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）第二阶段项目的更广泛的影响/商业潜力是创建一个传感器系统，用于生物疗法，食品配料和生物基材料等产品的细胞制造。这些传感器将克服目前跟踪关键细胞生长数据的限制，这需要手动采样，周转时间很慢。 该系统将能够更好地预测生长模型，以改进生产工艺开发，并将导致更好地决策细胞类型和培养条件，以生产生物材料。这一阶段更好的性能可能会在药物的生产生命周期内节省大量资金。这一小型企业创新研究（SBIR）第二阶段项目的重点是开发一种无线传感器系统，以满足生物制造过程中持续监测活细胞密度的需求。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开发。这项开发的核心是跟踪各种小规模一次性生物反应器中细胞的生长，以确定进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的方法，用于商业相关环境和系统中的校准研究。 该项目将开发：1）贴在培养容器外部的传感器贴纸，2）询问传感器的读取器，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NSF的法定使命，并通过使用基金会的智力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.