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

第一阶段小企业创新研究（SBIR）项目的更广泛影响/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。尽管具有极具吸引力的特性，但生产符合严格药典要求的高特异性活性I-131产品极具挑战性；高比活度的产物只有通过锕系元素的裂变才能产生，比如铀。这一途径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。SHINE医疗技术公司正在研究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，它们没有有效的保质期，也不能储存。拥有国内供应商对供应和物流问题至关重要。缓解这种供应问题将大大降低依赖这些有益保健产品的患者的健康风险。由于制造业设在美国，SHINE可以为威斯康星州的经济创造许多高科技、高薪的工作岗位。这一第一阶段研究项目的目标是更好地了解并因此控制碘在水均质核辐照容器中的氧化状态，以便提取和纯化供医疗使用。碘具有丰富的化学性质，特别是在水系统中，并受到α、β、γ和x辐射的大量照射。不控制它的氧化态，我们就不能控制它的化学形态，因此也就不能控制它从辐照水溶液中的提取和纯化。放射性碘的提取非常复杂，因为需要继续努力提取更有价值的钼-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。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。

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.