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

This Small Business Innovation Research Phase I project will enable a disruptive technology that increases the efficiency and capacity of nuclear pharmacies that supply imaging tracers for Positron Emission Tomography (PET). PET represents the most powerful medical imaging modality, yet its availability is severely limited by the nuclear pharmacy throughput capacity. The proposed effort will remove this bottleneck and lead to a radical improvement in the availability of medical imaging with PET to the patients who depend on it for accurate diagnosis in oncology, cardiology and neurology. The number of PET scans is projected to grow from 7 to 19 million between 2013 and 2018. However, the current state of the nuclear pharmacy industry will not support such growth unless it switches from current manual methods for compliance checking and quality control. The goal of this project is to develop automated solutions for these cumbersome and expensive tasks. The demand for this new product is already apparent and the addressable market is estimated at $500 million. Once the proposed technology is proven in the nuclear pharmacy industry, it is envisioned that the same platform will find applications in other industries that require regular multi-parametric testing (e.g. wastewater or food inspection). The intellectual merit of this project is in the development of two innovative analytical methods that can be implemented using a commercial plate reader. The first one is a radioactivity measurement using Liquid Scintillation Counting (LSC). This project will enable LSC in a plate reader operating in luminescence reading mode. In this effort, the radioactive sample will be mixed with scintillating material and is expected to produce a quantifiable luminescence signal. The second test is quantification of a cryptand commonly used in the synthesis of PET imaging tracers. The plan is to develop a colorimetric indicator that allows quantification of this cryptand by measuring the absorbance of color resulting from the binding of cryptand with indicator in a plate reader. These tests are the two critical components that need to be proven in order to demonstrate complete, automated quality control (QC) of a short-lived radiopharmaceutical product with a single plate reader, and without any contact between the reader and the sample. Currently, this same QC process requires 10 to 14 manual tests done using multiple instruments, most of which come in contact with the sample and need to be cleaned and equilibrated.