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.

这项小企业创新研究（SBIR）第一阶段项目的广泛影响/商业潜力推动了一种新型药物输送。基于蛋白质的药物（生物制剂）由于其高特异性的活性和通常低水平的副作用而变得越来越受欢迎。生物制剂可以治疗多种疾病，影响数百万患者的生命，全球收入超过1000亿美元。患者更喜欢并遵守可注射的生物制剂，因为注射速度快，可以在家给药，而不像静脉输液需要持续数小时的诊所。然而，许多生物制剂的开发和应用受到阻碍，因为它们是粘稠的液体，无法通过注射使用。在这个项目中开发的技术将作为早期筛选，以确定潜在的注射药物配方的适用性，从而实现新药的输送。这个SBIR一期项目将通过提供蛋白质配方粘度的早期筛选来增加可注射蛋白质治疗药物的数量。在配方开发的早期粘度测量目前是不可能的，因为现有的粘度计需要高材料体积。因此，在开发出大量材料之前，通常在临床前研究的后期阶段，无法测试新的蛋白质基制剂的可注射性。该项目将创建一个高通量粘度计，每次测试只需要滴液，以优化配方；它将确定在同一衬底上复用微流体石英传感器以实现同时粘度测量的可行性。具体来说，在这个项目中，1)将开发多路复用传感器的电子器件，2)多路复用传感器将使用分析和有限元模型进行设计，3)这些设计将通过微制造来执行。最后，对多路微流控石英传感器进行测试，同时分析相关配方。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。