Establishing industrial production of components that enable expanding accessibility of PET imaging to cancer patient population.

CRP技术援助旨在为开发中的Tracer-QC产品完成以下工作。 它将建立必要的工业生产方法（特别是高精度注塑成型），以确保一致性 和Tracer-QC分析板的受控规模化生产，这些分析板目前由不可销售的可变 和昂贵的加工工艺。 CRP问题。Trace-Ability目前正集中精力将Tracer-QC试剂盒的生产规模扩大到 可以为整个PET行业提供高质量的套件。然而，有一个方面，目前的制造业 技术不具有可扩展性，并存在质量风险。它需要被一种全新的技术所取代， 支持PET行业。具体而言，它是核心Tracer-QC分析板的制造，其中所有QC 进行评估。当前板通过切割标准384孔板来制备。这样的过程是不可扩展的。它有 固有的板与板的可变性和碎片污染精确光学分析所需的威尔斯孔的高风险。 CRP溶液。Trace-Ability与安捷伦科技公司（Agilent Technologies，Inc.）制造 分析板通过注射成型。该项目旨在建立可扩展的分析板生产和再生产， 确认这些平板中所有现有的Tracer-QC检测试剂盒。 具体目标1：用于制造高质量分析板的可扩展注塑工艺。“高质量” 验收标准为（a）在400-700 nm范围内孔吸光度<0.065 Au，标准偏差（B）<0.003 Au 在空威尔斯孔中，和（c）在填充的威尔斯孔中，在500 nm处<1%。将由Agilent进行开发。Milestone：（a）Molded 平板符合所有验收标准。(b)最终成型工艺适用于每年超过200，000个板。 具体目标2：在模塑板中成功确认Tracer-QC试验。在新的板块可以包括在 可用于FDG和其他PET药物放行检测的Tracer-QC试剂盒，8项检测依赖于平板的威尔斯孔 需要检测和验证：颜色、澄清度、pH值、内毒素、Kryptofix、乙腈、乙醇和放射性 浓度.拟议工作将在Trace-Ability进行。里程碑：验证结果符合所有ICH Q2（R1） 所有试验的验收标准。 本提案涉及与制造业有关的技术援助，包括工业生产设备， 根据公认的质量标准，确保一致和受控的规模扩大生产所必需的方法。 上述目标的实现将使Trace-Ability能够支持所有癌症PET药物制造商， 提供全自动QC解决方案。这将最大限度地发挥Tracer-QC业务的商业潜力 这依赖于不断增长的安装基础带来的经常性套件收入。在肿瘤学领域的影响将得到体现 FDG和其他癌症PET扫描的可用性增加，并促进新示踪剂的开发。这样的可用性 目前受到PET药物QC中的通量和合规性问题的限制，Tracer-QC已被证明可以解决这些问题 成功，但需要可扩展的套件生产，以提供整个行业的有利条件。

CRP Technical assistance is intended to accomplish the following for Tracer-QC product under development. It will establish industrial production methods (specifically high-precision injection molding) necessary to ensure consistent and controlled scale-up manufacturing of Tracer-QC analysis plates that are currently manufactured by non-salable, variable and costly machining process. CRP Problem. Trace-Ability is focusing a lot of current effort on scaling up Tracer-QC kit production to the levels that can supply the entire PET industry with high-quality kits. However, there is one aspect where the current manufacturing technology is not scalable and carries quality risks. It needs to be replaced by a completely new technology in order to support the PET industry. Specifically, it is the manufacturing of the core Tracer-QC analysis plate in which all QC assessments take place. Current plates are made by cutting standard 384-well plates. Such process is not scalable. It has inherent plate-to-plate variability and a high risk of debris contaminating the wells required for precise optical analysis. CRP Solution. Trace-Ability has developed a proposal together with Agilent Technologies, Inc. to manufacture analysis plates by injection molding. This project is designed to establish scalable production of analysis plates and re- validate all existing Tracer-QC assays in these plates. Specific Aim 1: Scalable injection molding process for manufacturing high-quality analysis plates. The “high-quality” acceptance criteria are (a) well absorbance <0.065 AU in the range of 400-700 nm with a standard deviation (b) <0.003 AU in empty wells and (c) <1% in filled wells at 500 nm. Development will be performed by Agilent. Milestones: (a) Molded plates meet all acceptance criteria. (b) Finalized molding process is suitable for over 200,000 plates per year. Specific Aim 2: Tracer-QC tests validated successfully in molded plates. Before the new plates can be included in Tracer-QC kits that can be used for release testing of FDG and other PET drugs, 8 assays that rely on the wells of the plate will require testing and validation: color, clarity, pH, Endotoxin, Kryptofix, acetonitrile, ethanol and radioactivity concentration. Proposed work will be carried out at Trace-Ability. Milestone: Validation results meet all ICH Q2 (R1) acceptance criteria for all assays. This proposal is for technical assistance associated with manufacturing, including industrial production equipment and methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards. Achievement of the above aims will put Trace-Ability in position to support all manufacturers of cancer PET drugs in their full capacity with a fully-automated QC solution. This will maximize the commercial potential of the Tracer-QC business that relies on recurring kit revenues from the growing install base. The impact in the field of Oncology will be manifested in increased availability of FDG and other cancer PET scans and facilitation of new tracer development. Such availability is currently limited by throughput and compliance issues in PET drug QC, which Tracer-QC has proven to address successfully, but needs scalable kit production to offer the enabling benefits to the entire industry.