Each phase of radiotherapy development brings its own technical, regulatory, and operational challenges. The requirements shift rapidly as you move from early-stage formulation to commercial manufacturing, and so must your approach.
Radiopharmaceutical development doesn’t follow the same rules as traditional pharma. The half-lives are shorter, the materials are harder to handle, and the logistics leave little room for error. Teams used to standard drug development often underestimate how much faster they need to make decisions and how tightly they must align operations to keep things moving. What works in a conventional setting can quickly fall apart when applied to radiotherapy.
Success in radiopharmaceuticals largely depends on identifying what’s required at each stage and planning accordingly. The earlier you define the proper infrastructure, processes, and partnerships, the fewer disruptions you’ll face later on.
To help you plan ahead, here’s what to expect—and what to ask—at each major stage of radiotherapy development.
Development and preclinical research
In the preclinical stage, foundational decisions about formulation, feasibility, and compliance are made that will impact every downstream phase. For radiotherapies, this means developing within a highly specialized environment from the start.
Facilities must be equipped to support safe, compliant development activities specific to radiopharmaceuticals, including shielding, contamination control, and radiation safety protocols tailored to early formulation and process development.
Establishing a dedicated R&D space, separate from manufacturing operations, can significantly streamline later transitions and reduce the risk of rework or scale-up delays.
Key considerations at this stage include:
- What infrastructure and expertise do I need to move from concept to scale?
- Does my R&D environment allow for safe and flexible formulation optimization?
- Are my processes being documented with eventual tech transfer in mind?
- Is my development strategy aligned with GMP requirements and regulatory expectations?
Clinical
Clinical-stage production for radiopharmaceuticals is often fast-tracked, leaving little margin for delays or inefficiencies. Dose accuracy, regulatory documentation, and supply chain planning all must happen in parallel and under strict time constraints.
Clinical trials don’t just test the therapy, they test your operational readiness. Establishing a compliant manufacturing environment, with regulatory-aligned documentation and flexible capacity, is essential for trial execution without bottlenecks.
Key considerations at this stage include:
- Can my operation support trial timelines, regulatory expectations, and production scale-up?
- Is my process tech-transferable, and does my team have a defined scale-up plan?
- Are my facilities validated and audit-ready to support GMP manufacturing for clinical use?
- Do I have a reliable plan for isotope sourcing and scheduling aligned with patient enrollment?
Commercialization
At commercialization, radiotherapy manufacturing becomes a race against time, radiation decay, and complexity.
Unlike traditional therapies, doses can’t be stockpiled and they must be manufactured and delivered just in time. That puts pressure on every part of your operation, especially your facility footprint and supply chain.
Radiopharmaceutical manufacturing requires more than cleanrooms; it demands hot cells, advanced shielding, and rapid quality testing capabilities. Facilities must be able to handle these unique requirements while maintaining GMP compliance at scale.
Key considerations at this stage include:
- Are my manufacturing systems built to scale without compromising quality?
- Do I have the infrastructure and workforce in place to meet volume requirements?
- Are my facilities located near treatment centers or distribution hubs to reduce transit time disruptions?
- Can my operation manage both ongoing clinical supply and commercial production without disruption?
Logistics and delivery
Even the best therapy falls short if it doesn’t reach the patient intact and on time.
Radiopharmaceutical logistics are shaped by short half-lives, strict regulatory constraints, and limited carrier options. That makes real-time coordination and decay-adjusted delivery essential.
FedEx remains the only major carrier for radioactive shipments in the U.S., and treatment centers often lack the infrastructure to handle delays. Without real-time tracking and decay-adjusted dose planning, a single disruption can cancel a patient’s treatment.
Getting this stage right requires more than courier coordination, it demands integrated logistics planning from the outset, including GPS-enabled tracking, temperature control, and delivery protocols aligned with clinical operations.
Key considerations at this stage include:
- Can I get the dose where it needs to go, exactly when it’s needed?
- Do my shipping processes account for radioactive decay and patient treatment schedules?
- Am I working with logistics partners that understand the nuances of radiopharmaceutical transport?
- How will I ensure dose potency and safety upon arrival at the treatment site?
End-to-end support purpose-built for radiopharmaceuticals
At Nucleus RadioPharma, we offer true end-to-end CDMO services built specifically for radiotherapeutic development. Our team and infrastructure are equipped to support early-stage formulation, clinical execution, commercial-scale manufacturing, and the complex logistics required to reach patients on time.
Whether you’re advancing a new candidate or expanding production for an approved therapy, we help you move faster, stay compliant, and maintain control at every stage.
Let’s talk about how our end-to-end model can support your radiotherapy program.