Microfluidic Bioreactor for High Throughput Hepatotoxicity Screening

描述（由申请人提供）：第二阶段提案的主要目标是商业化第一阶段开发的SBS标准格式微流控生物反应器阵列，用于制药和生物技术行业的高通量生理细胞筛选，特别关注预测性肝毒性筛选，自2005年以来已被FDA列为关键路径倡议之一，以提供比动物模型更好的临床前药物筛选工具。这一主张的价值在于，在使用更具生理性的体外人肝培养模型进行昂贵且耗时的人体临床试验之前，可以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药物化合物的产品beta测试，这些药物化合物通过了动物研究，但在人体临床试验中仍会造成肝损伤。II期计划是继续项目公告PA-06-019 Molecular Libraries Screening Instrumentation下授予的I期项目（1R43DK076325-01），更具体地说，是将SBS标准微流控生物反应器阵列商业化，以便在临床试验中提供更好的体外人体模型来预测药物毒性作用，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、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.