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

这个小企业创新研究（SBIR）第一阶段项目建议开发一种新技术，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。在开发新的蛋白质药物的这些部门中，蛋白质聚集是一个主要问题。蛋白质聚集会引发针对蛋白质本身的免疫反应，严重降低生物利用度，是药物开发管道中的一个重大障碍。这项新技术可以同时定量监测许多独立蛋白质配方的稳定性，时间为数小时、数天、数月或更长，所有这些都在一台仪器的控制下，无需任何重大的人为干预。因为这项技术是基于激光散射的，它提供了一种严格的监测蛋白质聚集过程的方法，基于基本的物理定律，而不是经验或推论的方法。这项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的情况，加速新药的开发，同时使现有药物更安全、更有效地生产。这项技术可以用于任何正在开发的蛋白质，用于对抗癌症、阿尔茨海默氏症、糖尿病和各种心血管疾病等疾病。这个项目的更广泛的影响/商业潜力，如果成功，将是制药业的价值，因为它不仅可以加速新药的研究和发现，而且还可以提高其生产效率和安全性，从而扩大其向公众提供的机会。这项技术也适用于许多其他领域；例如，监测天然聚合物，例如用于食品或制药应用的明胶的溶解，水净化聚合物对杂质的絮凝作用，表面活性剂和用于防止漏油的其他剂对油的捕获，等等。在所有这些过程中，分子质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，所提议的技术平台存在许多商业和科学机会，对多个行业产生重大影响的潜力。随着在蛋白质治疗方面应用的可行性被证明，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，在交付商业产品的几年内，销售额很容易达到1000万美元。随着其他应用领域的发展，该技术的整体市场将会增加。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a new technology for monitoring aggregation in therapeutic protein solutions that 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, 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.The broader impact/commercial potential of this project, if successful, will be the value to the pharmaceutical industry in that it can potentially accelerate not only research and discovery of new drugs, but also increase their production efficiency and safety, thereby expanding their availability to the public. The technology also has applicability 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 platform, 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 easily 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.