SBIR Phase II: PET Radiotracer Synthesis

这个小型企业创新研究第二阶段项目开发正电子发射断层扫描(PET)成像产品，以管理神经退行性疾病、癌症和心血管疾病。PET现在是肿瘤学中的关键诊断和管理工具，而标记有[18F]-氟化物的化合物在医学成像应用中提供了最佳的信噪比和分辨率。地面氟制药公司(GFP)开发了专有的单步氟化技术，使回旋加速器生产的[18F]-氟化物能够有效地制备[18F]标记的药物。在这一第二阶段的研究项目中，绿色荧光蛋白将应用其新技术生产显像剂6-[18F]氟-L-多巴(FDOPA)，这是一种用于诊断帕金森氏症和癌症成像的化合物，由于生产困难，目前尚不容易获得。GFP将在制药cGMP条件下放大和制造药用级ALPDOPA(GFP的前体FDOPA)，并为研究和临床成像提供这种材料。GFP将开发FDA的药物主文件，并将向采用GFP技术用于商业生产FDOPA的回旋加速器药房客户提供技术和监管援助。除了帮助将这种有价值的显像剂推向市场外，GFP还将帮助学术和制药研究小组开发新的[18F]氟化成像产品。更广泛的影响/商业潜力是扩大PET作为医疗诊断工具的范围和用途，从而改善严重医疗问题的治疗和管理。虽然[18F]-氟化物可能具有最有利的成像性能，相对便宜，并且可以广泛获得，但它很难被加入到用于成像的药物中。GFP已经开发出一种通用的使能技术，它使用相对便宜和广泛可用的[18F]-氟化物形式来创建新的分子显像剂，以促进个性化药物的发展。这项技术及其产生的化合物将为医生提供新的机会来诊断、评估和更有效地治疗未得到满足的医疗需求。这里开发的制造技术是一个广泛适用于制备各种新型显像剂的广阔平台。PET成像的商业潜力是巨大的；到2015年，全球PET市场预计将增长到150亿美元。

This Small Business Innovation Research Phase II project develops positron emission tomography (PET) imaging products to manage neurodegenerative disorders, cancer, and cardiovascular disease. PET is now a key diagnostic and management tool in oncology, and compounds labeled with [18F]-fluoride provide optimal signal to noise ratios and resolution in medical imaging applications. Ground Fluor Pharmaceuticals (GFP) developed proprietary single-step fluorination technology that allows [18F]-labeled medicines to be prepared efficiently from cyclotron-produced [18F]-fluoride. Under this Phase II research project GFP will apply its new technology to produce the imaging agent 6- [18F]fluoro-L-DOPA (FDOPA), a compound useful in diagnosing Parkinson's disease and in cancer imaging, that is not currently readily available because of the difficulty in its production. GFP will scale-up and manufacture pharmaceutical grade ALPDOPA (GFP's precursor to FDOPA) under pharmaceutical cGMP conditions, and offer this material for research studies and for clinical imaging. GFP will develop an FDA drug master file and will provide technical and regulatory assistance to cyclotron pharmacy customers adopting GFP's technology for commercial production of FDOPA. In addition to helping to bring this valuable imaging agent to market, GFP will assist academic and pharmaceutical research groups in the development of new [18F]- fluorinated imaging products. The broader impact/commercial potential is to expand the scope and utility of PET as medical diagnostic tool, thereby improving treatment and management of serious medical problems. Although [18F]-fluoride possesses, perhaps, the most advantageous properties for imaging, is relatively inexpensive, and is widely available, it is difficult to incorporate into medicines for imaging. GFP has developed a general enabling technology that uses the relatively inexpensive and widely available form of [18F]-fluoride to create new molecular imaging agents to advance personalized medicine. This technology, and the compounds it creates, will provide the physician with new opportunities to diagnose, assess, and more efficiently treat unmet medical needs. The manufacturing technology developed here is a broad platform applicable to the preparation of a wide range of new imaging agents. The commercial potential of PET imaging is significant; the worldwide market for PET is expected to grow to $15 billion by 2015.