Microfluidic Bioreactor for High Throughput Hepatotoxicity Screening

用于高通量肝毒性筛选的微流控生物反应器

基本信息

批准号：
7595066
负责人：
Paul Ju-Sung Hung
金额：
$ 34.05万
依托单位：
CELLASIC CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-01 至 2011-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7595066
关键词：
Acetaminophen Adoption Aflatoxin B1 Albumins Amiodarone Animal Model Animals Architecture Award Benchmarking Biological Assay Bioreactors Biotechnology Cell Count Cells Clinical Trials Collaborations Complement 3a Consumption Critical Pathways Cyclophosphamide Data Data Analyses Development Devices Diclofenac Diffusion Dose Drug Compounding Drug Industry Drug toxicity Engineering Exhibits Family Funding Future Goals Hepatocyte Hepatotoxicity Hour Housing Human In Vitro Industry Injury Length Letters Liver Methods Microfluidics Modeling Molecular Bank Morphology NIH Program Announcements Output Perfusion Pharmacologic Substance Phase Physiological Preclinical Drug Evaluation Protocols documentation Reagent Reproducibility Research Robotics Running Savings Screening procedure Statistical Data Interpretation System Tamoxifen Technology Testing Time Tissues Toxicology Urea Work base cell type commercialization cost design high throughput screening improved in vivo instrumentation interest novel pre-clinical prototype response scale up tool

项目摘要

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.

描述（由申请人提供）：第二阶段提案的主要目的是将SBS标准格式的微流体生物反应器阵列商业化，用于在I期中开发的，用于在药物和生物技术行业中基于高吞吐量的基于生理细胞的筛查，并特别关注预测性肝毒性筛选，以备临界的序列，以使其成为一名井井有条的序言，以使其成为一名秩序，以使FDA在FDA中提供，以便于其序言。筛查工具以外的动物模型。该主张的价值是在使用更生理的体外人肝文化模型进行昂贵且耗时的人类临床试验之前，提高药物毒性的预测。第二阶段奖项将使我们能够优化生物反应器设计，并向制药公司对通过动物研究的药物化合物进行产品β测试，这些药物通过动物研究，但在人类临床试验期间仍会造成肝损伤。在计划公告PA-06-019分子库筛选仪器的计划公告下，更具体地说，第二阶段的提议将继续授予I期项目（1R43DK076325-01），更具体地，将SBS标准微富集型生物反应器的商业化筛选，以在临床效果上尤其是在临床上效果，尤其是在临床上提供更好的人类模型。该项目的成功完成将在高通量肝毒性筛查上为药品和生物技术行业提供更好，更具成本效益的平台。