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

 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。 干细胞的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，干细胞市场的复合年增长率为24.2%，到2019年将达到约1195.2亿美元，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价格实惠的平台商业化，用于从混合种群中有效分离存活的单细胞或菌落，而无需从培养基中释放，这通常是对细胞有害的过程。该公司的“CellRaft”（以前的IsoRaft）技术是基于查佩尔山的北卡罗来纳州的Allbritton实验室开发的一种独特的细胞阵列。 核心技术包括用于培养细胞的一次性微阵列（CellRaft Array）和用于分离感兴趣的细胞/集落的简单手动操作仪器。 虽然许多商业上可获得的技术声称具有识别和选择特定细胞（如干细胞）的能力，但其局限性在于， 包括成本、需要大的样品尺寸、通过从培养物表面破坏细胞的分离进行收集以及用于鉴定感兴趣的细胞的限制性标准。 相比之下，CellRaft技术代表了一种快速、用户友好且经济实惠的细胞分离系统。 第一阶段的工作重点是为干细胞研究定制CellRaftTM系统。对一系列材料进行了评估，以掺入CellRaft中，从而产生具有优化的柔性、培养物相容性、表面粗糙度和几何形状（粗糙度）的消耗品。 方法也被标准化用于跟踪和收集单个CellRafts。 最后，将肠上皮干细胞（IESC）接种在CellRafts上，观察到基因表达与单细胞来源的IESC类肠细胞形态之间的新相关性。 这些数据最近发表在《自然细胞生物学》上，提供了强有力的概念证明，即干细胞生态位生物学可以用CellRaft系统复制和研究。 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分离和回收（AIR）系统，该系统包括具有适当光学和样品处理能力的仪器、自动信号分析软件以及CellRaft耗材的商业规模制造，然后CellRaft阵列原型系统将由Cell Microsystems进行内部验证，以及对干细胞生物学应用有各种兴趣的外部合作者。

 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.