The CellRaft AIR System: Workflow Automation for Stem Cell Isolation and Recovery

 描述(由申请人提供)：干细胞研究是一个新兴领域，有望为疾病治疗和药物发现创造引人注目的新方法。干细胞研究和再生医学市场空间是当今生命科学行业最具活力的领域之一。在全球范围内，干细胞市场正以24.2%的复合年增长率增长，到2019年将达到约11952亿美元的规模，而技术进步被认为是推动该领域增长的关键因素之一。细胞微系统公司是一家总部位于北卡罗来纳州的初创生物技术公司，其使命是将一种新颖但负担得起的平台商业化，用于有效地从混合种群中分离出可存活的单细胞或菌落，而不需要从培养底物中释放，这往往是对细胞有害的过程。该公司的“CellRaft”(前身为IsoRaft)技术基于北卡罗来纳大学(UNC)教堂山分校Allbritton实验室开发的独特细胞阵列。核心技术包括用于培养细胞的一次性微阵列(CellRaft阵列)和用于分离感兴趣的细胞/菌落的简单、手动操作的仪器。虽然许多商业上可用的技术声称能够识别和选择特定的细胞，如干细胞，但限制 仍然存在，包括成本、对大样本大小的需要、通过破坏细胞的培养表面分离进行采集，以及识别感兴趣细胞的限制性标准。相比之下，CellRaft技术代表了一种快速、用户友好和负担得起的细胞分离系统。第一阶段的工作重点是为干细胞研究量身定做CellRaft(Tm)系统。对一系列材料进行了评估，以将其整合到CellRaft中，从而产生了具有优化的灵活性、文化兼容性、表面粗糙度和几何形状(凹陷)的消耗品。跟踪和收集单个CellRafts的方法也是标准化的。最后，将肠上皮干细胞(IESCs)种植在CellRafts上，观察到单个细胞来源的IESC肠样体的基因表达和形态之间的新的相关性。最近发表在《自然细胞生物学》上的这些数据提供了强有力的证据，证明了干细胞-细胞-利基生物学可以利用CellRaft系统进行复制和研究。为了扩大这些研究并启动这一强大系统的商业化，第二阶段将专注于开发自动隔离和回收(AIR)系统，其中包括具有适当光学和样本处理能力的仪器、自动化信号分析软件以及CellRaft消耗品的商业规模制造，然后CellRaft阵列原型系统将由Cell MicroSystems以及对干细胞生物学应用感兴趣的外部合作者进行内部验证。

 DESCRIPTION (provided by applicant): Stem cell research is an emerging field with the promise of creating dramatic new approaches for disease treatment and drug discovery. The research and regenerative medicine market space for stem cells is one of the most dynamic areas in the life science industry today. Globally, the stem cell market is growing at a CAGR of 24.2% and will reach an approximate value of US$119.52 billion by 2019, and technological advancement is believed to be one of the key factors that will drive growth in this field. Cell Microsystems is North Carolina-based start-­‐‑up biotechnology company whose mission is to commercialize a novel, yet affordable, platform for the efficient isolation of viable, single cellsor colonies from a mixed population without the need for release from the culture substrate, an often times detrimental procedure to the cell. The company's "CellRaft" (formerly IsoRaft) technology is based on a unique cell array developed by the Allbritton Laboratory at the University of North Carolina (UNC) at Chapel Hill. The core technology comprises a disposable microarray (the CellRaft Array) for culturing cells and a simple, manually operated instrument for isolating the cell/colony of interest. While a number of commercially available technologies claim capabilities toward identifying and selecting specific cells, such as stem cells, limitations remain, including cost, a need for large sample sizes, collection via cell-damaging detachment from the culture surface, and restrictive criteria for identifying cells of interest. In contrast,the CellRaft technology represents a rapid, user-friendly, and affordable cell isolation system. Phase I efforts focused on tailoring theCellRaft(tm) System for stem cell research. A range of materials were evaluated for incorporation into the CellRaft resulting in a consumable with optimized flexibility, culture compatibility, surface roughness and geometry (concavity). Methods were also standardized for the tracking and collection of single CellRafts. Finally, intestinal epithelial stem cells (IESCs) were seeded on CellRafts, with novel correlations observed between gene expression and morphology of single cell-­‐‑derived IESC enteroids. These data, recently published in Nature Cell Biology, provide strong proof of concept that stem-‑cell‑niche biology can be replicated and studied with the CellRaft System. To expand these studies and initiate commercialization of this powerful system, Phase II will focus on development of an Automated Isolation and Recovery (AIR) System comprising an instrument with appropriate optics and sample handling capabilities, automated signal analysis software, and commercial scale manufacturing of the CellRaft consumable, the CellRaft Array Prototype systems will then be validated internally by Cell Microsystems, as well as by external collaborators with various interests in stem-cell biology applications.