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: 10569024
• 负责人: Zehra Parlak
• 金额: $ 90.13万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10569024
• 关键词: Acoustics; Address; Antibody Therapy; Behavior; Biological Products; Blood capillaries; Clinic; Computer software; Data; Development; Devices; Dimensions; Dose; Drops; Elasticity; Ensure; FDA approved; Failure; Formulation; Health Care Costs; Health care facility; Height; Home; Industry; Injectable; Injections; Intravenous infusion procedures; Investments; Liquid substance; Marketing; Measurement; Measures; Microfluidics; Modulus; Monoclonal Antibodies; Motion; Patient Preferences; Patients; Phase; Positioning Attribute; Process; Proteins; Quartz; Rheology; Risk; Risk Reduction; Sampling; Side; Small Business Innovation Research Grant; Subcutaneous Injections; Surface; System; Techniques; Technology; Testing; Therapeutic; Thick; Thinness; Time; Viscosity; candidate selection; commercialization; cost; data acquisition; drug development; fabrication; improved; injection/infusion; instrument; manufacturability; manufacture; milliliter; phase 1 study; preclinical development; protein protein interaction; prototype; research and development; scale up; screening; 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.

SBIR II期建议的目的是携带Qatch的Nanovisq™技术，这是一种广泛的 用于确定生物制药的发展和注射性的剪切率范围和低容量粘度计 公式，从概念验证到可部署和可靠的原型。这个目标是由 不断增长的基于蛋白质的生物药物治疗行业的需求（全球市场规模超过100美元 十亿）。由于体积，基于蛋白质的治疗剂是作为高浓度公式的 皮下注射的约束。但是，在这些高的蛋白质蛋白相互作用增加 浓度可能会引起注射性和制造问题，这些问题无法在早期阶段确定 由于常规流变技术的样本体积要求高的样本需求而引起的药物开发。经过 开发较大的剪切速率范围，低容量粘度计，蛋白质分子可以优化 可以选择具有更好开发的注射性/可制造性和候选人进行扩展。这 提案很重要，因为提出的设备可以在早期评估蛋白质公式的注射性 药物开发比现有技术，因此减少了研发支出的时间和成本 经过考虑开发新的，可注射蛋白的疗法。在SBIR I期研究中，Qatch具有 成功地扩展了Nanovisq™的粘度测量的剪切率范围 高浓度蛋白溶液的表征。结果，Nanovisq™现在位于 非常适合粘度测量高浓度蛋白配方。在SBIR II期中，Qatch是 提议1）开发基于牺牲多s的制造工艺，以在石英摇动上构建微流体， 2）为Nanovisq™传感器开发原型控制和数据采集模块。开发可部署和 可靠的Nanovisq™传感器和仪器将是该技术商业化的关键步骤。