SBIR Phase II: High Throughput Static Light Scattering Platform for Monitoring of Aggregation and Stability of Protein Solutions

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project, if successful, will have immediate value for the pharmaceutical industry by accelerating research and discovery of new drugs, and also increasing production efficiency and safety. The technology also is applicable in many other sectors; e.g., monitoring natural polymers, such as dissolution of gelatin used in food or pharmaceutical applications, flocculation of impurities by water purification polymers, entrapment of oil by surfactants and other agents used in combating oil spills, and more. The quantitative kinetics of molecular weight changes during all these processes will allow deeper understanding of the fundamental physical and chemical forces that drive them. Therefore, many commercial and scientific opportunities exist for the proposed technology, yielding the potential for significant impact across multiple industries. With demonstrated feasibility on applications in protein therapeutics and early adoption by several key users, the initial market for this technology and instrumentation could expand quickly, and sales could reach $10M within several years of delivering a commercial product. The overall market for the technology will increase in time as other application sectors are developed. This SBIR Phase II project proposes to develop a new technology for monitoring aggregation in therapeutic protein solutions, which will have wide-ranging impact in the pharmaceutical and biotechnology industries. Protein aggregation is a major problem across these sectors engaged in developing new protein pharmaceuticals. Protein aggregation can elicit immune responses against the protein itself, severely reduce bioavailability, and is a significant hurdle in the drug development pipeline. This new technology can simultaneously and quantitatively monitor the stability of many independent protein formulations for hours, days, months, or longer, all under the control of a single instrument and without any significant human intervention. Because the technology is based on laser light scattering, it provides a rigorous means of monitoring the protein aggregation process. It is based on fundamental laws of physics, and not on empirical or inferential means. The implementation and use of this technology could revolutionize drug discovery, formulation, and quality control dimensions and accelerate development of new drugs while making existing ones safer and more efficiently produced. The technology can be used wherever proteins are under development for fighting diseases such as cancer, Alzheimer's, diabetes, and various forms of cardiovascular disease.