This Small Business Technology Transfer (STTR) Phase I Project aims to optimize and test prototypes of continuous, multi-analyte sensors based on stimuli-responsive hydrogels. The proposed sensor array will be capable of monitoring multiple biomarkers relevant to several common human diseases such as diabetes, ketoacidosis, chronic obstructive pulmonary disease (COPD) and even obesity. During this project, the first generation wired sensors will be validated by long-term in vitro and in vivo (mice models) testing. Although the long-term (beyond current project) goal and final application of the device developed here-in will be in humans, in this project we will focus on developing a sensor targeting needs in animal research and the scientific community. This strategy creates a strong foundation and generates confidence in the sensor for clinical studies in few years. The proposed work will be accomplished within three subprojects: 1) Validation of long-term stability of hydrogel-based sensors in plasma, 2) Optimization of first generation wired implantable sensor array, 3) Long term validation of sensors in mouse models and basic histology studies. The team strongly believes they can accomplish these aims and build a product ready to serve the animal research and scientific community by the end of this project.
The broader impact/commercial potential of this project stems from the strong demand and an unmet need for continuous multi-analyte sensor in human and in animal-research market. Before attempting to enter the huge and difficult-to-penetrate human-market for continuous metabolic sensors the team will first generate revenue by providing devices for the more accessible animal market while continuously improving the sensor array. There are approximately 50 million research animals in the world. Assuming an average sales price of $250 per/sensor and the proposed technology addresses 1% of the total market, annual sales could exceed $100 million. This technology will provide researchers with a new tool to continuously monitor relevant biomarkers in a given animal over many days, which not only increases the efficiency of studying animal models but also supplies greater detail of their metabolism than is currently allowed by periodic sampling. A continuous monitoring system would save money, speed research, and provide greater insights into the pathogenesis and new potential therapies of diseases.
People worldwide depend on pharmaceutical drugs and therapeutics for better quality of life or extending the lifespan. Most drugs are expensive because of high manufacturing costs and it takes years of effort in research and development to launch new/better/novel drugs for different chronic diseases. This is primarily because of current manufacturing processes that are inefficient, bulky and present serious risk of contamination to production. Single-use technologies are revolutionizing the drug development and manufacturing process to yield faster lab-to-market drugs by enabling more efficient and reliable pharma manufacturing. Single-use bioreactors (SUBs) are replacing stainless bioreactors because SUBs require less capital investment, and can be used to produce pharmaceuticals at lower cost with faster time to market. However, sensors designed for monitoring process conditions in SUBs have not yet been developed, and the unavailability of disposable sensors is limiting the growth of SUB use despite increasing demand. The results of this project will meet the market demand for disposable sensors. This will enable pharmaceuticals to be produced faster through lower cost, thereby increasing their availability to larger segments of the population. In addition, the successful project will advance scientific understanding of stimuli-responsive hydrogels for other sensing applications. During NSF STTR phase 1, Applied Biosensors along with its collaborators at the University of Utah has developed a sensing technology based on smart polymers. This sensing technology is applicable to multiple markets such as bioprocess control, animal research market, water quality management, human disease management, etc. The major goal of this project was to develop a biosensing technology based on smart polymers that can monitor specific biomarkers such as Glucose, pH, Osmolarity, etc. Phase I research involved the synthesis and evaluation of novel stimuli-responsive polymers intended for use as the sensing elements of disposable sensors in single use bioreactors (SUBs). Our sensing system will have significant advantages over the other systems in the market such as Cost: ½ the cost of optical systems and significantly cheaper than manual measurements Multiple biochemical monitoring on single sensor/platform Gamma sterilization compatible (as desired by industry) Wireless data transmission Fast response (< 180 seconds) in wide range of chemical concentrations In short: a smaller, faster, better and significantly less expensive monitoring system.
