At TPU, lutetium-177 is produced with a carrier-free technology. It is produced not from stable lutetium-176, but from stable ytterbium-176 (a rare-earth metal). This technology makes the isotope free from impurities of other isotopes of lutetium: any impurities limit its therapeutic effect, while the pure drug can easily bind to any molecules, killing the tumor, reducing the negative effects of radiation on healthy cells and having no toxic effect from the carrier in the form of stable lutetium-176, which is always present in the drug derived from lutetium-176.
A sealed capsule made of ytterbium-176 oxide is irradiated in the nuclear reactor for a week, where ytterbium-176 converts to ytterbium-177, which in its turn generates lutetium-177. Then the capsule is transferred to a new protective box where, using radiochemical methods, lutetium-177 is extracted from irradiated ytterbium-176. Tomsk Polytechnic University has its own unique technology of lutetium extraction, which excludes the use of hazardous substances such as mercury, and considerably reduces the processing time up to four days, which would facilitate the isotope production in large quantities.
At first, the TPU reactor plans to produce an active pharmaceutical substance. Then the clinics that use this isotope will produce a drug to be administered to patients based on the substance. Now, it is a PSMA molecule-based drug. This is a compound of an isotope and a protein sensitive to prostate-specific membrane antigen, which intensively accumulates in a tumor, affecting it with radioactive radiation from the isotope. The protein detects a cancer cell and lutetium destroys it. High-tech treatment of metastatic cancer with a lutetium-177-PSMA-based drug has been available at leading oncology clinics of the country, including the Tomsk NIMC Research Institute of Oncology, since 2021.The shielded box protects personnel from radiation and ensures safe operations with radioactive substances. The new box was purchased with the funds from the federal program. It would have been impossible to produce lutetium-177 isotope in the required volume without it, despite the available production technology. Commissioning of the protective boxes will kick-start the production as soon as they are installed in the clean room facilities along with the equipment designed and manufactured by TPU specialists. One cycle would give up to 100 doses of therapeutic isotope to treat the equivalent number of patients,
At the same time, they are gearing up for the production of a finished drug with not only PSMA molecule, but also a number of other proteins to treat a wide range of diseases. Chemists at Tomsk Polytechnic University are working on all these proteins, including PSMA.
As a result, it is planned to bring to the market a whole range of in-house lutetium preparations upon completion of the appropriate registration procedures with Roszdravnadzor. All of them can potentially be produced at the TPU reactor.
The cost of the lutetium-177-based pharmaceutical substance produced at the university's reactor would be comparable to that currently being used by physicians.