SBIR Phase I: Medical Device to Isolate and Purify Therapeutic Antibodies from Recovered Donors (COVID-19)

这个小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力在于管理致病性暴发。该项目将以一种新颖而安全的方式从康复患者的血液中纯化治疗性抗体，用于其他危重患者的治疗。这项技术甚至可以在病毒发生突变时使用。基于这项技术的设备将是便携式的，可以轻松快速地部署到偏远地区拯救生命。这是一种平台技术，不仅可用于潜在的COVID-19治疗，还可用于未来的致病性暴发或为各种毒药提供解毒剂。拟议的项目将解决用于COVID-19治疗的恢复期血清相关问题。由于对捐赠者和接受者都存在潜在风险，这种方法并未被广泛用作第一道防线。此外，一个捐献者只能提供有限数量的恢复期血清来治疗一个接受者。目前还没有办法直接从全血中分离免疫球蛋白，并从单个供体中产生多剂量的免疫球蛋白。关键的挑战之一是开发一种合适的磁层析介质，该介质涂有蛋白a，具有顺磁性，对免疫球蛋白具有高结合能力。该项目将使用核心顺磁粒子生成介质。培养基将用于兔血和人血的研究，以评估其适用性。将开发一个原型分离室，用于从其他材料中分离磁珠。该项目还将探索一次性使用组件和自动化操作的系统工程。该奖项反映了美国国家科学基金会的法定使命，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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in managing pathogenic outbreaks. This project will purify therapeutic antibodies from recovered patients’ blood for therapeutic use in other critically ill patients in a novel and safe process. This technology can be used even as viral mutation takes place. The device based on this technology will be portable and can be deployed easily and swiftly to remote areas to save lives. This is a platform technology and will not only be useful as a potential COVID-19 treatment but also for future pathogenic outbreaks or to give antidotes for various poisons. The proposed project will address issues associated with convalescent sera used for COVID-19 treatment. This approach is not widely used as the first line of defense due to potential risks for both donors and recipients. In addition, one donor can provide only a limited amount of convalescent sera to treat only one recipient. Currently no methods exist to isolate immunoglobulins directly from whole blood and generate multiple doses from a single donor. One of the key challenges is the development of a suitable magnetic chromatography media that is coated with Protein A, has paramagnetic properties, and high binding capacity for immunoglobulins. This project will generate media using core paramagnetic particles. Media will be used to perform studies with rabbit and human blood to assess its suitability. A prototype separation chamber will be developed for separation of magnetic beads from other materials. This project will also explore systems engineering for single-use disposable components and automated operation.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.