Unlike more traditional pharmaceuticals with well-established manufacturing supply chains, radiotherapies have unique challenges and complexities to consider before choosing a contract development and manufacturing organization (CDMO) partner.
The short shelf-life of modern radiotherapies, coupled with the fact that they are sterile injectable drug products, require a different approach to raw materials acquisition, production, packaging, testing, and shipping to minimize costs and prevent failures.
Taking a radiotherapy drug product from research to manufacturing demands meticulous planning and a strategic approach. Small biotech organizations often do not have the time or resources to create their own manufacturing footprint and depend on successful partnerships with CDMOs.
Big pharmaceutical companies may have some internal capacity, but they still need to partner with CDMOs to support a growing portfolio and effectively manage risk.
Both biotech and pharmaceutical organizations must be prepared to address a myriad of challenges. Before entering a radiotherapy manufacturing partnership, they should consider four critical questions.
1. Does your CDMO partner have the expertise for a smooth technical transfer?
The ability to swiftly install, qualify, and validate the production process and testing methods is key to success when outsourcing a valuable product like radiotherapies. Innovators are in a race with a limited timeframe to get the product to patients, so every minute, hour, and day is critical.
An experienced CDMO will already have the supplier relationships, production and analytical equipment, and standard operating procedures in place to allow for a fast transfer of the product. Method validation, engineering runs, and full process validation must occur quickly without costly errors and repeats. A team that has seen it before is more likely to avoid missteps.
2. Will your CDMO partner meet the quality and regulatory requirements?
Both biotech and pharma companies must build a compliance framework to effectively manage the stringent and rapid regulatory environment that comes with manufacturing radiotherapies. The right CDMO partner will meet those requirements and reduce risk.
Timely FDA approvals for raw materials are critical to avoid production delays. Radiotherapies are still relatively new to regulators, who may not comprehend the time-sensitive nature of these products. Clear, concise communication and deep radiotherapy expertise are essential for ensuring cooperation and maintaining your production and delivery schedule.
Shipping radioactive materials requires compliance with several regulations, from testing the containers to chain of custody. Partnering with a CDMO that can handle the entire supply chain and understands the intricacies of transporting radioactive materials can mitigate risks associated with delays and regulatory compliance.
3. How will your CDMO partner expand capacity as the demand for your drug product increases?
Robust capacity planning mechanisms ensure companies are well-prepared to meet the rapid and dynamic needs of the radiotherapy market. Your organization will need to accurately forecast demand and maintain flexible production capacity to meet peak demands and avoid wasted doses.
You must consider factors like clinical trial enrollment rates, dosing strategies, and seasonal demand fluctuations. For instance, a company might need to double its production output in the weeks before and after holidays to meet actual patient demand.
It’s imperative to build flexibility into your production process to handle not only unexpected spikes in demand but also supply chain disruptions. Working with a CDMO that has relationships with multiple isotope suppliers and the ability to aggregate demand is one way to reduce risk. Another would be investing in excess capacity or scalable production facilities that can be ramped up or down based on demand.
4. Can your CDMO partner manage the complete project without significant oversight?
Establishing open communication and collaborative relationships with external partners is crucial to managing these complex and urgent projects. Given the specialized nature of radiotherapies, companies often rely on external experts for all aspects of production, from raw material supply to quality control.
Your CDMO project management team must establish clear lines of communication, enforce a solid governance structure, and plan for rapid issue escalation. Time and truth are critical for each dose and the project as a whole.
Your end-to-end radiopharmaceutical CDMO partner
Who you partner with can be a game-changer in this niche, competitive industry.
At Nucleus RadioPharma, we offer end-to-end radiopharmaceutical CDMO services to help biotech and pharmaceutical companies bring their therapies to market quickly and safely.
Our expertise spans the entire radiotherapy journey—from development and regulatory all the way to production and delivery. Plus, our relationships with hospitals, universities, radioisotope suppliers, and regulatory agencies allow us to help our clients with any challenges they encounter.
Are you looking for an end-to-end partner to help you through the complexities of bringing radiopharmaceuticals to market? We can help.