With new isotopes entering clinical trials and therapies showing promise across oncology, the pipeline for radiopharmaceuticals is expanding.
Yet even as science accelerates, supply chain vulnerabilities remain one of the biggest threats to program success. A shortage, a regulatory delay, or a disruption at a single supplier can reverberate across the development pipeline, stalling innovation and delaying patient treatment availability.
Why supply chain diversity matters
Radiopharmaceuticals are unique in their reliance on isotopes, which are both technically complex to produce and highly time-sensitive due to their short half-lives. This creates natural points of fragility in the supply chain.
When developers depend on a single isotope supplier, they face what supply chain experts call a single point of failure. If that supplier experiences production issues, can’t secure raw materials, or is impacted by geopolitical disruptions, the effect cascades quickly. Clinical trial enrollment can grind to a halt, and patient access to therapy is delayed.
Industry history offers examples of promising programs forced to pause due to isotope scarcity. One of the most notable was in 2023, when a major clinical trial had to suspend enrollment because actinium-225 became globally scarce. Similar challenges have occurred with lutetium-177, where production bottlenecks limited availability just as demand surged.
These shortages don’t just slow a single study; they ripple across the ecosystem, delaying patient access, straining budgets, and creating uncertainty.
By contrast, a diversified supply chain reduces this risk. Partnering with multiple suppliers across geographies and ensuring more than one qualified source for critical materials means programs can continue uninterrupted even if one node in the chain is stressed.
The strategic advantages of diversification
Diversifying isotope and supplier relationships isn’t just a safeguard against disruption; it creates clear strategic advantages for radiopharma developers.
When redundancy is built into their supply chains, developers can move forward knowing that a single vendor’s challenges won’t derail a trial. That reliability translates into confidence for teams, investors, and ultimately patients.
Flexibility is another benefit. In early development, programs sometimes pivot, whether because of new clinical data, evolving strategy, or supply constraints. Having access to multiple isotopes and suppliers allows innovators to adapt without losing time or momentum. As therapies advance toward commercialization, that same diversity supports scale-up, making it easier to expand into new geographies, adjust manufacturing models from centralized to regional, and meet increasingly rigorous regulatory requirements.
Perhaps most importantly, a diversified model creates resilience under pressure. The pharmaceutical industry has seen how quickly markets can shift from sudden raw material shortages to global events like the COVID-19 pandemic. Developers who had already invested in diversified supply networks were able to weather those challenges far more smoothly than those tied to a single point of failure.
Supplier evolution and what it means for CDMO selection
The push for diversification is being echoed in the supplier landscape itself.
Historically, isotope vendors specialized in producing just one or two isotopes. Today, new investment in production infrastructure is changing that model. Suppliers are expanding their portfolios, offering multiple isotopes from the same facility.
For developers, this shift means that fewer supplier relationships can now provide access to a broader range of isotopes while still maintaining redundancy and avoiding single points of failure. The result is a more resilient and efficient supply chain, provided their CDMO partner has the infrastructure and expertise to support it.
For innovators evaluating CDMOs, supply chain resilience should be a central consideration. A strong partner demonstrates this in a few key ways:
- Isotope-agnostic capabilities that support a wide range of isotopes safely and compliantly.
- Redundant supplier agreements across geographies for isotopes and critical consumables.
- Built-in scalability from preclinical studies through commercial production.
- Ongoing vendor management to ensure quality, performance, and compliance over time.
Choosing a CDMO with these capabilities gives developers more than a production partner; it provides a safeguard against uncertainty and a strategic ally for long-term growth.
Nucleus RadioPharma’s isotope-agnostic model
Every therapy is different, and so are the isotopes behind them. That’s why we’ve invested in an isotope-agnostic model and designed our facilities, processes, and supply agreements to accommodate whichever isotope our clients are working with.
This means we’re equipped to work with today’s leading therapeutic isotopes, including actinium-225, lutetium-177, copper-67, and lead-212, while staying ready for the next generation of isotopes as they move from research into clinical development.
Our supply agreements span multiple geographies to reduce risk, and our facilities in Rochester, Philadelphia, and Phoenix are built to support clinical and commercial production. Even our logistics and packaging systems are engineered with flexibility in mind, ensuring safe, compliant delivery regardless of isotope.
Want to talk supply chain resilience for your radiotherapy? Let’s chat about how our facilities, expertise, and processes can support your program.