I-Corps: Commercialization of a Nanoparticle Concentration Apparatus

这个i-Corps团队展示了一种用于连续纳米颗粒浓缩的微型设备。制造这种装置的动机源于一个公认的挑战，即在资源有限的情况下制备生物纳米制品样品。生物纳米颗粒，如病毒、脂质体和外切体，经常被加工用于临床诊断、监测生物武器和大流行病原体、药物和食品安全以及药品制造，但它们通常只以非常稀薄的悬浮液存在。传统的方法如高速离心法和膜超滤法对生物纳米颗粒的浓缩是有效的，但这些间歇过程往往有不同的回收率，这取决于样品的组成、操作人员的技能和分离机制。这些常规方法还需要笨重的仪器、特殊的技能和较长的处理时间。最近流行的磁珠浓缩方法具有基础设施要求低的优点，但大多数生物物种需要亲和标记来施加足够的磁性，当目标浓度较低时，当存在抑制或竞争物种时，标记效率较低。该团队提出的微型设备通过在操作简单且不需要标记的便携式设备中连续浓缩生物纳米颗粒来解决上述挑战。它不同于目前在实验室中实践的昂贵设备和固定过程，是一种用于医疗保健点生物纳米粒子分析的使能技术。这样的设备有望影响许多领域，如制备病毒和外切体样本的诊断行业，以及用于纳米药物生产的制药行业。这里提出的微流控设备利用温度梯度和精心设计的对流来驱动纳米粒子的定向运动。通过将稀释的纳米颗粒样品流过微制造的流体通道，颗粒根据其固有的物理性质沿着轴向流动横向迁移，浓缩物物种从战略位置的出口被取回。这种设备的体积不超过一张名片，所有配件都可以微型化到手掌大小，使Bionanopple能够以低功耗在复杂的实验室之外进行浓缩。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格，这将指导设备未来的发展，朝着优先市场和客户方向发展。I-Corps计划还将使创业带头人和首席研究员掌握商业技能，并为他们进行技术翻译做好准备。

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.