SBIR Phase II: High Throughput Static Light Scattering Platform for Monitoring of Aggregation and Stability of Protein Solutions

SBIR 第二阶段：用于监测蛋白质溶液聚集和稳定性的高通量静态光散射平台

• 批准号: 1430434
• 负责人: Michael Drenski
• 金额: $ 75万
• 依托单位: Advanced Polymer Monitoring Technologies, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-10-01 至 2018-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1430434&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Throughput; Static

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project, if successful, will have immediate value for the pharmaceutical industry by accelerating research and discovery of new drugs, and also increasing production efficiency and safety. The technology also is applicable in many other sectors; e.g., monitoring natural polymers, such as dissolution of gelatin used in food or pharmaceutical applications, flocculation of impurities by water purification polymers, entrapment of oil by surfactants and other agents used in combating oil spills, and more. The quantitative kinetics of molecular weight changes during all these processes will allow deeper understanding of the fundamental physical and chemical forces that drive them. Therefore, many commercial and scientific opportunities exist for the proposed technology, yielding the potential for significant impact across multiple industries. With demonstrated feasibility on applications in protein therapeutics and early adoption by several key users, the initial market for this technology and instrumentation could expand quickly, and sales could reach $10M within several years of delivering a commercial product. The overall market for the technology will increase in time as other application sectors are developed.This SBIR Phase II project proposes to develop a new technology for monitoring aggregation in therapeutic protein solutions, which will have wide-ranging impact in the pharmaceutical and biotechnology industries. Protein aggregation is a major problem across these sectors engaged in developing new protein pharmaceuticals. Protein aggregation can elicit immune responses against the protein itself, severely reduce bioavailability, and is a significant hurdle in the drug development pipeline. This new technology can simultaneously and quantitatively monitor the stability of many independent protein formulations for hours, days, months, or longer, all under the control of a single instrument and without any significant human intervention. Because the technology is based on laser light scattering, it provides a rigorous means of monitoring the protein aggregation process. It is based on fundamental laws of physics, and not on empirical or inferential means. The implementation and use of this technology could revolutionize drug discovery, formulation, and quality control dimensions and accelerate development of new drugs while making existing ones safer and more efficiently produced. The technology can be used wherever proteins are under development for fighting diseases such as cancer, Alzheimer's, diabetes, and various forms of cardiovascular disease.

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力，如果成功的话，将通过加速新药的研究和发现，以及提高生产效率和安全性，对制药行业产生直接价值。该技术也适用于许多其他部门;例如，监测天然聚合物，如食品或制药应用中使用的明胶的溶解、水净化聚合物对杂质的絮凝、表面活性剂和其他用于防止漏油的试剂对油的截留等。 在所有这些过程中分子量变化的定量动力学将使我们更深入地了解驱动它们的基本物理和化学力。因此，所提出的技术存在许多商业和科学机会，有可能对多个行业产生重大影响。随着蛋白质治疗应用的可行性得到证明，以及几个关键用户的早期采用，这项技术和仪器的初始市场可能会迅速扩大，在交付商业产品后的几年内，销售额可能会达到1000万美元。 随着其他应用领域的发展，该技术的整体市场将不断增长。SBIR第二阶段项目提出开发一种新技术，用于监测治疗性蛋白质溶液中的聚集，这将对制药和生物技术行业产生广泛的影响。蛋白质聚集是这些从事开发新蛋白质药物的部门的主要问题。蛋白质聚集可以引起针对蛋白质本身的免疫反应，严重降低生物利用度，并且是药物开发管道中的一个重要障碍。这项新技术可以同时定量监测许多独立蛋白质制剂的稳定性，持续数小时、数天、数月或更长时间，所有这些都在单一仪器的控制下，无需任何人为干预。 由于该技术基于激光散射，因此它提供了一种严格的监测蛋白质聚集过程的方法。 它是基于物理学的基本定律，而不是基于经验或推理的手段。该技术的实施和使用可以彻底改变药物发现，配方和质量控制方面，并加速新药的开发，同时使现有药物更安全，更有效地生产。 该技术可用于任何正在开发蛋白质的地方，以对抗癌症，阿尔茨海默氏症，糖尿病和各种形式的心血管疾病。