Radiopharmaceutical GMP and releasing a drug that decays
A radioactive medicine loses activity every hour, so it is made to order, tested in hours and often injected before the sterility test has finished. The rules for that are different from ordinary drugs, and the handful of plants that make lutetium therapies have had their own shortages.
Overview
Radiopharmaceuticals are made under GMP frameworks written for their half-lives: 21 CFR 212 for PET drugs in the United States (with USP chapters 823 and 825 for compounding and nuclear pharmacy), 21 CFR 211 for therapeutic radiopharmaceuticals, and EU GMP Annex 3. Each batch is calibrated to a stated activity at a stated time, tested for radionuclidic purity (for example lutetium-177m in carrier-added lutetium-177), radiochemical purity (how much of the isotope is actually attached to the ligand), pH, endotoxin and appearance, and released within hours; the regulations allow release before the fourteen-day sterility test is complete because the product would otherwise have decayed, with the test finished retrospectively. Shelf life is measured in hours for PET tracers and a few days for lutetium products, so manufacture is scheduled against a named patient's appointment and the dose is shipped in a shielded container the same day.
Therapeutic radioligands are made centrally. Novartis produces lutetium-177 dotatate and lutetium-177 vipivotide tetraxetan at plants in Millburn and Indianapolis in the United States, Zaragoza in Spain and Ivrea in Italy, and in 2022 paused Ivrea and Millburn over potential quality issues, then in 2023 limited new patient starts in the United States until the Indianapolis site was licensed and lutetium supply caught up. Curium, ITM, Telix and Lantheus run or contract their own radiopharmaceutical plants and radiopharmacy networks. Because any delay means a missed treatment rather than a late shipment, the sector has argued for regional radiopharmacy hubs and harmonised transport rules, ideas recorded elsewhere on this site.
- PSMA / SSTR-positive cell
How it works
Time-stamped activity, rapid quality control and conditional release before sterility results, under GMP annexes written for half-lives of hours to days.
- Clear regulatory frameworks in the US and EU
- Quality control fits within the half-life
- Central plants give consistent product
- Missed slots are lost doses
- Few licensed therapeutic plants
- Cross-border transport of radioactive material
Latest papers
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