I-Corps: Chemical processes for preparation of diagnostic agents for Positron Emission Tomography imaging

这个i-Corps项目的更广泛的影响/商业潜力是准备用于疾病早期检测的新一代诊断产品，并评估正电子发射断层扫描(PET)成像疗法。PET成像使用放射性示踪剂(用安全的放射性材料标记的药物和生物分子)在细胞和分子水平上提供有关生物事件的信息。这种检测对于乳腺癌等疾病的早期诊断以及对免疫治疗反应的评估都是必要的。目前，很少有化学工艺可以工业化生产放射性示踪剂。典型的流程使用非商业供应商(放射性药物)生产的放射性材料，这反过来又使这些放射性示踪剂的生产变得昂贵。因此，这些材料并不是很容易获得。该项目使用了一种新的化学工艺，其中使用了放射性药物中的放射性物质。这种化学工艺适用于商业放射性药物，因此他们可以在现场制造放射性示踪剂，提供给最终用户。由于这些商业放射性药物通常建立了巨大的分销渠道，更多的患者，包括那些资源不足的地区的患者，将能够从这些更便宜、更好的诊断产品中受益。I-Corps项目进一步开发了一种新技术，用于制备用于正电子发射断层扫描(PET)的新一代放射性示踪剂。这一创新结合了特定的试剂、反应条件和化学过程，从而能够制备标记的生物分子。这项技术使用了商业回旋加速器直接生产的盐。这里开发的方法允许在标记过程的最后一步将放射性核素添加到感兴趣的生物分子中，保留产品的放射性并显著提高放射化学产率。这项技术允许制备多种放射性示踪剂，应用于检测神经疾病、癌症、药物药代动力学、新陈代谢和靶向参与，以及制备双重显像剂。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is to prepare a new generation of diagnostic products for early detection of diseases and to evaluate Positron Emission Tomography (PET) Imaging therapies. PET imaging uses radiotracers (drugs and biomolecules labeled with safe radioactive materials) to provide information about biological events on a cellular and molecular level. Such tests are necessary for the early diagnosis of diseases such as breast cancer as well as the evaluation of responses to immunotherapy. Currently, there are few chemical processes to produce radiotracers on an industrial scale. Typical processes use radioactive materials that are not produced by commercial vendors (radiopharmacies) and this, in turn, makes the production of these radiotracers expensive. Hence, the material is not widely accessible. This project uses a new chemical process in which radioactive materials from radiopharmacies are used. The chemical process is adaptable by commercial radiopharmacies so they can make the radiotracers on-site to provide to end users. Since these commercial radiopharmacies typically have established large distribution channels, more patients, including those in under-resourced areas, will be able to benefit from these cheaper and better diagnostic products.This I-Corps project further develops a novel technology in the preparation of a new generation of radiotracers for use in Positron Emission Tomography (PET). The innovation combines specific reagents, reaction conditions, and chemical processes to allow the preparation of labeled biomolecules. The technology uses salts that are directly produced in commercial cyclotrons. The process developed here allows the radionuclide to be added to the biomolecule of interest in the last step of the labeling process, retaining the radioactivity of the product and significantly improving the radiochemical yield. The technology allows the preparation of a wide variety of radiotracers with applications in the detection of neurological disorders, cancer, drug pharmacokinetics, metabolism, and target engagement, as well as in the preparation of dual imaging agents.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.