SBIR Phase I: Development of a simple device that eliminates bottlenecks in radiopharmaceutical production

这个小企业创新研究第一阶段项目将实现一项颠覆性技术，提高为正电子发射断层扫描(PET)提供成像示踪剂的核药房的效率和能力。PET代表了最强大的医学成像方式，但其可用性受到核药房吞吐能力的严重限制。这项拟议的努力将消除这一瓶颈，并使依赖PET进行肿瘤学、心脏病学和神经学准确诊断的患者获得PET医学成像的根本性改善。预计2013至2018年间，正电子发射计算机断层扫描的数量将从700万次增加到1900万次。然而，核制药行业的当前状况将不会支持这种增长，除非它改变目前的合规检查和质量控制的人工方法。该项目的目标是为这些繁琐且昂贵的任务开发自动化解决方案。对这种新产品的需求已经很明显，潜在市场估计为5亿美元。一旦拟议的技术在核制药行业得到验证，预计同一平台将在其他需要定期进行多参数测试的行业中找到应用(例如废水或食品检验)。这个项目的智力价值在于开发了两种创新的分析方法，可以使用商业平板阅读器来实现。第一种是使用液体闪烁计数(LSC)的放射性测量。该项目将使平板阅读器中的LSC能够在发光读取模式下运行。在这项工作中，放射性样品将与闪烁材料混合，预计将产生可量化的发光信号。第二个测试是对一种通常用于合成PET成像示踪剂的密码进行量化。该计划是开发一种比色指示器，通过测量由于密码和指示器在平板阅读器中的结合而产生的颜色的吸光度来量化这种密码。这些测试是需要验证的两个关键组件，以证明具有单一平板读取器且读取器和样本之间没有任何接触的短寿命放射性药物产品的完整、自动化质量控制(QC)。目前，这一相同的质量控制过程需要使用多台仪器进行10至14次手动测试，其中大多数仪器与样品接触，需要清洗和平衡。

This Small Business Innovation Research Phase I project will enable a disruptive technology that increases the efficiency and capacity of nuclear pharmacies that supply imaging tracers for Positron Emission Tomography (PET). PET represents the most powerful medical imaging modality, yet its availability is severely limited by the nuclear pharmacy throughput capacity. The proposed effort will remove this bottleneck and lead to a radical improvement in the availability of medical imaging with PET to the patients who depend on it for accurate diagnosis in oncology, cardiology and neurology. The number of PET scans is projected to grow from 7 to 19 million between 2013 and 2018. However, the current state of the nuclear pharmacy industry will not support such growth unless it switches from current manual methods for compliance checking and quality control. The goal of this project is to develop automated solutions for these cumbersome and expensive tasks. The demand for this new product is already apparent and the addressable market is estimated at $500 million. Once the proposed technology is proven in the nuclear pharmacy industry, it is envisioned that the same platform will find applications in other industries that require regular multi-parametric testing (e.g. wastewater or food inspection). The intellectual merit of this project is in the development of two innovative analytical methods that can be implemented using a commercial plate reader. The first one is a radioactivity measurement using Liquid Scintillation Counting (LSC). This project will enable LSC in a plate reader operating in luminescence reading mode. In this effort, the radioactive sample will be mixed with scintillating material and is expected to produce a quantifiable luminescence signal. The second test is quantification of a cryptand commonly used in the synthesis of PET imaging tracers. The plan is to develop a colorimetric indicator that allows quantification of this cryptand by measuring the absorbance of color resulting from the binding of cryptand with indicator in a plate reader. These tests are the two critical components that need to be proven in order to demonstrate complete, automated quality control (QC) of a short-lived radiopharmaceutical product with a single plate reader, and without any contact between the reader and the sample. Currently, this same QC process requires 10 to 14 manual tests done using multiple instruments, most of which come in contact with the sample and need to be cleaned and equilibrated.