Researchers have developed a new in vitro instrument. The device allows cultured living cells to be exposed to complex air pollution mixtures of gases and particles directly, without pre-collection or conditioning. Previous work has found that conditioning results in underestimation of exposure risk. This device provides faster exposure times, is less expensive, and is more sensitive at lower exposure concentrations. Cells in the device are exposed to a realistic pollution mixture, similar to what a human experiences. This technology has the potential to provide information for gaps in our scientific knowledge concerning the full impact of air pollution on public health. These gaps include the identification of the pollutants responsible for health effects, the synergistic effects of mixtures of multiple pollutants, and how to efficiently and affordably monitor all pollutants in real time.
This device fills a "missing technology" that can accurately perform in vitro exposures without errors. It is a multi-use platform that can sample any type of air and expose any type of living cell. It has applications with assessment of the toxicity of any breathable space, testing inhaled therapeutic drugs, cosmetics, product safety, occupational safety, and bioterrorism detection. The initial focus will be on airborne toxins as there is no marketed instrument that fulfills the need for comprehensive in vitro analysis of chemistry and biology.
Report Type: General Public Project Report PI: Kenneth Sexton The lead product under development is an instrument (www.quantaire.com) designed for laboratory use by researchers in toxicology, including academic (there are over 1,000 departments of toxicology, environment, and public health in the US), government (EPA, NIOSH, NIEHS, etc.), and chemistry-based industrial facilities. This will help satisfy a demand for toxicology and epidemiology studies using real-world samples and exposures. For example, there is a mandate from the EPA to conduct toxicology studies in future epidemiology air pollution studies. This is limited by suitable methods, and our instrument helps satisfy this need. Currently, the potential customer is using sampling methods that distort the true characteristics of pollutants. Research has proven that these methods are inadequate and provide erroneous results including non-linear and inverse dose response curves. Currently potential customers are purchasing instruments having the basic features of our instrument, but these are only useful for high concentration pollutant mixtures such as cigarette smoke, or require the use of pre-concentration methods that distort and modify the composition and characteristics of the pollutants. Further, these devices have a limited number of tissue samples that can be exposed and thus suffer from low statistical power. There is great demand for a more sensitive instrument with better performance and characteristics that mimics true human deposition in the airway. Future customers may also include pharmaceutical companies for testing dose response and safety of new drugs for inhaled delivery. The technology is also suitable for targeting the emerging field of nanoparticles and to address the high level of concern over their safety. Smoking tobacco remains a serious health risk, but remains a significant product globally (US$>600 billion) and new tobacco-based products are being introduced daily. Safety of these new products may provide another use of the technology. We also foresee a service business for customers who seek turnkey experiments to test and analyze air streams of interest to their missions, coupling chemical analysis with biological outcomes. Results Business Development Thanks to the resources provided in this program we were able to meet and discuss our value proposition with potential customers. We conducted 86 interviews with potential customers, partners, or anyone interested in our instrument. These valuable interactions helped narrow down our first customer segment and define the minimum viable product that would suit their needs. These interactions also sharpened our value proposition and resulted in a rich database of contacts and meeting notes. The work completed for this grant produced several important products. The first is the detailed contact database and notes collected from our interviews. These have been archived and will continue be updated providing a valuable resource for the company. The second product was our canvas shown in Figure 1, which shows our value proposition and other important business development decisions. We continue to use this for our strategic planning. The production of this canvas would not have been possible without the resources provided by the NSF workshops and the large number of interviews conducted. We have also produced a video describing our company. This video is available for download[1]. [1]https://dl.dropboxusercontent.com/u/51144099/21%20Biodeptronics%202minICorps_Final.mp4 Using the information from this grant we applied for a NSF SBIR award. The materials collected in this grant were useful in developing the commercial sections of the application. The product proposed in the SBIR was a transportable instrument for use in both indoor and outdoor settings for the study of atmospheres containing engineered nanoparticles (ENP). The compactness and low weight of the instrument would be highly valuable for easy movement to and within a variety of laboratory and other indoor sites, e.g., manufacturing spaces. The ENPs of interest may be purposefully generated for research or present in ambient air from: inadvertent consequences of manufacturing processes, commercial products containing ENPs (they may release them over time), or from ENPs escaping from materials being processed as waste. Such release of ENPs into various atmospheres is an important, but very understudied area that must be better understood for potential toxicological impact. The broad commercial marketplace for the proposed instrument is comprised of academic, government, and commercial entities that perform in vitro toxicology on ENPs. The proposed instrument from the SBIR would satisfy a significant portion of the present and growing demand for an easy-to-use, self-contained, transportable instrument for in vitro toxicology studies on ENPs using real-world air samples and exposures as in-life.
