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

开发基于微流控石英谐振器的原型可注射性和可开发性测试系统

• 批准号: 10384221
• 负责人: Zehra Parlak
• 金额: $ 59.87万
• 依托单位: QATCH TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-08 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384221
• 关键词: Acoustics; Address; Antibody Therapy; Behavior; Biological Products; Blood capillaries; Clinic; Computer software; Data; Development; Devices; Dimensions; Dose; Drops; Ensure; FDA approved; Failure; Formulation; Health Care Costs; Health care facility; Height; Home; Industry; Injectable; Injections; Intravenous infusion procedures; Investments; Liquid substance; Measurement; Measures; Microfluidics; Modulus; Monoclonal Antibodies; Motion; Patient Preferences; Patients; Pharmaceutical Preparations; Phase; Positioning Attribute; Problem Solving; Process; Proteins; Quartz; Rheology; Risk; Sampling; Side; Small Business Innovation Research Grant; Subcutaneous Injections; Surface; System; Techniques; Technology; Testing; Therapeutic; Thick; Thinness; Time; Viscosity; base; candidate selection; commercialization; cost; data acquisition; drug development; improved; instrument; manufacturability; milliliter; phase 1 study; preclinical development; protein protein interaction; prototype; research and development; scale up; sensor; stem

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.

该 SBIR 第二阶段提案的目标是采用 QATCH 的 nanovisQ™ 技术，该技术是一种广泛的 用于确定生物制药的可开发性和可注射性的剪切速率范围和低体积粘度计 从概念验证到可部署且可靠的原型，这一目标是由以下因素推动的。 不断增长的基于蛋白质的生物制药治疗行业的需求（全球市场规模超过 100 美元） 由于体积的原因，基于蛋白质的治疗剂以高浓度制剂的形式施用。 然而，皮下注射的限制增加了蛋白质-蛋白质相互作用。 浓度可能会导致可注射性和可制造性问题，这些问题无法在早期阶段确定 由于传统流变学技术对样品量的要求很高，因此药物开发的难度很大。 开发宽剪切速率范围、低体积粘度计，可以优化蛋白质分子 可以选择可注射性/可制造性和具有更好可开发性的候选物进行放大。 该提案意义重大，因为所提出的设备可以在早期评估蛋白质制剂的可注射性 药物开发优于现有技术，从而减少研发时间和成本 在 SBIR I 期研究中，QATCH 大力开发新的、可注射的基于蛋白质的疗法。 成功扩展了 nanovisQ™ 粘度测量的剪切速率范围，以实现正确的粘度测量 因此，nanovisQ™ 现在的定位是： 非常适合高浓度蛋白质配方的粘度测量。 建议 1) 开发一种基于牺牲多晶硅的制造工艺，在石英晶片上构建微流体， 2) 开发用于 nanovisQ™ 传感器的原型控制和数据采集模块。 可靠的 nanovisQ™ 传感器和仪器将是该技术商业化的关键一步。