When Drug Supply Has A Half-Life: Radiopharmaceutical Logistics

A conversation With Fredrik Frejd, Chief Scientific Officer, Affibody

Transporting radiotherapy drugs is like transporting melting ice cubes, Fredrik Frejd, chief scientific officer at Swedish biotech Affibody, told Clinical Supply Leader. “It has to arrive at the perfect size, so you need to calculate how much it melts during transportation.”

Indeed, a patient will need an exact amount of drug, so creating a logistics plan means working backward from the date and time the patient is due to be dosed, all the way to sourcing the radionuclide and coordinating each production and delivery step along the way.

“This whole logistics chain means that the patient needs to be at the site at that specific time point,” said Frejd. “Just having that is a bottleneck. Making sure the patients come and that they, for example, are not sick, is a challenge. Otherwise, the whole ordering of this very expensive drug – the radioactivity is also super expensive – is wasted because the patient did not show up.”

That makes patient scheduling part of the supply chain itself. Unlike a conventional drug that can be held in inventory for another patient or another day, a radiopharmaceutical has a very narrow window in which it can be used.

Frejd, who has over 25 years of experience in life sciences research looking at tumor-targeted substances, describes decay profiles as “absolutely crucial” when it comes to logistics. When the half-life is short, the radionuclide must be generated at a purpose-built site close to the hospital, potentially improving delivery times but creating more manufacturing sites that need to be managed and monitored.

“For actinium, with a 10-day half-life, it's easy,” he said. “You could have one central manufacturing site globally, or one in America, one in Europe, and one in Asia, for example, and just ship all over the globe with that. So that creates really different types of logistics.”

For clinical supply teams, that can affect everything from site selection and manufacturing strategy to how much flexibility can be built into the dosing schedule. A short half-life leaves little room to absorb delays, so the supply chain has to be designed around the patient’s dosing window rather than around conventional inventory models.

Decay profiles are not the only factors that need to be accounted for. Measurement cameras, which are used at clinical trial sites to image where the radioactivity is distributed in a patient and calculate the radiation dose delivered to different organs, must be calibrated to ensure that the same measurements are produced across sites. This is important so that dosimetry data can be reliably compared between patients, Frejd said.

“Another problem is the availability of the nuclides. It has been much improved now for lutetium, but it's still a challenge for actinium,” he went on. “The scarcity of actinium is actually hampering a lot of businesses, or the industry, from doing clinical trials and research.”

Ac-225 is particularly challenging to produce at the required level of purity because production can generate hundreds of co-produced radionuclides, including the long-lived radioactive contaminant Ac-227, which must be efficiently separated from the Ac-225. A 2024 paper estimated that global Ac-225 production was around 63 GBq/year, compared with estimated clinical demand of about 185 GBq/year.

“There is also the issue of how to move radioactive drugs across borders. It's still a very scattered regulatory scene for radioactivity,” said Frejd. “Different countries have different views of what is needed and what is not needed. The regulatory framework is not as mature for radiopharmaceuticals as it is for other drugs. So, there are a lot of such challenges that add to the complexity of having clinical trials in this area.”

A 2025 European Commission-backed survey of 40 countries found differences in how Euratom pharmaceutical and radiation protection rules are interpreted and applied, with respondents identifying the regulatory disconnect as a barrier to the development and patient access of innovative radiotherapeutics.

The crux of the challenge, then, may be less about solving any single logistical bottleneck than about deciding how specialized radiopharmaceutical medicine can become without limiting who can benefit from it.

A standardized dosing approach is quicker and easier to deploy across trial sites, potentially widening recruitment and fitting more readily within existing regulatory frameworks. But a personalized approach, informed by patient-specific dosimetry, could generate richer data and allow developers to optimize treatment more precisely, potentially opening the door to more effective and innovative radiotherapeutics.

The question, according to Frejd, is whether the field can develop the infrastructure and regulatory flexibility to pursue that potential without making these treatments accessible only to the most specialized centers. “It’s a delicate balance of robustness of data versus speed of the trial and, hence, development speed,” he said.

About The Expert:

Fredrik Frejd is the chief scientific officer at Affibody and has over 25 years of experience in life sciences research with particular expertise in biologics drug development, phage display and therapeutic protein engineering of alternative scaffolds. He received his Ph.D. from the Swiss Federal Institute of technology, ETH, in Zurich in 2001 and joined Affibody AB in 2002. Frejd is also an adjunct professor in cancer precision medicine at the department for Immunology, Genetics and Pathology at Uppsala University, with a special focus on development of tumor targeting agents for molecular radiotherapy.