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

CRP技术援助旨在为正在开发的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)，以确保一致性 以及受控放大制造示踪器-QC分析板，这些分析板目前由不可销售的、可变的 和昂贵的机械加工工艺。 C反应蛋白问题。Tracer-Capability将目前的大量工作集中在将Tracer-QC套件的生产扩大到 这可以为整个聚酯行业提供高质量的试剂盒。然而，目前的制造业有一个方面 技术是不可扩展的，并带有质量风险。它需要被一种全新的技术取代，以便 扶持聚酯产业。具体地说，它是制造的核心示踪器-QC分析板，其中所有的QC 进行评估。目前的板材是通过切割标准的384孔板制成的。这样的流程是不可扩展的。它有 板与板之间固有的可变性和碎片污染井的高风险，这是精确光学分析所需的。 C反应蛋白溶液。TraceCapability与安捷伦技术公司共同制定了一项提案，以制造 对板材进行注塑分析。该项目旨在建立可扩展的分析板生产并重新 验证这些试板中所有现有的示踪剂-质控分析。 具体目标1：用于制造高质量分析板的可伸缩注射成型工艺。“高品质” 验收标准是：(A)良好的吸光度&0.065 AU，范围为400-700 nm，标准偏差为0.003 AU。 在空井和(C)&lt；1%在500 nm的填充井。开发将由安捷伦执行。里程碑：(A)模制 车牌符合所有验收标准。(B)最终成型工艺适合每年生产20多万块板材。 具体目标2：示踪剂质控测试在模压板材中得到成功验证。在新的车牌可以被包括在 可用于FDG和其他PET药物释放测试的示踪-QC试剂盒，依赖于板孔的8种分析 将需要测试和验证：颜色、透明度、pH、内毒素、克立普妥、乙腈、乙醇和放射性 集中精神。拟议的工作将在跟踪能力处进行。里程碑：验证结果满足所有ICH第二季度(R1) 所有化验的验收标准。 本提案用于与制造有关的技术援助，包括工业生产设备和 根据公认的质量标准，确保一致和受控的扩大生产所需的方法。 上述目标的实现将使跟踪能力处于支持所有癌症PET药物制造商的地位 全自动QC解决方案，满负荷运转。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体现出来 在FDG和其他癌症PET扫描的可用性增加和促进新示踪剂的开发方面。这样的可用性 目前受到PET药物QC的产量和合规性问题的限制，Tracer-QC已经证明可以解决这一问题 成功，但需要可扩展的套件生产，以向整个行业提供有利的好处。

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.