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

这个第一阶段小型企业创新研究(SBIR)项目的更广泛的影响/商业潜力是提供关键的医用同位素碘-131(I-131)的国内制造来源。I-131是几种恶性肿瘤的主要治疗药物，也是几种新的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，但按照严格的药典要求制造高比活度的I-131产品是极具挑战性的；高比活度的产品只能通过裂变辐系元素(如铀)来制造。这种方法虽然比碲的中子辐照更复杂，但在易用性和有效性方面产生了更有利的产品。Share Medical Technologies，Inc.正在研究一种高度创新的裂变技术，用于在美国制造几种重要的医用同位素。由于医用同位素的暂时性，它们没有意义的保质期，也不能储存。拥有一家国内供应商对供应和物流问题至关重要。缓解这种对供应的担忧将大大降低依赖这些有益保健产品的患者的健康风险。SIRE的制造位于美国，可以为威斯康星州的经济创造许多高科技、高薪的就业机会。这项第一阶段研究项目的目标是更好地了解并控制碘在含水均相核辐射容器中的氧化状态，以便提取和纯化用于医疗用途的碘。碘具有丰富的化学成分，特别是在水体系中，它会受到阿尔法、贝塔、伽马和X辐射的相当大的照射。如果不控制它的氧化状态，我们就不能控制它的化学形态，从而无法从辐照的水溶液中提取和纯化它。放射性碘的提取非常复杂，因为需要保留提取更有价值的钼-99的努力，并消除对化工厂的其他安全和环境问题(腐蚀控制、废物管理等)的影响。实现这些目标将使Share成为I-131(以及其他医用同位素)的国内制造商，缓解患者和医疗保健提供者的供应问题和风险。

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.