SBIR Phase II: Enzyme-based Magnetic Catalysts for Active Pharmaceutical Intermediates (APIs) Manufacturing

The broader commercial potential of this Small Business Innovation Research Phase II project is the commercial development of novel materials and processes for the immobilization of enzymes. The project is targeting enzymes as catalysts to be used in the manufacturing of active pharmaceutical intermediates (API). The use of enzyme for the production of pharmaceuticals has the potential to reduce cost, complexity and improve efficiency in making these products. The green, cost-efficient and scalable oxidative immobilized enzymes will benefit manufacturers by improving their production efficiencies and economics as well as minimizing adverse environmental impact. The technology could make benign oxidative enzymes commercially competitive replacing expensive precious metal catalysts, toxic, or other hazardous chemicals used in the production processes for APIs. The industrial applications for this technology could be broad well beyond the pharmaceutical arena. The technical objectives of this Phase II research project are to (1) develop oxidative enzyme constructs and biocatalytic schemes for the production of high-value commercial active pharmaceutical ingredients (APIs), (2) develop and produce magnetic macroporous scaffolds, and (3) improve operation of commercial reactors for continuous flow manufacturing or retrofit existing production processes using these magnetic catalysts with immobilized enzymes. This project enables immobilization to become a part of the selection process: enzymes can be selected for their true potential in their immobilized form by engineering enzyme immobilization with three levels of innovation: entrap commercially-available or third-party engineered enzymes into magnetic nanoclusters; create high-surface area scaffolds that stabilize the magnetic nanocluster assemblies, providing cost and process advantages of maintaining the nanocluster assemblies in suspension magnetically. This project is focusing on a high-potential, well-described and commercially available enzyme from the oxidoreductase family that will be used the synthesis of drug intermediates by enzyme-producers and enzyme-end users in the pharmaceutical sector.