinity binders will be biopharmaceuticals ($50 billion antibody worldwide market). Investment in monoclonal antibodies has resulted in 5 blockbuster and dozens of other valuable therapeutics. Investment in synthetic affinity binders will expand this potential.