SBIR Phase I: High-throughput injectability screening of high concentration protein formulations by multiplexed microfluidic quartz resonators

SBIR 第一阶段：通过多重微流控石英谐振器对高浓度蛋白质制剂进行高通量可注射性筛选

• 批准号: 2025974
• 负责人: Zehra Parlak
• 金额: $ 25.57万
• 依托单位: Qatch Technologies LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2025974&HistoricalAwards=false
• 关键词: SBIR; Phase; throughput; injectability; screening

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project advances a new type of drug delivery. Protein-based drugs (biologics) have become more popular due to their high specificity of activity and generally low level of side effects. Biologics treat many conditions, impact lives of millions of patients, and have a global revenue of over $100 B. Patients prefer and comply with injectable versions of biologics because injections are rapid and make home-administration possible, unlike IV infusions that require clinic visits lasting several hours. However, the development and utility of many biologics is hampered by their inability to be used via injections because they are thick liquids. The technology developed in this project will act as an early-stage screening to determined the suitability of potential drug formulation for injection, enabling delivery of new drugs.This SBIR Phase I project will increase the number of injectable protein-based therapeutics by providing early screening of protein formulation viscosity. Viscosity measurements early in formulation development are currently not possible because the existing viscometers require high material volumes. Therefore, injectability of new protein-based formulations cannot be tested until significant amounts of material are developed, typically at late stages of preclinical research. This project will create a high-throughput viscometer that requires only drops for each test, for formulation optimization; it will determine the feasibility of multiplexing microfluidic quartz sensors on the same substrate to achieve simultaneous viscosity measurements. Specifically, in this project, 1) the electronics for the multiplexed sensors will be developed, 2) the multiplexed sensors will be designed using analytical and finite element models, and 3) these designs will be executed by microfabrication. Finally, the multiplexed microfluidic quartz sensors will be tested by analyzing relevant formulations simultaneously.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）I阶段项目的更广泛的影响/商业潜力将推进一种新型的药物输送。蛋白质药物（生物制剂）由于其活性的高特异性和副作用水平较低而变得越来越流行。生物制剂治疗许多疾病，影响数百万患者的生活，并且全球收入超过100美元。患者更喜欢并遵守可注射版的生物制剂，因为注射速度迅速并且可以使家居管理量可以持续数小时。但是，许多生物制剂的发展和实用性因其无法通过注射而无法使用，因为它们是厚的液体。该项目中开发的技术将作为早期筛查，以确定潜在的药物制剂对注射的适用性，从而实现新药。该SBIR I期项目将通过提供蛋白质配方粘度的早期筛查来增加基于可注射蛋白的疗法的数量。目前不可能在配方开发的早期进行粘度测量，因为现有的粘度指标需要较高的材料量。因此，直到开发大量材料，通常在临床前研究的后期才能测试新的基于蛋白质的制剂的注射性。该项目将创建一个高通量的粘度计，该粘度计需要每个测试的掉落，以进行配方优化；它将确定在同一基板上多路复用微流体石英传感器以实现同时粘度测量的可行性。具体而言，在该项目中，1）将开发多路复用传感器的电子设备，2）多路复用传感器将使用分析和有限元模型设计，以及3）这些设计将通过微型制动来执行。最后，将通过同时分析相关配方来测试多重的微流体石英传感器。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的智力优点和更广泛影响的评估标准的评估来获得支持的。