Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers.

Most recent advances in the management of AD call for extensive use of Positron Emission Tomography (PET) imaging in order to maximize patient benefits, as reflected in Draft NIA-AA Revised Clinical Guidelines for Alzheimer’s and multiple analyses of current and upcoming therapies. However, availability of AD PET across the country is severely limited by the capacity of the manufacturers of short-lived radioactive contrast agents – AD PET tracers. Technology developed in current NIA Phase II project (R44AG071409) enables dramatic expansion of AD PET imaging by substantially simplifying and standardizing the commercial production process for AD PET tracers. The most complex and currently non-scalable part of the PET tracer production process is Quality Control (QC). Trace-Ability has pioneered a radically new approach (Tracer-QC), where most of the QC tests are based on optical measurements enabled by disposable kits containing Trace-Ability’s innovative indicators. Phase IIB project will take Tracer-QC technology with commercial reliability successfully achieved in current NIA Phase II at small scale to commercial robustness and scale required for its rapid nationwide implementation in production of AD PET tracers. Key requirements for this are (1) product shelf-life and (2) high-quality scale-up procedures for disposable kits, which define the project’s Specific Aims: Specific Aim 1: 12-Month stability established and proven for Tracer-QC kits. Continuous use of Tracer-QC in demanding commercial settings requires such stability, since any interruption in Tracer-QC operation may translate into patients not getting their AD PET scans. Specific Aim 2: Tracer-QC kit production scale-up procedures developed and validated within an ISO 9001:2015- certified Quality Management System (QMS). Achievement of this aim will involve: (1) Redesign of product and process to achieve consistent and controlled scale-up manufacturing. (2) Establishing and certifying an ISO 9001:2015 QMS. Outcomes. Successful completion of this project will expand availability of AD PET tracers across the country by simplifying AD PET tracer production procedures so that they can be implemented in any facility, even those constrained in space and skill sets. Superior quality of AD PET tracers released by robust and standardized Tracer-QC platform will further steer both customers and regulators to make it the preferred solution. By effecting the largest number of commercial production sites in a single standardized effort, this project enables rapid expansion of AD PET imaging to the broad AD population, that cannot easily travel. With the US AD population over 5 million and cost of treatment over $320B/year, there is strong need for AD PET in clinical trials to optimize their efficacy. Also, recently approved therapeutics are expected to lead to a 20-fold increase in AD PET imaging. All of these events drive immediate need for a paradigm shift technology to enable AD PET tracer manufacturers to support nationwide demand for AD PET imaging. Fortunately, Tracer-QC technology can address this once the aims of this project are achieved.