Regional cyclotron hubs for actinium-225 with an agreed actinium-227 impurity limit
Actinium-225 can be made in particle accelerators, but the product contains a trace of a long-lived impurity that regulators have not agreed how to handle. Settle the limit and build the hubs.
Overview
Proton irradiation of radium-226 yields actinium-225 with a small admixture of actinium-227 (half-life 21.8 years), while electron linac photonuclear and high-energy spallation routes differ in impurity profile. Without a harmonised monograph, each producer negotiates specifications with each regulator, slowing investment. The proposal is a joint European, US and Japanese pharmacopoeia monograph setting actinium-227 and other radionuclidic impurity limits based on dosimetry and waste handling, paired with public co-investment in three to five regional cyclotron or linac hubs sized for clinical supply.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
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