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