Iodine-124: Target and Production Business

描述(由申请人提供)：建议制定用于商业分配的碘-124的生产目标，并发展I-124放射性示踪剂的放射性标记业务。I-124是一种越来越有用的核素，用于正电子发射断层扫描，特别是标记需要长时间实验的分子，如抗体或其他大分子，包括纳米颗粒。与更常见的PET协议相比，它的商业可用性有限。单一垄断的外资供应商的价格高得令人望而却步。在美国增加有竞争力的核素供应是这项工作的理想结果，但这项工作的目标超出了这一范围。目前的目标设计是低产量的，对商业生产来说微不足道。目标性能的提高将提供更经济的生产环境和更低的价格。通过向大规模生产商提供商业上可行的目标，我们将鼓励增加产量和更多的生产地点。这将允许更经济的生产和分销模式，使I-124得到普遍使用，这项工作最重要的目标可能是将I-124目前的商业模式扩展到简单的生产和分销之外。我们在潜在的生产商中是独一无二的，拥有完全有能力的放射化学实验室和有能力和经验的放射化学家来执行放射性标记。放射性核素将用于生产各种有用的放射性药物，供缺乏放射合成设施的客户使用。我们将提供定制标签服务，以准备由客户生产或拥有的专有标记抗体和其他材料。自定义标签产品将交付用于PET扫描实验。预计这将吸引学术和工业客户，包括大型制药公司。与公共卫生相关：碘-124具有相当大的临床广泛应用潜力，以及更迫切的研究用途需求。它提供的经济和科学优势适用于临床相关疗法的研究和开发。这些主要用于癌症治疗，但也用于医学研究的所有其他领域。这项工作将直接影响医疗实践和新药发展的速度和成本。所有这一切都需要获得放射性核素和含有放射性核素的放射性示踪剂，这是本提案的主题。该提案将为I-124制定一个新的商业生产目标，并建立一个以生产带有I-124标签的材料为基础的业务。直接的影响将是各种类型的医学研究成本的降低，以及用于成像和治疗的候选抗体的廉价和高通量筛选。

DESCRIPTION (provided by applicant): It is proposed to develop a target for production of iodine-124 for commercial distribution and to develop a radiolabeling business for I-124 radiotracers. I-124 is an increasingly useful nuclide for positron emission tomography, especially to label molecules, such as antibodies or other macromolecules including nanoparticles, that require long-duration experiments compared to more common PET protocols It has limited commercial availability. There is a prohibitively high price from a single monopolistic foreign-owned supplier. An additional competitive supply of the nuclide in the United States is a desirable outcome of this work, but the goal of the work reaches beyond that. Current target designs are low-yield and marginal for commercial production. Improvement in the target performance will provide a more economical production environment and lower price. By making a commercially feasible target available to large-scale producers we will encourage increased production and a larger number of production sites. This will allow more economical production and distribution patterns to allow I-124 to be commonly used Possibly the most significant goal of this work is to expand the current business model for I-124 beyond simple production and distribution. We are unique among potential producers in having a fully capable radiochemistry laboratory and capable and experienced radiochemists to perform radiolabeling. The radionuclide will be used to produce a variety of useful radiopharmaceuticals for delivery to customers who lack radiosynthesis facilities. We will offer custom labeling services to prepare proprietary labeled antibodies and other materials produced by or owned by customers. Custom labeled product will be delivered for use in PET scanning experiments. This is expected to appeal to both academic and industrial customers, including large pharmaceutical companies. PUBLIC HEALTH RELEVANCE: Iodine-124 has considerable potential for widespread clinical use as well as the more immediate demands for research use. The economic and scientific advantages that it offers apply to research and development of clinically relevant therapies. These are primarily for cancer treatment but also for all other areas of medical research. This work will have a direct impact on the speed and cost of development of advances in medical practice and of new drugs. All of this requires availability of the radionuclide and of radiotracers that incorporate it, which are the subject of this proposal. The proposal will develop a new commercial production target for I-124 and a business based on production of materials labeled with I-124. The immediate impact will be a reduction in cost of a variety of types of medical research, and inexpensive and higher-throughput screening of antibody candidates for imaging and therapy.