Dual HPLC-TLC Platform for Enhanced Quality Control of Alpha-Emitting Radiotherapeutics

Background & Unmet Need

• Radiopharmaceuticals using alpha-emitting isotopes like Ac-225 are emerging as powerful therapeutic tools for treating cancer
• Current quality control methods using radioHPLC or radioTLC alone cannot accurately assess the purity of complex alpha-emitting compounds
• Rapid, accurate purity verification is critical for patient safety and regulatory compliance in radiopharmaceutical production
• Manual handling of radioactive samples increases personnel exposure risks
• Unmet Need: A standardized method of accurate and rapid quality control analysis of complex radiopharmaceuticals that does not compromise analytical precision and minimizes radiation exposure

Technology Overview

• The Technology: An integrated HPLC-radioTLC analysis platform for precise radiopharmaceutical quality control
• The platform features a chemically resistant moving stage with protective cover, compatible with multiple radioTLC scanner models
• The system uses disposable inserts with absorption-lined wells to prevent cross-contamination
• PoC Data: A working prototype has been validated across multiple radionuclides (225Ac and 134Ce) and diverse radiopharmaceutical types including small molecules, peptides, antibodies, and nanoparticles.
• The platform demonstrates rapid analysis times (~30 minutes) while maintaining robust analytical integrity

Technology Applications

• Quality control analysis in GMP radiopharmaceutical manufacturing
• Clinical radiopharmacy operations requiring standardized QC procedures
• Analysis of novel radiotherapeutics in research settings

Technology Advantages

• Enables precise identification of radiolabeled compounds and their impurities
• Reduces operator radiation exposure through improved handling design
• Compatible with existing radioTLC equipment through versatile stage design
• Accommodates both manual and automated fraction collection methods

Figure: Prototype of the integrated HPLCradioTLC platform showing the 3D-printed customizable moving stage with disposable insert installed in a commercial radioTLC scanner.