Benchtop Radiochemistry System for On-Demand PET Probe Synthesis
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Solution Overview
Problem
The limited accessibility and high costs associated with producing a diverse range of Positron Emission Tomography (PET) probes due to the need for specialized infrastructure and expertise, restricting their use in research and clinical settings.
Innovation Solution
A decentralized, automated bench-top radiochemistry system that integrates microfluidics for chemical synthesis, purification, and quality control, allowing for on-demand production of PET probes using a compact, self-shielded device with a supply of radioisotopes and one-use reagents, eliminating the need for hot cells and reducing radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If centralized radiopharmacies with cyclotrons and hot cells are used for PET probe production, then production capability and probe diversity are improved, but infrastructure cost and operational complexity increase significantly
Solution Approach 1:
The system divides the PET probe production process into modular functional units: a cyclotron for isotope production, automated synthesis modules for chemical synthesis, and purification systems. Each module operates independently and can be controlled separately, allowing complex probe production to be achieved through coordination of simpler, specialized components rather than requiring a monolithic hot cell facility
Solution Approach 2:
The patent introduces automated synthesis robots and pre-prepared reagent kits as intermediaries between the cyclotron and final probe formulation. These intermediaries handle the hazardous synthesis operations automatically, eliminating the need for manual hot cell operations while maintaining production capability and probe diversity
2Productivity
If centralized radiopharmacies with hot cells are used for PET probe production, then production capability is improved, but radiation exposure risk and safety requirements worsen
Solution Approach 1:
The patent extracts the hazardous synthesis operations from manual hot cell environments and transfers them to automated robotic systems that operate in shielded or remotely controlled environments. The synthesis robot performs all wet chemistry operations automatically, eliminating human presence in high-radiation zones while maintaining production capability
Solution Approach 2:
The automated synthesis system is designed to perform all operations autonomously without human intervention during the synthesis process. The system automatically handles reagent dispensing, reaction monitoring, and product purification, reducing the need for personnel to work in or near radiation fields while maintaining high productivity
3Reliability
If commercial radiopharmacies produce PET probes centrally, then quality control is improved, but accessibility and availability to research institutions worsen
Solution Approach 1:
The patent enables research institutions to copy the automated synthesis system and associated software protocols from commercial radiopharmacies. By licensing the automated synthesis technology and standardized procedures to academic and research facilities, the system maintains quality control through replicated proven methods while dramatically improving accessibility and availability of diverse PET probes to research communities
Data Source
AI summary
A self-shielded, bench-top radiochemistry system, including a radioactive isotope dispensing module configured to draw an isotope out of a vial and dispense one or more metered doses of the isotope to a concentration module that concentrates the metered dose into a droplet amount of isotope and a synthesizer module that delivers the droplet amount of isotope along with one or more reagents to an electrowetting on dielectrics (EWOD) chip to produce a radiolabeled molecule.