STTR Phase II: Development of Bio-compatible and Bio-safe Cell Sorters

小企业技术转移（STTR）第二阶段项目的更广泛/商业影响将是细胞分选器，这是一种用于生命科学研究、动物繁殖和细胞治疗的新研究工具。在过去的十年中，细胞分选器在分子和细胞生物学、免疫学、植物生物学、动物繁殖以及医学诊断和治疗等许多领域发挥了至关重要的作用。尽管它们具有重要的影响，但目前的细胞分选器存在以下缺点：设备和维护成本高，生物安全问题严重，细胞活力和功能降低。这些缺点降低了细胞分选器在许多重要研究和临床应用中的有效性。通过这项创新，研究人员将能够更好地了解疾病的原因，确定新的治疗方法，并测试新的药物和疫苗。它还具有提高乳制品生产效率的潜力，并帮助医生在诊断和治疗方面做出更好的决定。在第二阶段，目标是提高仪器的性能，并与最终用户验证性能。这个STTR二期项目将展示一种基于微流体的、生物兼容的、生物安全的、荧光激活的细胞分选器的可行性。细胞分选器是功能强大、高通量、单细胞表征和纯化工具，对于分子生物学、病理学、植物生物学、干细胞生物学和医学诊断等领域的实验室至关重要。该技术基于声流体（即声学和微流体的融合）细胞分选芯片，可以保持被分选细胞的完整性和功能。由于高剪切应力、高冲击力和高驱动电压，当前的细胞分选系统降低了细胞活力、完整性和细胞功能，降低了它们作为研究工具和临床应用的有效性。与目前使用静电力对细胞进行分选（需要12,000 V的驱动电压）不同，该技术使用声学镊子对细胞进行分选，只需要10 V的驱动电压，大大减少了细胞损伤。与现有的细胞分选器相比，所提出的微流控细胞分选器具有以下优点：1)生物相容性高；2)生物安全性高；3)成本更低，维护成本更低。此外，细胞分选器将更便于研究人员使用，并解决市场上现有的未满足需求（例如，在保持高活力和功能的同时分选脆弱或敏感的细胞）。这将加速研究成果，改善诊断和治疗方法。

The broader/commercial impact of the Small Business Technology Transfer (STTR) Phase II project will be a cell sorter, a new research tool for life science research, animal reproduction, and cell-based therapy. In the past decade, cell sorters have become vital in many fields, such as molecular and cellular biology, immunology, plant biology, animal reproduction, and medical diagnostics and therapeutics. Despite their significant impact, current cell sorters have the following drawbacks: high equipment and maintenance costs, significant bio-safety concerns, and reduced cell viability and function. These drawbacks reduce the effectiveness of cell sorters in many important research studies and clinical applications. Enabled by this innovation, researchers will be able to better understand the causes of diseases, identify new therapies, and test new drugs and vaccines. It also has the potential to improve dairy production efficiency, and aid medical doctors in making better decisions about diagnosis and treatment. In Phase II, the goal is to improve performance of the instrument, and validate the performance with end users.This STTR Phase II project will demonstrate the feasibility of a microfluidic-based, bio-compatible, bio-safe, fluorescence-activated cell sorter. Cell sorters are powerful, high-throughput, single-cell characterization and purification tools that are vital for labs in fields such as molecular biology, pathology, plant biology, stem cell biology, and medical diagnostics. The technology is based on acoustofluidic (i.e., the fusion of acoustics and microfluidics) cell sorting chips that preserve the integrity and functionality of sorted cells. Current cell sorting systems reduce cell viability, integrity, and cell function due to high shear stress, high impact force, and high driving voltage, which reduces their effectiveness as a research tool, and in clinical applications. Unlike current cell sorters that use electrostatic force to sort cells, which require 12,000 V of driving voltage, the proposed technology uses acoustic tweezers to sort cells, and requires only 10 V, which significantly reduces cell damage. Compared with existing cell sorters, the proposed microfluidic cell sorter will have the following advantages: 1) high bio-compatibility; 2) high bio-safety; and 3) lower costs and lower maintenance. In addition, the cell sorter will be more accessible to researchers and address existing unmet needs in the market (e.g., sorting fragile or sensitive cells while preserving high viability and function). This will accelerate research findings and improve diagnostics and therapeutics.