SBIR Phase II: Magnetic Quantum Dots for Cell Separation and Characterization
SBIR 第二阶段:用于细胞分离和表征的磁性量子点
基本信息
- 批准号:1926986
- 负责人:
- 金额:$ 75万
- 依托单位:
- 依托单位国家:美国
- 项目类别:Standard Grant
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-15 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
The broader/commercial impact of this SBIR phase II project will develop magnetic and fluorescent reagents for the separation and analysis of cells from tissue samples stored in biobanks, central repositories for biological samples, including tissues, cells, blood, sera, and urine, and their associated patient data, used in research to identify new methods to diagnose and treat disease; this industry is currently $52 B/yr with a compound annual growth rate (CAGR) of 4.5%. Biobank samples typically consist of a mixture of pathologically normal and diseased cells and tissues, requiring separation. Sample quality is thus critical for biobanks. The cell separation market ($3.9 B/yr, CAGR 4.1%) is dominated by the flow cytometry segment ($3.1 B/yr, CAGR 3.6%); whereas magnetic cell separation is a growing market ($582 M/yr by 2020 CAGR of 6.4%). Most biobanks currently provide unpurified samples or samples purified via flow cytometry alone, with typical recoveries of 10% at purities of ~20%. This research will develop and commercialize reagents that combine magnetic separation with flow cytometry analysis for target cell purification from biobank tissue samples. In the company's Phase I research of cells in suspension, these reagents yielded ~100% recovery with purities 75%. This research will expand this technology to tissue homogenates with increased heterogeneity and viscosity, increasing purity of biobank samples and enhancing researcher ability to develop breakthrough medical technologies.This research will develop magnetic-fluorescent nanoparticle reagents for cell separation and subsequent flow cytometry analysis of heterogeneous clinical tissue samples from biobanks. Given the heterogeneous nature of biological specimens that may contain more normal than diseased components, purification technologies are critical to biobank operation. Based on the Phase I research, the company anticipates that this technology could increase recovery and purity to 75% (vs. 10-20% currently). This will be accomplished by: (1) developing an open magnetic separation system to reduce obstruction compared to existing commercial magnetic bead-packed columns; (2) optimization of reagent magnetic and fluorescent content to maximize cell separation and analysis signal while minimizing size and signal overlap with tissue autofluorescence; (3) protocol development for tissue homogenate analysis using commonly employed mechanical and enzymatic tissue digestion methods. This research will yield new tools for cell isolation from complex, viscous environments that will greatly enhance the utility of biobank samples in research and clinical investigations. Such improvements will also benefit applications with less rigorous engineering design requirements, including bio/pharma separations, bioprocessing (e.g., CAR T-cell therapy), and clinical diagnostics (e.g., circulating tumor cell recovery).This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
SBIR第二阶段项目的更广泛/商业影响将开发磁性和荧光试剂,用于从生物库储存的组织样本中分离和分析细胞,生物库是生物样本的中央储存库,包括组织、细胞、血液、血清和尿液及其相关的患者数据,用于研究确定诊断和治疗疾病的新方法;该行业目前的年产值为520 B,复合年增长率(CAGR)为4.5%。 生物库样本通常由病理正常和患病细胞和组织的混合物组成,需要分离。 因此,样本质量对生物库至关重要。细胞分离市场(3.9 B美元/年,复合年增长率4.1%)由流式细胞术细分市场(3.1 B美元/年,复合年增长率3.6%)主导;而磁性细胞分离是一个不断增长的市场(到2020年复合年增长率为6.4%,每年5.82亿美元)。大多数生物库目前提供未纯化的样品或仅通过流式细胞术纯化的样品,其典型回收率为10%,纯度为~ 20%。这项研究将开发和商业化的试剂,结合联合收割机磁分离与流式细胞术分析的目标细胞纯化从生物库组织样本。在该公司对悬浮细胞的I期研究中,这些试剂的回收率约为100%,纯度为75%。该研究将把这项技术扩展到异质性和粘度增加的组织匀浆,提高生物库样本的纯度,并增强研究人员开发突破性医疗技术的能力。该研究将开发用于细胞分离的磁性荧光纳米颗粒试剂,并随后对生物库中的异质性临床组织样本进行流式细胞术分析。 鉴于生物样本的异质性,可能包含更多的正常比患病的成分,纯化技术是至关重要的生物库操作。 根据第一阶段的研究,该公司预计这项技术可以将回收率和纯度提高到75%(目前为10-20%)。这将通过以下方式实现:(1)开发一种开放的磁性分离系统,以减少与现有商业磁珠填充柱相比的阻塞;(2)优化试剂磁性和荧光含量,以最大化细胞分离和分析信号,同时最小化尺寸和与组织自体荧光的信号重叠;(3)使用常用的机械和酶组织消化方法开发组织匀浆分析的方案。这项研究将产生新的工具,用于从复杂的粘性环境中分离细胞,这将大大提高生物库样本在研究和临床调查中的效用。这样的改进也将有利于工程设计要求不太严格的应用,包括生物/制药分离、生物处理(例如,CAR T细胞疗法)和临床诊断(例如,该奖项反映了NSF的法定使命,并通过使用基金会的知识价值和更广泛的影响审查标准进行评估,被认为值得支持。
项目成果
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