SBIR Phase II: Resonant Sensors for Wireless Monitoring of Viable Cell Concentration in Small, Disposable Bioreactors

SBIR 第二阶段：用于无线监测小型一次性生物反应器中活细胞浓度的谐振传感器

• 批准号: 2025552
• 负责人: Samuel Rothstein
• 金额: $ 99.99万
• 依托单位: SKROOT LABORATORY INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2025552&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Resonant; Sensors

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the creation of a sensor system for cell-based manufacturing of such products as biologic therapies, food ingredients, and bio-based materials. These sensors will overcome current limitations for tracking critical cell growth data, which requires manual sampling with slow turnaround times. This system will enable better predictive growth models for improved production process development and will lead to better decision-making on cell type and culture conditions to produce biologic material. Better performance at this stage leads to potentially significant savings during the manufacturing lifetime of the drug.This Small Business Innovation Research (SBIR) Phase II project is focused on developing a wireless sensor system to address the need of continuously monitoring viable cell density during biomanufacturing. Many industries use cells for production, but the initial focus is upstream development of cell therapies and biologics. Central to this development is tracking the growth of cells in a variety of small-scale, single-use bioreactors to determine key event points for feed and harvest. Current methods rely on infrequent sampling and off-line counting due to the volume required, risk of contamination, and cost. The central research objective is to develop methods for standardized sensor and reader fabrication and quality testing for calibration studies in commercially-relevant environments and systems. The proposed project will develop: 1) sensor stickers that are applied to the exterior of culture vessels, 2) readers that interrogate the sensor, and 3) algorithms to convert the sensor signal to cell count and push notifications to operators.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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力是创建一种传感器系统，用于基于细胞的生物疗法，食品成分和基于生物的材料等产品的生产。这些传感器将克服跟踪关键细胞生长数据的当前局限性，这需要在速度缓慢的时间内进行手动采样。 该系统将为改善生产过程的发展提供更好的预测增长模型，并为细胞类型和培养条件提供更好的决策，从而产生生物学材料。在该药物的制造业生命周期内，在此阶段的表现更好。该小型企业创新研究（SBIR）II期项目着重于开发无线传感器系统，以满足在生物制造过程中不断监测可行的细胞密度的需求。许多行业使用细胞进行生产，但最初的重点是细胞疗法和生物制剂的上游发展。这种发展的核心是跟踪各种小规模的一次性生物反应器中细胞的生长，以确定饲料和收获的关键事件点。当前的方法依赖于由于所需的数量，污染的风险和成本而罕见的采样和离线计数。中心研究目标是开发用于标准化的传感器和读取器制造和质量测试的方法，以在商业上与之相关的环境和系统中的校准研究。 拟议的项目将开发：1）应用于培养容器外部的传感器贴纸，2）询问传感器的读者，以及3）算法将传感器信号转换为细胞计数并将通知转换给操作员。该奖项反映了NSF的奖项。法定任务，并被认为是值得通过基金会的智力优点和更广泛影响的审查标准来评估的值得支持的。