{"entity":{"id":"radionuclide-generators-kits","kind":"technology","name":"Radionuclide generators and cold kits","aka":[],"tldr":"Bench-top devices that 'milk' a short-lived isotope from a long-lived parent, plus vials of ready-to-label ligand. How most hospitals make PSMA and somatostatin PET tracers without a cyclotron.","summary":"Ge-68/Ga-68 generators (Eckert & Ziegler GalliaPharm, IRE ELiT Galli Eo, ITG) elute Ga-68 for 6-12 months; Mo-99/Tc-99m generators (Curium, Lantheus, GE) underpin SPECT; kits such as Illuccix and Gozellix (Telix), Locametz (Novartis) and NETSPOT (Novartis/AAA) let a radiopharmacy label PSMA-11 or DOTATATE in minutes. Generator supply shortages (Ge-68 in 2018-19) and kit versus unit-dose economics shape tracer access.","status":"standard-of-care","asOf":"2026-09-08","links":[{"label":"21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["radiopharma"],"technologies":["psma-pet","pet-tracer-manufacturing","medical-cyclotrons-synthesis-modules","spect"],"targets":[],"drugs":[],"companies":["eckert-ziegler","curium","telix","novartis","lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Parent isotope adsorbed on a column decays to the daughter, which is eluted on demand; cold kits contain lyophilised chelator-ligand and buffer for one-step labelling.","strengths":["Cyclotron-free access to PET tracers","Decentralised, low-cost labelling"],"limitations":["Limited activity per elution (few patients per day)","Generator supply concentrated in a few producers","Regulatory status of kits varies by country"]},"route":"/technologies/radionuclide-generators-kits/","neighbours":{"section":[{"id":"radiopharma","kind":"section","name":"Radiopharmaceuticals & Theranostics","route":"/fronts/radiopharma/"}],"technology":[{"id":"cyclotron-isotope-production","kind":"technology","name":"Cyclotron isotope production (F-18, Ga-68, Cu-64, Zr-89, At-211)","route":"/technologies/cyclotron-isotope-production/"},{"id":"medical-cyclotrons-synthesis-modules","kind":"technology","name":"Medical cyclotrons, hot cells, and synthesis modules","route":"/technologies/medical-cyclotrons-synthesis-modules/"},{"id":"pet-tracer-manufacturing","kind":"technology","name":"PET tracer manufacturing and distribution","route":"/technologies/pet-tracer-manufacturing/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"research-reactor-isotope-production","kind":"technology","name":"Research reactors for medical isotopes (Mo-99, Lu-177, I-131)","route":"/technologies/research-reactor-isotope-production/"},{"id":"sstr-pet","kind":"technology","name":"Somatostatin receptor PET (68Ga/64Cu-DOTATATE)","route":"/technologies/sstr-pet/"},{"id":"spect","kind":"technology","name":"SPECT & bone scan","route":"/technologies/spect/"}],"company":[{"id":"curium","kind":"company","name":"Curium","route":"/companies/curium/"},{"id":"eckert-ziegler","kind":"company","name":"Eckert & Ziegler","route":"/companies/eckert-ziegler/"},{"id":"ire","kind":"company","name":"IRE (Institut national des Radioéléments)","route":"/companies/ire/"},{"id":"lantheus","kind":"company","name":"Lantheus","route":"/companies/lantheus/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}]}}