SBIR Phase II: Improving silicon nanowire biosensors: throughput, repeatability, and quantifying measurement advantages

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是进一步开发用于生物制造的改进的生物传感。改进的生物传感技术将使生物制造商能够更好地测量其产品的纯度，从而开发出更纯净的产品。具体而言，该第二阶段项目是开发一种硅纳米线生物传感器，从概念验证到适用于生物制药生产中宿主细胞蛋白检测的初始测试和部署的工作平台。本项目开发的改良型生物传感器有望通过更高纯度和更安全的生物制药提高产量、降低成本并改善患者治疗效果。拟议项目将验证传感器的用途、功能和测量精度，并与当前的检测和测量方法进行比较。该创新是一种低成本的定量生物传感器，可以在同一芯片上检测许多不同的蛋白质，即使蛋白质以低浓度水平存在也可以检测。 该公司将使用垂直排列的硅纳米线阵列，一种廉价的工艺来制造纳米线，以及一种消除电接触纳米线阵列困难的设备设计。该公司将充分表征传感器的响应，并将此响应与当前行业中使用的指标进行比较。 为了实现这一目标，他们将增加制造这些传感器所需的工艺生产量，设置制造控制以实现传感器中可接受的一致性，测量这些传感器在宽范围的蛋白质浓度值上的响应，该奖项反映了NSF的法定使命，并被认为值得支持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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to further develop improved biosensing for biomanufacturing. Improved biosensing will enable biomanufacturers to better measure the purity of their products and thus develop processes that result in more pure products. Specifically, this phase II project is to develop a silicon nanowire biosensor from proof of concept to a working platform suitable for initial testing and deployment for the detection of host cell proteins in biopharmaceutical manufacturing. An improved biosensor developed in this project promises to improve yields, reduce costs, and improve patient outcomes through higher purity and safer biopharmaceuticals.The proposed project will validate the sensor's use, function, and measurement accuracy in comparison to current methods for detection and measurement. The innovation is a low-cost, quantitative biosensor that can detect many different proteins on the same chip and do so even when the proteins are present at a low concentration level. The company will use vertically aligned silicon nanowire arrays, an inexpensive process to make nanowires, and a device design that eliminates the difficulties in electrically contacting nanowire arrays. The company will fully characterize the sensor's response and compare this response to the metrics that are currently used in the industry. In order to achieve this goal, they will increase the process throughput required to make these sensors, set manufacturing controls to achieve an acceptable consistency in the sensors, measure the response of these sensors over a wide range of protein concentration values, and build a validation package to assist customers in their implementation for using these sensors.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.