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启用一种颠覆性技术，提高核药房的效率和能力，为正电子发射断层扫描（PET）提供成像示踪剂。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量的严重限制。所提出的努力将消除这一瓶颈，并导致PET医学成像的可用性的根本改善，这些患者依赖于肿瘤，心脏病学和神经学的准确诊断。PET扫描的数量预计将从2013年的700万次增加到2018年的1900万次。然而，核制药行业目前的状况将不支持这种增长，除非它从目前的人工方法转向合规检查和质量控制。这个项目的目标是为这些繁琐和昂贵的任务开发自动化的解决方案。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。一旦提议的技术在核制药行业得到证实，设想相同的平台将在需要定期多参数测试（例如废水或食品检测）的其他行业中得到应用。这个项目的智力价值在于开发了两种创新的分析方法，可以使用商用车牌阅读器来实现。第一个是使用液体闪烁计数（LSC）进行放射性测量。本项目将使LSC在车牌读取器中以发光读取模式工作。在这项工作中，放射性样品将与闪烁物质混合，并有望产生可量化的发光信号。第二个测试是量化通常用于PET成像示踪剂合成的密码体。该计划是开发一种比色指示剂，该指示剂可以通过测量在平板阅读器中由指示剂与密码体结合而产生的颜色吸光度来定量该密码体。这些测试是需要验证的两个关键组成部分，以便演示使用单个平板读取器对短寿命放射性药物产品进行完整的自动化质量控制（QC），并且读取器与样品之间没有任何接触。目前，同样的QC过程需要使用多个仪器进行10到14次手动测试，其中大多数与样品接触，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.