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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是为生物疗法、食品配料和生物基材料等产品的细胞制造创造一个传感器系统。这些传感器将克服当前跟踪关键细胞生长数据的限制，这些数据需要人工采样，周转时间较慢。该系统将为改进生产过程开发提供更好的预测生长模型，并将对生产生物材料的细胞类型和培养条件做出更好的决策。在这一阶段，更好的性能可以在药物的生产周期内潜在地节省大量费用。这个小型企业创新研究（SBIR）二期项目的重点是开发一种无线传感器系统，以解决生物制造过程中持续监测活细胞密度的需求。许多行业都使用细胞进行生产，但最初的重点是细胞疗法和生物制剂的上游开发。这一发展的核心是在各种小规模、一次性生物反应器中跟踪细胞的生长，以确定饲料和收获的关键事件点。由于所需的体积、污染风险和成本，目前的方法依赖于不频繁的采样和离线计数。中心研究目标是开发标准化传感器和读取器制造和质量测试方法，用于商业相关环境和系统的校准研究。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)询问传感器的读取器，以及3)将传感器信号转换为细胞计数并向操作员推送通知的算法。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 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.