This Small Business Innovation Research (SBIR) Phase I project is to develop micro-fluidic biochips for the rapid viability detection of bacterial microorganisms from water, specifically for the pharmaceutical and bio-pharmaceutical manufacturing applications. There are over 500 million bacterial tests performed in the industrial microbiological control market (pharmaceutical, food and environment) every year and over 200 million of those are for pharmaceutical applications where sterility of water, buffer media, and any injectable fluids is a necessity. Over 70 percent of these tests performed are for the detection of total viable microorganisms using traditional colony culture count (2-7 days). Once any viable microorganisms are detected, more detailed genetic analysis or immunoassays are performed for identification (another 5-10 days). This Phase I project will build on technology licensed from Purdue University to develop part of its first product which will incorporate a micro-fluidic lab-on-a-chip. This chip will use dielectrophoresis to concentrate cells in an aqueous buffer, and micro-scale impedance measurements to electronically detect the viability of microorganisms from water samples in less than 3 hours. The follow-on Phase II project will develop the complete prototype system that could be beta-site tested at biopharmaceutical manufacturing facilities. The initial commercial application of this project will be in the bio-pharmaceutical industry. Additional applications in the areas of food processing, environmental monitoring and homeland security are also envisioned in the future
