SBIR Phase II: Development of a simple device that eliminates bottlenecks in radiopharmaceutical production

SBIR 第二阶段：开发一种简单的设备，消除放射性药物生产的瓶颈

• 批准号: 1555815
• 负责人: Arkadij Elizarov
• 金额: $ 75万
• 依托单位: Trace-Ability, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-01 至 2020-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1555815&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; simple

This Small Business Innovation Research Phase II project aims to deliver a cost-effective automated quality control (QC) system for manufacturing of radioactive drugs used in Positron Emission Tomography (PET). This system will replace current QC procedures, which involve 18 manual operations, 8 visual assessments, 6 devices, and 8 samples of radioactive drugs. The industry's current reliance on manual operation, subjectivity and untraceable records impedes progress in radioactive drug manufacturing and presents compliance risks. Therefore, introduction of an automated system combining all these tests on a single platform will facilitate adoption of PET imaging technology beyond top tier medical centers. By addressing a critical current Good Manufacturing Practice (cGMP) compliance need in radio-pharmaceutical production, which cannot be addressed with any other solutions available today, this solution is positioned for rapid adoption. After adopting this system, it is expected that manufacturing facilities will realize 20% operating cost reduction and 50% reduction in time spent on QC-related activities. A reduced cost of compliance associated with introduction of automated QC will further contribute to the adoption rate. This project will open the door to new applications of plate reader technology, an approach which has been traditionally confined to the fields of biochemistry and diagnostics. This Phase II effort includes four technical objectives. Firstly, the approach will be adapted to minimize the required sample volume. Methods developed in Phase I of the project required 0.5 ml of sample, a value which is not optimal for small manufacturers. To bring this value down to 0.2 ml, test sensitivity will be adjusted, keeping in mind the potential dynamic range trade-offs. Secondly, we will design a plastic consumable that supports adoption by a commercial manufacturer. Current plastic prototype components are only suitable for academic sites with highly-skilled personnel. To reduce the amount of training required, and to expand the applicability of this method, a new plastic component will be designed in order to further automate sample loading. Third, we will optimize the formulation of the reagents to achieve a one-year shelf life for the consumable kit. The shelf life of the reagents developed in Phase I remains unknown. Therefore, accelerated stability studies will be performed to estimate the rates of decomposition processes, and appropriate changes will be made to enhance shelf life. Finally, we will develop a pilot production process for the newly-designed kit, in order to support early installations.

这个小型企业创新研究第二阶段项目旨在为正电子发射断层扫描(PET)中使用的放射性药物的生产提供具有成本效益的自动化质量控制(QC)系统。该系统将取代目前的质控程序，后者涉及18个人工操作、8个视觉评估、6个设备和8个放射性药物样本。该行业目前对人工操作、主观性和无法追踪的记录的依赖阻碍了放射性药物制造的进展，并存在合规风险。因此，引入一个在单一平台上结合所有这些测试的自动化系统将有助于在顶级医疗中心以外采用PET成像技术。通过满足目前放射性药品生产中符合良好制造规范(CGMP)的关键需求，这一需求无法用目前现有的任何其他解决方案来解决，该解决方案适合快速采用。采用该系统后，预计制造设施将实现20%的运营成本降低和50%的QC相关活动时间减少。与引入自动化QC相关的合规成本降低将进一步促进采用率。该项目将为平板阅读器技术的新应用打开大门，这种方法传统上仅限于生物化学和诊断学领域。这项第二阶段的工作包括四个技术目标。首先，将采用该方法，以最大限度地减少所需的样本量。该项目第一阶段开发的方法需要0.5毫升样本，对于小型制造商来说，这个数值并不是最理想的。要将此值降至0.2毫升，将调整测试灵敏度，同时考虑到潜在的动态范围权衡。其次，我们将设计一种支持商业制造商采用的塑料消耗品。目前的塑料原型部件只适用于拥有高技能人员的学术场所。为了减少所需的训练量，并扩大这种方法的适用性，将设计一种新的塑料部件，以进一步实现样品加载的自动化。第三，优化试剂配方，实现耗材试剂盒保质期一年。在第一阶段开发的试剂的保质期尚不清楚。因此，将进行加速稳定性研究，以估计分解过程的速度，并将进行适当的改变，以延长货架期。最后，我们将为新设计的套件开发试生产流程，以支持早期安装。