Developing prototype injectability and developability testing system based on microfluidic quartz resonators

这项SBIR第二阶段计划的目标是携带卡塔尔航空公司的NanvisQ™技术，这是一种广泛的- 测定生物药物可开发性和可注射性的剪切速率范围和低体积粘度计 配方，从概念验证到可部署和可靠的原型。这一目标是由 不断增长的基于蛋白质的生物制药治疗行业(全球市场规模超过100美元)的需求 十亿美元)。基于蛋白质的疗法由于体积大而被作为高浓度制剂给予。 皮下注射的限制。然而，在这些高水平下，蛋白质之间的相互作用增加 浓度可导致可注射性和可制造性问题，这在早期阶段无法确定 由于传统流变学技术对样品量的要求较高，因此药物开发的效率较高。通过 开发一种剪切速率范围宽、体积小的粘度计，可以优化蛋白质分子 可选择可注入性/可制造性和可开发性较好的候选材料进行放大。这 这项提议意义重大，因为拟议的设备可以在更早的时候评估蛋白质配方的注射性 药物开发比现有技术更好，从而减少了研发所花费的时间和成本 大力发展新的、可注射的基于蛋白质的疗法。在SBIR第一阶段研究中，QATCH有 成功地扩展了NanvisQ™粘度测量的剪切速率范围 高浓度蛋白质溶液的表征。因此，NanvisQ™现在的定位是 非常适合高浓度蛋白质配方的粘度测量。在SBIR第二阶段中，QATCH是 建议1)开发一种基于牺牲多晶硅的制造工艺，以在石英晶片上建立微流体， 2)研制了NanvisQ™传感器控制与数据采集原型模块。开发可部署和 可靠的NanvisQ™传感器和仪器将是该技术商业化的关键一步。

The objective of this SBIR Phase II proposal is to carry QATCH’s nanovisQ™ technology, which is a wide- shear-rate range and low volume viscometer for determining developability and injectability of biopharmaceutical formulations, from proof-of-concept to deployable, and reliable prototypes. This objective is motivated by the needs of the growing protein-based biopharmaceutical therapeutics industry (with global market size over $100 billion). Protein-based therapeutics are administered as high concentration formulations due to the volume constraints of subcutaneous injections. However, increased protein-protein interactions at these high concentrations can cause injectability and manufacturability issues, which cannot be determined at early stages of drug development due to the high sample volume requirements of conventional rheology techniques. By developing a wide shear rate range, low volume viscometer, protein molecules can be optimized for injectability/manufacturability and candidates with better developability can be selected for scaling-up. This proposal is significant because the proposed device can assess injectability of protein formulations earlier in drug development than existing technology and consequently reduce the time and cost of R&D spent in developing new, injectable protein-based therapeutics considerably. In SBIR Phase I studies, QATCH has successfully extended the shear-rate range of viscosity measurements of the nanovisQ™ for proper characterization of the high concentration protein solutions. As a result, the nanovisQ™ is now positioned to be a good fit for viscosity measurements of high concentration protein formulations. In SBIR Phase II QATCH is proposing to 1) develop a sacrificial poly-Si based fabrication process to build microfluidics on quartz wafers, 2) develop a prototype control and data acquisition module for nanovisQ™ sensors. Developing deployable and reliable nanovisQ™ sensors and instruments will be a key step in commercialization of this technology.