I-Corps: Commercialization of a Nanoparticle Concentration Apparatus

这个I-Corps团队提出了一种用于连续纳米颗粒浓缩的微型设备。创建这种装置的动机源于在资源有限的环境下制备生物纳米颗粒样品的公认挑战。生物纳米颗粒，如病毒，脂质体和外来体经常被加工用于临床诊断，生物武器和流行病病原体的监测，药物和食品安全以及药物的制造，但它们通常仅存在于非常稀的悬浮液中。虽然传统的方法，如高速离心和膜超滤，是有效的浓缩生物纳米粒子，这些批处理往往具有可变的回收率，这取决于样品组成，操作员的技能和分离机制。这些传统方法还需要庞大的仪器、特殊技能和长的处理时间。最近流行的使用磁珠的浓缩方法提供了基础设施要求低的优点，但是大多数生物物种需要亲和标记以施加足够的磁性，并且当靶浓度低时以及当存在抑制性或竞争性物种时，标记效率差。该团队提出的微型设备通过在便携式设备中连续浓缩生物纳米颗粒来解决上述挑战，操作简单，无需标记。它脱离了目前在实验室中实践的昂贵设备和固定过程，是一种用于即时生物纳米颗粒分析的技术。这种装置有望影响许多领域，例如用于制备病毒和外泌体样品的诊断行业，以及用于纳米药物生产的制药行业。这里介绍的微流体装置采用温度梯度和精心设计的对流来驱动纳米颗粒的定向运动。通过使稀释的纳米颗粒样品流过微制造的流体通道，基于颗粒的固有物理性质，颗粒沿轴向流沿着侧向迁移，并且从策略性放置的出口取回浓缩物。该设备的占地面积不超过名片，所有配件可缩小到手掌大小，该设备允许在复杂的实验室之外以小功耗进行生物纳米颗粒浓缩。I-Corp团队打算进行市场分析，并探索纳米颗粒浓缩器的商业化潜力。通过与不同工业部门的人员直接对话，将确定实践所需的关键规范，这将指导未来针对优先市场和客户的设备开发。I-Corps计划还将为企业领导和首席研究员提供商业技能，并为技术翻译做好准备。

This I-Corps team presents a microdevice for continuous nanoparticle concentration. Motivation to create such a device stems from a well-recognized challenge of preparing bionanoparticle samples at resource limited settings. Bionanoparticles, such as viruses, liposomes and exosomes are frequently processed for clinical diagnostics, surveillance of biological weapons and pandemic pathogens, drug and food safety, as well as manufacturing of medicines, but they usually are present only in very dilute suspensions. While the conventional methods, such as high-speed centrifugation and membrane ultrafiltration, are effective for concentrating biological nanoparticles, these batch processes often have variable recovery, dependent on the sample composition, operators' skills and the separation mechanism. These conventional methods also require bulky instruments, special skills and long processing time. The recently popularized concentration approach using magnetic beads offers an advantage of low infrastructure requirement, but most biological species require affinity labeling to impose sufficient magnetism, and the labeling efficiency is poor when the target concentration is low and when inhibiting or competitive species are present. The microdevice presented by this team addresses above challenges through continuous concentration of bionanoparticles in a portable device with simple operation and without the need of labeling. It departs from expensive devices and immobile processes that are currently practiced in laboratories, and is an enabling technology for point-of-care bionanoparticle analysis. Such a device is expected to impact many fields, such as the diagnostic industry for the preparation of virus and exosome samples, and the pharmaceutical industry for nanomedicine production.The microfluidic device presented here employs a temperature gradient and a carefully engineered convection to drive directional motion of nanoparticles. By flowing a dilute nanoparticle sample through a micro-fabricated fluid channel, the particles migrate sideways along the axial flow, based on their intrinsic physical properties, and the concentrate species are retrieved from a strategically placed outlet. With a device footprint no bigger than a business card and all accessories miniaturizable to palm-size, this device allows bionanoparticle concentration outside of sophisticated laboratories with small power consumption. The I-Corp team intends to perform market analysis and explore commercialization potential for the nanoparticle concentrator. Through direct conversation with people at different industrial sectors, key specifications needed for practice will be identified, which will guide future development of device towards prioritized markets and customers. The I-Corps program will also equip the entrepreneurial lead and the principal investigator with business skills and prepare them for technology translation.