Microfluidic Bioreactor for High Throughput Hepatotoxicity Screening

描述（申请人提供）：第二阶段提案的主要目标是将第一阶段开发的SBS标准格式微流体生物反应器阵列商业化，用于制药和生物技术行业中基于生理细胞的高通量筛选，特别关注预测性肝毒性筛选，自2005年以来，FDA已将其列为关键路径计划之一，以提供除动物模型外更好的临床前药物筛选工具。这一主张的价值在于，在昂贵且耗时的人体临床试验之前，使用更符合生理学的体外人肝培养模型来改善药物毒性的预测。第二阶段的奖励将使我们能够优化生物反应器的设计，并启动与制药公司的产品测试，对药物化合物，通过动物研究，但仍然在人体临床试验中造成肝损伤。II期提案是根据计划公告PA-06-019分子库筛选仪器继续授予的I期项目（1 R43 DK 076325 -01），更具体地说，是将SBS标准微流体生物反应器阵列商业化，以提供更好的体外人体模型，预测临床试验期间的药物毒性效应，特别是肝毒性。该项目的成功完成将为制药和生物技术行业提供一个更好和更具成本效益的高通量肝毒性筛选平台。

DESCRIPTION (provided by applicant): The main objective of the Phase II proposal is to commercialize the SBS standard format microfluidic bioreactor array developed in Phase I for high throughput physiologic cell-based screening in the pharmaceutical and biotechnology industry, with special focus on predictive hepatotoxicity screening, which has been included as one of the Critical Path Initiatives by the FDA since 2005 in order to provide better pre-clinical drug screening tools other than animal models. The value of this proposition is to improve prediction of drug toxicity before the expensive and time consuming human clinical trials using a more physiological in vitro human liver culture model. The Phase II award will enable us to optimize the bioreactor design and initiate the product beta testing with pharmaceutical companies on drug compounds that passed animal studies yet still caused liver injuries during human clinical trials. The Phase II proposal is to continue the awarded Phase I project (1R43DK076325-01) under program announcement PA-06-019 Molecular Libraries Screening Instrumentation , more specifically, to the commercialization of an SBS standard microfluidic bioreactor array to provide a better in vitro human model to predict drug toxicity effect during clinical trials, especially liver toxicity. The successful completion of the project will provide the pharmaceutical and biotechnology industry a better and more cost-effective platform on high throughput liver toxicity screening.