{"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":["ga-68","tc-99m","mo-99","ge-68"],"indications":[],"sections":[],"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":{"isotope":[{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"},{"id":"ge-68","kind":"isotope","name":"Germanium-68","route":"/isotopes/ge-68/"},{"id":"kr-81m","kind":"isotope","name":"Krypton-81m","route":"/isotopes/kr-81m/"},{"id":"mo-99","kind":"isotope","name":"Molybdenum-99","route":"/isotopes/mo-99/"},{"id":"re-188","kind":"isotope","name":"Rhenium-188","route":"/isotopes/re-188/"},{"id":"rb-82","kind":"isotope","name":"Rubidium-82","route":"/isotopes/rb-82/"},{"id":"tc-99m","kind":"isotope","name":"Technetium-99m","route":"/isotopes/tc-99m/"}],"technology":[{"id":"cold-kit-formulation","kind":"technology","name":"Cold kit formulation","route":"/technologies/cold-kit-formulation/"},{"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":"ge68-ga68-generators","kind":"technology","name":"Germanium-68/gallium-68 generators","route":"/technologies/ge68-ga68-generators/"},{"id":"medical-cyclotrons-synthesis-modules","kind":"technology","name":"Medical cyclotrons, hot cells, and synthesis modules","route":"/technologies/medical-cyclotrons-synthesis-modules/"},{"id":"mo99-tc99m-generators","kind":"technology","name":"Molybdenum-99/technetium-99m generators","route":"/technologies/mo99-tc99m-generators/"},{"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":"hta-atom-hi-tech","kind":"company","name":"HTA (Atom Hi-Tech)","route":"/companies/hta-atom-hi-tech/"},{"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":"oncobeta","kind":"company","name":"OncoBeta","route":"/companies/oncobeta/"},{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}],"drug":[{"id":"tc-99m-mdp","kind":"drug","name":"Technetium Tc-99m medronate (MDP)","route":"/drugs/tc-99m-mdp/"}],"bottleneck":[{"id":"b-mo99-supply","kind":"bottleneck","name":"Molybdenum-99 supply","route":"/bottlenecks/b-mo99-supply/"}],"section":[{"id":"f-radiochemistry","kind":"section","name":"Radiochemistry & manufacturing","route":"/fronts/f-radiochemistry/"}],"term":[{"id":"chelator-term","kind":"term","name":"Chelator (bifunctional chelating agent)","route":"/terms/chelator-term/"},{"id":"hot-lab","kind":"term","name":"Hot lab (radiopharmacy dispensing area)","route":"/terms/hot-lab/"},{"id":"radionuclidic-purity","kind":"term","name":"Radionuclidic purity","route":"/terms/radionuclidic-purity/"}]}}