SBIR Phase I: Development of a Novel Process for the Manufacture of Iodine-131 for Medical Use

SBIR 第一阶段：开发医用 Iodine-131 制造新工艺

• 批准号: 1519251
• 负责人: Jeff Driscoll
• 金额: $ 14.97万
• 依托单位: SHINE Medical Technologies, 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: 2015-07-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1519251&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Novel; Process

The broader impact/commercial potential of this Phase I Small Business Innovation Research (SBIR) project is to provide a domestic manufacturing source of the critical medical isotope Iodine-131 (I-131). I-131 is the primary therapeutic for several malignancies and is a key element of several new cancer treatment medicines. Despite its highly attractive features, manufacturing a high-specific activity I-131 product in conformance with strict pharmacopeial requirements is extremely challenging; the high specific activity product is only made by fissioning actinides, such as uranium. This route, although more complicated than the neutron irradiation of tellurium, produces a more favorable product in terms of ease of use and efficacy. SHINE Medical Technologies, Inc. is working on a highly innovative, fissioning technology for manufacturing manufacture several important medical isotopes here in the U.S. Due to the transitory nature of medical isotopes, they have no meaningful shelf life and cannot be stockpiled. Having a domestic supplier is critical to supply and logistics issues. Alleviating such supply concerns will considerably reduce the health risk to patients who rely on these beneficial healthcare products. With manufacturing located in the U.S., SHINE could create a number of high-technology, well-paying jobs for the economy of Wisconsin.The objectives of this Phase I research project are to better understand and, thus, control the oxidation state of iodine in an aqueous homogeneous nuclear irradiation vessel so that it may be extracted and purified for medical use. Iodine has a rich chemistry, particularly in an aqueous system and which is subjected to considerable irradiation by alpha, beta, gamma and x radiation. Without controlling its oxidation state, we cannot control its chemical speciation and, therefore, its extraction and purification from the irradiated aqueous solution. Extraction of the radioiodine is greatly complicated by the need to preserve efforts to extract the more valuable Mo-99 and eliminate impact on other safety and environmental concerns of the chemical plant (corrosion control, waste management, etc.) Accomplishing these goals will allow SHINE to become a domestic manufacturer of I-131 (as well as other medical isotopes) relieving supply issues and risks for patients and healthcare providers.

该第一阶段小企业创新研究 (SBIR) 项目更广泛的影响/商业潜力是提供关键医用同位素碘 131 (I-131) 的国内制造来源。 I-131 是多种恶性肿瘤的主要治疗药物，也是多种新型癌症治疗药物的关键成分。尽管 I-131 具有极具吸引力的特性，但制造符合严格药典要求的高比活性 I-131 产品极具挑战性；高比活度产物仅由裂变锕系元素（例如铀）制成。该路线虽然比碲的中子辐照更复杂，但在易用性和功效方面产生了更有利的产品。 SHINE Medical Technologies, Inc. 正在美国开发一种高度创新的裂变技术，用于制造几种重要的医用同位素。由于医用同位素的短暂性，它们没有有意义的保质期，无法储存。拥有国内供应商对于供应和物流问题至关重要。 缓解此类供应问题将大大降低依赖这些有益医疗产品的患者的健康风险。 由于制造位于美国，SHINE 可以为威斯康星州的经济创造大量高科技、高薪就业机会。该第一阶段研究项目的目标是更好地了解并从而控制水均质核辐照容器中碘的氧化态，以便将其提取和纯化用于医疗用途。 碘具有丰富的化学性质，特别是在水性体系中，并且会受到 α、β、γ 和 X 辐射的大量照射。 如果不控制其氧化态，我们就无法控制其化学形态，因此也无法控制其从辐照水溶液中的提取和纯化。 由于需要继续努力提取更有价值的 Mo-99 并消除对化工厂其他安全和环境问题（腐蚀控制、废物管理等）的影响，放射性碘的提取变得非常复杂。实现这些目标将使 SHINE 成为 I-131（以及其他医用同位素）的国内制造商，从而缓解患者和医疗保健提供者的供应问题和风险。