As demand for life-extending radiotherapies grows, organizations must look beyond clinical development and ask a crucial question: Can we make this at scale without compromising quality or speed?
Unlike traditional drug development, where scale-up may happen gradually over time, radiopharmaceuticals require readiness far earlier in the process. That’s because these therapies, which are often fast-tracked through clinical approval, combine biological complexity with radioactive components that degrade rapidly. You can’t stockpile doses or wait for the right moment to build out manufacturing.
Scalability, then, becomes a foundational pillar—not a nice-to-have. It’s a challenge baked into every clinical milestone.
What makes scaling so difficult?
What sets radiopharmaceutical manufacturing apart is not just the need to scale; it’s the conditions under which that scale must happen.
The urgency starts with the product itself. Most radiotherapeutics rely on isotopes that begin to degrade almost immediately after production, giving the final product a shelf life that’s often measured in hours, not days. That perishability means there’s no option to stockpile inventory or pad the schedule. Every step—from isotope production and synthesis to quality testing, packaging, and delivery—has to be executed with near-perfect precision.
Layered on top of that is a highly sensitive logistics chain. Without the luxury of inventory buffers, patient doses must be shipped just in time. Often, that means traveling long distances under strict temperature and radiation safety protocols. A flight delay, a snowstorm, or even a paperwork holdup can render a shipment unusable, with real consequences for patient care and provider confidence.
None of this is possible without the proper infrastructure in place. Radiopharmaceutical manufacturing doesn’t happen in a standard cleanroom, it requires specialized assets like cyclotrons for isotope production, hot cells for safe handling, and heavily shielded labs to protect personnel and product integrity.
Beyond the physical space, it takes a team of highly trained experts: nuclear pharmacists, radiochemists, microbiologists, radiation safety officers, and quality professionals, all working in lockstep.
Planning for scale starts earlier than you think
The consequences of failing to scale effectively are far-reaching. Even minor supply disruptions can derail a therapy’s momentum. Given the complexity, radiopharmaceutical companies must consider scalability long before reaching commercial stages.
- Building or finding the proper infrastructure early. Not just lab space, but a facility footprint that can grow with you. Whether you’re in R&D or preparing for your commercial launch, having space to scale without moving operations can save critical time.
- Designing with flexibility in mind. Your manufacturing systems must adapt as your therapy evolves. A facility that can support both clinical batches and commercial volumes under one roof enables faster transitions and fewer disruptions. The ability to house R&D and manufacturing in one location enables better collaboration, faster tech transfer, and fewer handoffs that could slow progress or introduce errors.
- Planning for supply chain complexity. With ultra-short shelf lives and strict handling requirements, radiopharmaceuticals demand a reliable logistics network. Real-time tracking, decay-adjusted dosing, and secure cold-chain delivery are essential for getting the right dose to the right patient at the right time.
- Prioritizing partnerships. Most organizations can’t scale alone. Strategic partners with the right technical expertise, purpose-built facilities, and proven processes can significantly de-risk your scale-up process.
Scalability is the backbone of long-term success
In radiopharma, it’s not enough to have a groundbreaking therapy. The true measure of success is whether you can deliver that therapy reliably, consistently, and at scale. That means building systems that can support growing demand without compromising quality, safety, or speed.
Scalability isn’t something to consider after approaching clinical milestones—it needs to be part of the foundation from the start. Whether it’s the infrastructure to manufacture at higher volumes, the supply chain to deliver doses on time, or the operational flexibility to respond to evolving needs, your ability to scale determines how far your therapy can go.
At Nucleus RadioPharma, we’ve built our end-to-end CDMO model with this reality in mind. From early development to commercial-scale production, we support companies with the infrastructure, expertise, and flexibility needed to meet today’s challenges and tomorrow’s opportunities.
If you’re developing a radiotherapeutic and thinking about how to scale, we’re here to help.