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

SBIR 第一阶段：开发一种简单的设备，消除放射性药物生产的瓶颈

• 批准号: 1446677
• 负责人: Artem Lebedev
• 金额: $ 15万
• 依托单位: Trace-Ability, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1446677&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; simple; device

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.

这个小型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模式，但其可用性受到核药剂吞吐量的严重限制。 拟议的努力将消除这一瓶颈，并导致从根本上改善PET医学成像的可用性，以帮助依赖PET进行肿瘤学、心脏病学和神经病学准确诊断的患者。 PET扫描的数量预计将在2013年至2018年期间从700万增加到1900万。然而，核制药业的现状将不支持这种增长，除非它从目前的手动方法转换为合规检查和质量控制。 该项目的目标是为这些繁琐而昂贵的任务开发自动化解决方案。 对这一新产品的需求已经很明显，可寻址市场估计为5亿美元。 一旦所提出的技术在核制药行业得到证明，可以预见，同一平台将在需要定期多参数测试的其他行业（例如废水或食品检测）中找到应用。该项目的智力价值在于开发了两种创新的分析方法，可以使用商业酶标仪实施。第一种是使用液体闪烁计数（LSC）进行放射性测量。 本项目将在以发光阅读模式运行的酶标仪中启用LSC。 在这项工作中，放射性样品将与荧光材料混合，并预计产生可量化的发光信号。第二个测试是定量的穴状配体通常用于合成PET成像示踪剂。该计划是开发一种比色指示剂，通过在酶标仪中测量穴状配体与指示剂结合产生的颜色吸光度来定量该穴状配体。这些测试是需要证明的两个关键组成部分，以证明使用单个酶标仪对短寿命放射性药物产品进行完整的自动质量控制（QC），并且酶标仪与样品之间没有任何接触。 目前，相同的QC过程需要使用多台仪器进行10到14次手动测试，其中大部分仪器与样品接触，需要进行清洁和平衡。