18F-flotufolastat (previously known as 18F rhPSMA-7.3)

Automated labeling of flotufolastat gallium triflutate with ¹⁸F on the IBA Synthera^®+ Platform - a simplified and efficient approach

Flotufolastat (previously known as ¹⁸F rhPSMA-7.3) developed by Blue Earth Diagnostics stands out as a promising theranostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) receptor. Diagnostic ¹⁸F-flotufolastat enables high-resolution PET imaging of PSMA-expressing lesions. Its favorable positron energy and longer half-life (109.8 minutes – comparing to ⁶⁸Ga-labeled compounds) enhance image quality and sensitivity.
Approved by the FDA for commercial use.
It can also be labeled with therapeutic radiometals (such as ¹⁷⁷Lu and ²²⁵Ac) for targeted radiotherapy. The dual-labeling capability opens avenues for targeted radiotherapy, potentially improving treatment outcomes.

Results

Five high activity (around 4 Ci – 148 GBq) runs showed repeatable outcome with n.d.c. (non-decay corrected) yield of 62.4±1.4%. From receiving radioactivity to a ready product, the process takes only 20 minutes, and the final product obtained was all compliant with the requirements of quality control.

Quality control

Stability tests, conducted at 2, 3, and 6 hours post-synthesis using both HPLC and TLC methods, confirmed that the compound remained stable in its final formulation throughout the tested period, ensuring its viability for clinical application.

 DISCLAIMER: ¹⁸F-flotufolastat is approved in the United States by the FDA and is not currently approved in other jurisdictions. This is a proprietary tracer. To access it, users must obtain authorization from Blue Earth Diagnostics Ltd.