权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

A Novel 3-D System for Cost-Effective Industrial Production of Pluripotent Cells

用于经济高效地工业生产多能细胞的新型 3D 系统

基本信息

批准号：
8454262
负责人：
Bradley H. Garcia
金额：
$ 56.57万
依托单位：
PRIMORIGEN BIOSCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-04-01 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8454262
关键词：
3-Dimensional Address Adhesions Biological Products Bioreactors Cardiac Myocytes Cell Culture Techniques Cell Proliferation Cells Clinical Communication Consumption Cryopreservation Development Drug Formulations Endoderm Ensure Evaluation Freeze Drying Funding Future Goals Government Hematopoietic Hepatocyte Industrialization Industry Investigation Laboratory culture Marketing Methods Nutrient Oxygen Persons Pharmaceutical Preparations Pharmacologic Substance Phase Pluripotent Stem Cells Preclinical Drug Evaluation Process Production Proteins Recovery Research Running Shipping Ships Small Business Innovation Research Grant Solutions Source Stem cells Supplementation Suspension Culture Suspension substance Suspensions System Technology Testing Therapeutic Toxic effect Vitronectin Wood material Work Xeno Xenobiotics abstracting base cell type clinical application cost cost effective density drug discovery induced pluripotent stem cell large scale production neurodevelopment novel phase 1 study phase 2 study pluripotency public health relevance relating to nervous system scale up screening stem two-dimensional

项目摘要

DESCRIPTION (provided by applicant): Primorigen Biosciences (R) Abstract Primorigen Biosciences will use Phase II SBIR funds to advance its novel, 3-dimensional system for robust expansion of induced pluripotent stem cells (iPSCs) by a) scaling up iPSC production in 3L bioreactors, b) validating the bioreactor-expanded iPSCs for differentiatation into lineages of value for pharmaceutical drug screening, and c) validating large-scale cryopreservation of the iPSCs. Phase I studies successfully demonstrated feasibility of iPSC expansion in the new system, with the added benefits of substantially lowering media and labor requirements versus standard 2-dimensional culture. Phase II studies will validate the system for larger scale applications as described above. The ultimate commercial goals are to enable industrialization of stem cells and their derivatives by addressing the current technical and market need for cost-effective large scale production of pluripotent stem cells, a key barrier to the use stem cells for widespread drug screening and clinical therapeutics. To ensure utility for both applications, Phase II studies will continue the work initiated in Phase I to make the system xeno-free and adapatable for ultimate GMP production. The initial production applications will be targeted to companies requiring large quantities of phenotypically relevant cell types for drug discovery. Longer term, the system's paradigm-changing efficiency and scalability will be adapted to produce clinical-grade therapeutic cells derived from stem-cells.

描述（由申请人提供）： Primorigen Biosciences (R) 摘要 Primorigen Biosciences 将利用 II 期 SBIR 资金推进其新颖的 3 维系统，通过 a) 扩大 3L 生物反应器中 iPSC 的产量，b) 验证生物反应器扩增的 iPSC 分化为有价值的谱系，从而实现诱导多能干细胞 (iPSC) 的稳健扩增。药物筛选，以及 c) 验证 iPSC 的大规模冷冻保存。第一阶段研究成功证明了 iPSC 在新系统中扩展的可行性，与标准二维培养相比，具有大幅降低培养基和劳动力要求的额外优势。第二阶段研究将验证该系统是否适用于如上所述的更大规模应用。最终的商业目标是通过解决当前对具有成本效益的大规模生产多能干细胞的技术和市场需求，实现干细胞及其衍生物的工业化，这是使用干细胞进行治疗的一个关键障碍。广泛的药物筛选和临床治疗。为了确保这两种应用的实用性，第二阶段研究将继续第一阶段启动的工作，以使系统不含异种物质并适用于最终的 GMP 生产。最初的生产应用将针对需要大量表型相关细胞类型进行药物发现的公司。从长远来看，该系统的范式改变效率和可扩展性将适应生产来自干细胞的临床级治疗细胞。