While radiotherapies hold great potential in the fight against cancer, organizations bringing these products to patients face significant challenges, especially related to manufacturing and distribution.
Unlike traditional pharmaceuticals, radiopharmaceutical therapies must contend with the same stringent quality standards coupled with accelerated timelines, lack of inventory, complex logistics, and capacity constraints.
Add to these challenges the fact that the radiopharmaceutical drug product manufacturing segment is still relatively new and underdeveloped. As the demand for radiopharmaceutical therapies grows, so too does the need for robust solutions to these multifaceted problems.
1. Quality standards
The stakes are incredibly high in therapeutic radiopharmaceutical manufacturing. Unlike diagnostic agents, where a mistake might result in a poor image and the need for a retest, errors in therapeutic radiopharmaceuticals can cause significant harm to patients.
Naturally, this has led to the need for meticulous and thorough planning at all stages, from early development through validation, to maintain stringent quality controls and meet regulatory requirements. A deep understanding of Quality by Design (QbD) with sterile drug product quality standards is essential.
QbD embeds quality into every step of the project—from equipment design to staff training—to ensure these products meet high standards before testing even begins. However, without the right expertise, innovators can struggle to implement QbD and meet regulatory standards, leading to significant compliance issues and potential risks to patient safety.
2. Accelerated timelines
The pace at which radiopharmaceutical therapies can advance is a huge positive that also further complicates the supply chain landscape. Traditional pharmaceuticals can take a decade from discovery to market approval, allowing ample time to plan and build manufacturing capacity.
In contrast, radiopharmaceutical therapies can be approved in roughly half that time, forcing companies to invest in capacity much earlier in the process. This accelerated timeline means companies must take on significant financial risk sooner than they might be prepared to, which can be a daunting prospect for many innovators. Key partnerships with Contract Development and Manufacturing Organizations (CDMOs) are a way to mitigate that risk and move forward without large capital costs.
3. Lack of inventory
Radiopharmaceutical therapies are unique because the key raw material and the final drug product have only a few days of shelf life due to the physics of radioactive decay. This results in a “just-in-time” supply chain, where timing and execution are absolutely critical. Unlike other industries where manufacturers can stockpile key items, radiopharmaceuticals have no inventory buffer and require precise coordination to ensure timely delivery from production to the point of use.
Maintaining multiple supply agreements for isotopes and developing robust processes to reliably deliver without waste is necessary to meet the needs of patients who cannot wait.
4. Complex logistics
Patient doses must be shipped across vast distances, both domestically and internationally, with no time to spare. Given their limited shelf life, any delay in the production, release, or distribution can render the product useless. For example, a thunderstorm could delay air travel, causing a critical shipment to be stuck in transit. Without robust tracking and redirection capabilities, these unexpected delays can lead to significant waste, increased costs, and potential harm to patients awaiting treatment.
The logistics involved in this process are mission-critical, and any disruption can lead to significant delays in patient care. These complexities are precisely why we’re advancing a regional distribution model with real-time tracking to reduce risk and increase reliability to bring our clients’ radiotherapies closer to patients.
5. Capacity constraints
As this breakthrough technology progresses, innovators run a real risk of being unable to reserve the capacity needed to deliver for large-scale clinical trials and commercial launches. This capacity crunch involves both the physical equipment and facilities to manufacture sterile radiopharmaceutical drug products, as well as the human resources and expertise needed to handle the specialized scientific, regulatory, and operational demands required to develop and produce these therapies.
Equipment and talent scarcity make it difficult for innovators to develop their capabilities in-house. Because of this, more organizations are turning to specialized CDMOs that have already built that capacity to bridge the gap.
Overcome challenges with CDMO expertise
End-to-end radiopharmaceutical CDMOs offer the expertise and infrastructure needed to navigate these unique challenges.
At Nucleus RadioPharma, our team of experienced professionals deeply understand the complexities of radiopharmaceutical therapy drug products and are equipped to manage the entire process, from initial formulation, process, and analytical development to clinical and commercial manufacturing and distribution.
Need help bringing your life-saving treatments to market? Get in touch.