Optimization of Protein Therapeutic Formulations

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DESCRIPTION (provided by applicant): This proposal involves the development and validation of a novel approach to improve and accelerate the discovery of biopharmaceuticals (i.e. vaccines, monoclonal antibodies and other therapeutic proteins). Biopharmaceuticals are used to treat a variety of infectious and chronic diseases. The proposed research is intended to establish a new paradigm for rapidly improving the solubility and physical stability of biopharmaceuticals. The paradigm will be evaluated using one or more vaccine candidates obtained from a pharmaceutical company as well as the protein osteoprotegerin (OPG), which is involved in bone mineralization and osteoporosis. According to the latest Data-Monitor Report published in June, 2008, protein therapeutics represents the second largest segment in pharmaceutical drug discovery. Since 2000, more than 25% of all new drugs approved have been biopharmaceuticals but there development is a time-consuming and costly endeavor. The development of biopharmaceuticals requires that the protein therapeutic is highly soluble since a substantial amount of the protein must be injected in patients via a small volume of solution. Pharmaceutical and biotechnology companies devote significant time and resources developing suitable formulations that allow the desired protein to be concentrated to high levels without inducing instability in the protein. This process of formulation development is often the major bottleneck in the protein therapeutic discovery process. This proposal involves the use of existing technologies and a novel high-throughput technology to provide information regarding a protein's solubility and stability in different solution conditions (formulations). The information will be used to train an artificial neural network program to predict totally new solution conditions that provide improved protein solubility and stability. If successful, this capability will accelerate and improve the ability to develop clinically useful formulations for biopharmaceuticals being developed by pharmaceutical, biotechnology, government and academic communities. It will also benefit any protein expression research organization (expressing aqueous or membrane proteins) that desires improved solubility and physical stability of expressed protein. It will reduce the cost and time required to develop new vaccines, monoclonal antibodies and other protein therapeutics. Soluble Therapeutics, LLC intends to support biopharmaceutical research as a CRO by establishing collaborative relationships with researchers from industry, academia and the government. It is expected that as industrial partners realize the advantages the company's novel technology it will lead to non-exclusive licenses and strategic partnerships. PUBLIC HEALTH RELEVANCE: This proposal involves the development and validation of a novel approach to improve and accelerate the discovery of biopharmaceuticals (i.e. vaccines, monoclonal antibodies and other therapeutic proteins). Biopharmaceuticals are used to treat a variety of infectious and chronic diseases. The proposed research is intended to establish a new paradigm for rapidly improving the solubility and physical stability of biopharmaceuticals. The paradigm will be evaluated using one or more vaccine candidates obtained from a pharmaceutical company as well as the protein osteoprotegerin (OPG), which is involved in bone mineralization and osteoporosis. According to the latest Data-Monitor Report published in June, 2008, protein therapeutics represents the second largest segment in pharmaceutical drug discovery. Since 2000, more than 25% of all new drugs approved have been biopharmaceuticals but there development is a time-consuming and costly endeavor. The development of biopharmaceuticals requires that the protein therapeutic is highly soluble since a substantial amount of the protein must be injected in patients via a small volume of solution. Pharmaceutical and biotechnology companies devote significant time and resources developing suitable formulations that allow the desired protein to be concentrated to high levels without inducing instability in the protein. This process of formulation development is often the major bottleneck in the protein therapeutic discovery process. This proposal involves the use of existing technologies and a novel high-throughput technology to provide information regarding a protein's solubility and stability in different solution conditions (formulations). If successful, this capability will accelerate and improve the ability to develop clinically useful formulations for biopharmaceuticals being developed by pharmaceutical, biotechnology, government and academic communities. Soluble Therapeutics, LLC intends to support biopharmaceutical research as via contract research by establishing collaborative relationships with researchers from industry, academia and the government. It is expected that as industrial partners realize the advantages the company's novel technology it will lead to non-exclusive licenses and strategic partnerships.