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

这个小企业创新研究（SBIR）第一阶段项目是开发微流体生物芯片，用于从水中快速检测细菌微生物的活力，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（制药、食品和环境）进行的细菌测试超过5亿次，其中超过2亿次用于必须对水、缓冲介质和任何注射液体进行无菌的制药应用。70%以上的检测是利用传统菌落培养计数（2-7天）检测总活菌。一旦检测到任何活的微生物，进行更详细的遗传分析或免疫测定进行鉴定（另外5-10天）。这个第一阶段的项目将以普渡大学授权的技术为基础，开发其第一个产品的一部分，该产品将包含一个微流体芯片实验室。该芯片将使用介质电泳将细胞浓缩在水缓冲液中，并使用微尺度阻抗测量在不到3小时内从水样中电子检测微生物的活力。后续的第二阶段项目将开发完整的原型系统，可以在生物制药生产设施进行beta现场测试。该项目的初步商业应用将在生物制药行业。在食品加工、环境监测和国土安全领域的其他应用也被设想在未来。

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.