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

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.