Research Project
9341643
Project Summary There is a critical gap between the need to evaluate the effect of chemicals on human physiology and the availability of in vivo and in vitro testing systems that provide the necessary predictive data. This need is especially pronounced for corrosive and caustic chemicals that are not compatible with current in vitro and in vivo testing systems. For example, the Toxic Substances Control Act (TSCA) requires that the EPA inventory all currently manufactured, processed, and imported chemical compounds. This list currently contains 85,000 chemicals, many with no toxicity data evaluated in a biologically relevant manner. The scope of this SBIR project is to develop a first-in-class corrosive resistant fluidic culture system that will enable industries, including environmental, regulatory, agricultural, chemical and consumer products, to evaluate thousands of corrosive and caustic chemicals for their effects on human tissues and cell lines, under physiologically relevant conditions. SciKon, Inc has previously introduced a disruptive technology to the scientific tools market that enables toxicity testing under non-linear flow conditions in a microfluidic environment. The corrosive resistant SciFlow system to be developed in this work will provide three major advances over current toxicological testing options: 1) dramatically improved biological relevance due to the fluidic and non-linear exposure gradients of the core SciFlow technology; 2) ability to test corrosive chemicals at higher doses for longer periods of time without degradation of the tissue culture plate and exposure of the cells to the plastic breakdown products; 3) compatibility with high content imagers and plate readers due to the optical properties of the glass-like plastic polymers and SBS compliant plate format. In Phase I, we will complete the following Specific Aims: Aim 1: Characterize glass-like polymers that can withstand corrosive environments, are able to be injection molded for mass production, and are inert for cell culture. Aim 2: Generate a glass-like SciFlowTM System prototype for corrosive exposure kinetics and bioassay evaluation. Upon completion of the Phase I aims, our Phase II work will focus on validating the system and scaling the unit for production. Successful completion of this project will result in development of the SciFlow corrosive-resistant system, which will provide the first in vitro system with a chemically inert environment suitable for repeated dosing in long-term corrosive culture environments.
