SBIR Phase I: Rapid Detection of Bacterial Contaminants Using Micro-fluidic Biochips

这个小型企业创新研究(SBIR)第一阶段的项目是开发微流控生物芯片，用于快速检测水中细菌微生物的活性，特别是用于制药和生物制药制造应用。每年在工业微生物控制市场(药品、食品和环境)进行的细菌测试超过5亿次，其中超过2亿次用于需要水、缓冲介质和任何可注射液体无菌的制药应用。其中70%以上的测试是使用传统的菌落培养计数(2-7天)来检测总的活微生物。一旦检测到任何活的微生物，就会进行更详细的遗传分析或免疫分析以进行鉴定(再过5-10天)。这个第一阶段的项目将建立在普渡大学授权的技术基础上，以开发其第一个产品的一部分，该产品将结合微流控芯片实验室。这种芯片将使用介电技术在含水缓冲液中浓缩细胞，并使用微型阻抗测量在不到3小时的时间内从水样中电子检测微生物的生存能力。后续的第二阶段项目将开发完整的原型系统，可以在生物制药制造厂进行现场测试。该项目的初步商业应用将在生物制药行业。未来还将在食品加工、环境监测和国土安全领域进行更多的应用。

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.