Somewhere in a laboratory, tucked away in its vessel, a small vial sits. However, this vial is special because it is emitting energy – potentially life-saving energy that is disappearing with every fleeting moment. This is not a scene from a thriller – it is the daily reality of radiopharmaceutical manufacturing, where life-saving cancer therapies are manufactured, tested, delivered, and administered while racing against the clock. From the executive boardrooms of pharma companies to academic research centers, one fact is becoming unmistakably clear: making radiopharmaceuticals is an inherently complex, high-stakes endeavor, and the industry is racing to manage the risks of these perishable therapies before the clock runs out.
The unique complexity of radiopharmaceutical manufacturing
Radiopharmaceuticals marry advanced science with drug development and manufacturing skillsets. Unlike traditional small-molecule or biologic drugs, these therapies involve radioactive isotopes that require specialized facilities, stringent quality procedures, safety protocols, and precise coordination. Every dose is produced under strict quality standards. Without these standards, potential errors can occur – errors that could cause significant harm to the patient. So manufacturers must maintain this high standard of quality amid time constraints and logistical intricacies.
Tips for Greater Healthcare Practice Success in 2025
Join us on February 26 at 3 pm ET, and we’ll dive into the key areas where practices are losing time and money and provide solutions to overcome them.
Key factors that set radiopharmaceutical production apart include:
● No room for delay – perishability – Radioactive components of these products decay rapidly, often giving the final product mere hours to a few days of shelf life. There is no warehouse of inventory to draw from – every batch is made just in time and shipped immediately, or it is lost.
● Complex logistics – Once produced, patient doses often travel vast distances with little time to spare; a flight delay or storm can render a shipment useless for the waiting patient. Teams need flawless coordination and real-time tracking to navigate these challenges.
● Specialized infrastructure and skills – From nuclear reactors to cyclotrons which create isotopes, to “hot cells” and shielded labs for assembly, radiopharmaceutical manufacturing infrastructure is highly specialized and expensive. Trained nuclear pharmacists, chemists, microbiologists, and radiation safety experts, to name a few, are required at every site.
● Accelerated timelines – Paradoxically, while handling such complexity, developers are under pressure to move fast. Some radiotherapies are reaching clinical approval in nearly half the time of traditional drugs, forcing companies to build manufacturing capacity much earlier. This compressed timeline means taking on manufacturing scale-up risks far sooner than most biotech ventures would for other therapies.
All these factors create a perfect storm of risk and complexity. In conventional pharma manufacturing, a production hiccup may be costly; in radiopharma, it can be catastrophic – an entire day’s product can vanish due to decay or expiration if even a minor transport delay occurs. Recent real-world events have underscored this vulnerability: supply chain stumbles with Novartis’s Lutathera and Pluvicto radiotherapies led to temporary supply halts, shaking physician confidence and illustrating how even established operations can falter. The fallout was not just felt operationally; patient care was disrupted, doctors grew wary of prescribing, and the commercial momentum of those drugs wavered.
Perishable therapies and the cost of failure
The Funding Model for Cancer Innovation is Broken — We Can Fix It
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
For pharma executives, these challenges translate into a key insight: if you cannot reliably make and deliver the product, you effectively have no product. A cancer therapy that cannot reach patients in time is as good as ineffective, no matter how phenomenal its clinical effectiveness. Therefore, mitigating manufacturing and distribution risk is not a back-end technical detail – it is central to the therapy’s success and value. Industry experts emphasize planning for redundancy and robust supply networks at an early stage, far earlier than for traditional drugs, to ensure that as demand scales, supply can keep pace. Long-term planning and heavy investment in manufacturing infrastructure are now recognized as mission-critical to radiopharmaceutical commercialization.
The perishability factor means companies must orchestrate every step from isotope production to manufacturing and release testing, to patient infusion with flawless timing. There is no buffer in this system – no stockpile to smooth out disruptions. This urgency puts tremendous strain on in-house teams. A biotech developing a radiotherapy in-house might suddenly find itself in the distribution business, needing expertise in cold-chain logistics, regulatory approvals for radioactive shipping, and contingency plans for unexpected delays. It’s a burden few drug developers are prepared to shoulder on their own.
Overcoming the high-stakes in radiopharmaceuticals
In the dramatic, high-stakes world of radiopharmaceuticals, complexity is a given – but it can be managed. The key takeaway for biotech executives and academics is that acknowledging the unique challenges of radiopharmaceutical manufacturing is the first step toward overcoming them. The next steps involve strategic decisions: investing early in robust manufacturing plans, choosing the right partners, and designing a supply chain with as much care as the drug’s molecular design.
Image: DrAfter123, Getty Images
As Chief Commercial Officer at Nucleus RadioPharma, Kathy Spencer-Pike brings over 20 years of experience in Fortune 50 companies and fast-growing startups. Before joining Nucleus RadioPharma, she was Chief Sales Officer at McKesson. Previously, as VP, Commercial Leader at Novo Nordisk, she led market and sales strategies and also held leadership roles at Sanofi and Pfizer, managing sales, marketing, and operations. Kathy holds a B.S. in Elementary Education from Eastern Kentucky University and an M.A. in Mental Health Counseling from Webster University.
This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.