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Leveraging Cell and Gene Therapy Insights for Successful Radiopharmaceutical Operations

Cell and Gene Therapy (CGT) and Radiopharmaceutical Therapy (RPT) are two classes of therapeutic treatments that have emerged from recent scientific advancements and are increasingly serving patients with innovative medicines in clinical and commercial settings.¹ Both approaches aim to improve patient outcomes through targeted interventions for complex, difficult-to-treat diseases. The RPT field is experiencing accelerated growth, driven by increasing clinical trials and multi-billion-dollar investments in precision oncology and other advanced therapies.² However, this rapid growth introduces challenges in scaling novel treatments, ensuring manufacturing consistency, managing complex supply chains and achieving regulatory approvals.

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In recent years, pioneering companies in the CGT space already developed best practices to address operational hurdles that come with the accelerated growth of a sensitive and highly regulated innovative therapy. Lessons learned from CGT provide valuable insights that RPT companies can adapt to enhance their own capabilities. This paper explores how proven CGT approaches to compliance, coordination, traceability, logistics and partnerships can strengthen RPT operations, enabling companies to scale efficiently while maintaining safety, quality and regulatory compliance.

Leveraging Cell Gene Therapy Insights Successful Radiopharmaceutical Operations Figure 1

Regulatory Compliance & Quality

RPT companies operate within a complex regulatory environment, balancing requirements from the Food and Drug Administration (FDA) for pharmaceuticals and the Nuclear Regulatory Commission (NRC) for radioactive materials. This dual oversight demands cohesive systems that address manufacturing, transportation, administration and disposal, while maintaining rigorous documentation and alignment with FDA and NRC guidelines.³

Maintaining high standards across the value chain requires consistent performance from clinical staff, logistics providers and manufacturing partners. In the CGT space, companies have successfully established compliance frameworks that standardize processes across clinical and commercial environments. Proven best practices include:

Comprehensive Training Programs: Structured training for clinical staff to ensure adherence to protocols and optimal administration of therapies
Onboarding Procedures: Formalized processes to align third parties with operational standards
Mock Audits and Audit Playbooks: Tools for conducting thorough assessments and identifying improvement areas through simulated audits and standardized protocols
Performance Management Protocols: Systems for monitoring performance metrics and driving continuous improvement across the value chain

For RPT companies, additional layers of compliance are necessitated by the involvement of radioactive materials. NRC regulations cover aspects such as licensing, inspection, enforcement, disposal and security to ensure the safe use of radioactive substances. Key considerations include:⁴

Licensing and Inspections: NRC issues licenses for radioactive materials and conducts inspections to verify compliance with safety protocols and emergency plans
Waste Disposal: NRC regulates the storage, transport and disposal of radioactive materials to prevent environmental contamination and harm to the public
Security Protocols: The NRC enforces stringent security measures to prevent unauthorized access or misuse of radioactive material

Implication for RPT: CGT’s approach to traceability, proactive regulatory engagement and standardized processes offers valuable insights for RPT companies. Applying these principles can enhance compliance systems, ensured quality is a priority at the earliest point, and maintain alignment with both FDA and NRC requirements.

Patient and Therapy Coordination

RPT requires precise coordination due to the extremely short shelf life of radioactive components, with half-lives often measured in hours or days.⁵ Unlike conventional pharmaceuticals, radiopharmaceuticals cannot be stockpiled. Each batch must be produced for a specific destination and shipped immediately upon completion.

The need for seamless coordination is similar to the intricate scheduling required for autologous cell therapies in CGT, where patient-specific cells must be collected, modified and returned for treatment within narrow windows of viability. While RPT does not involve the same sensitivity of patient-derived starting material, it follows a similar made-to-order model with strict timing requirements and no room for error.

Implication for RPT: Learnings from CGT demonstrate the value of integrated coordination systems that align manufacturing capacity, logistics availability and treatment center scheduling through real-time monitoring and comprehensive planning. Effective systems can dynamically adjust for disruptions such as patient cancellations, manufacturing delays or logistical issues, ensuring timely treatment delivery while minimizing waste and maximizing efficiency. Adapting these coordination practices can help radiopharmaceutical companies address challenges related to extremely short product shelf life, limited global manufacturing capacity and complex logistics, while improving reliability and patient outcomes.

Product Tracking and Traceability

Implementing a robust track-and-trace process is essential for RPT due to its high-risk nature and stringent regulatory requirements. Ensuring safety, compliance and product integrity requires continuous oversight throughout the supply chain.

In the CGT industry, when manufacturing an autologous product, maintaining a consistent Chain of Custody (“CoC”) is critical to guarantee that each therapy reaches the intended patient without error. This process involves creating patient-specific IDs that serve as serial numbers throughout the supply chain, capturing key handoffs and ensuring traceability from collection, to production, to administration. CGT companies have successfully deployed centralized tracking systems ensuring data integrity and compliance. Proven technologies include:

Barcoding and RFID Tags: Enable precise tracking at each handoff point to prevent loss or misidentification
Real-Time Monitoring Software: Provides continuous oversight, allowing rapid response to potential disruptions
Data Management Protocols: Protect Personal Health Information (PHI) through encryption and adherence to privacy regulations

RPT companies face similar challenges but must also consider safety and security concerns related to radioactive materials. Effective tracking systems should cover all stages, including production, transport, clinical administration and disposal.

Implication for RPT: Comprehensive visibility is essential to prevent errors, ensure timely delivery and mitigate security risks. Integrating these proven tracking practices from CGT can significantly improve RPT’s ability to meet stringent regulatory requirements, reduce risks and ensure safe and efficient delivery of treatments.

Specialized Logistics and Transport Management

RPT requires precise and reliable logistics management due to the short shelf life of radioactive materials and stringent handling requirements. Any delays in transport may render a treatment ineffective, forcing the manufacturing process to restart. Additionally, regulations concerning hazardous materials handling, radiation shielding and disposal further complicate logistics.²

In Cell and Gene Therapy , companies have addressed similar complexities by partnering with specialty couriers experienced in handling sensitive biologics. Shipping lanes are thoroughly validated and monitored and couriers provide additional end-to-end services such as:

GPS Tracking: Enabling real-time monitoring of shipments to ensure timely delivery
Temperature-Controlled Transport: Maintaining product integrity throughout transit
Expedited Customs Clearance: Minimizing delays by streamlining border-crossing processes
Shipment Simulations: Testing packaging integrity, timing, and route efficiency to identify potential failure points and address them proactively

Implication for RPT: RPT companies can leverage these best practices by adopting predictive route planning, proactive monitoring systems and shipment lane validation to enhance resilience and prevent logistical failures. Incorporating CGT’s approaches to logistics management can help RPT companies ensure timely, compliant, and consistent delivery of their products.

Strategic Partnerships

No single organization can manage all aspects of delivering CGT or RPT treatments. Both industries rely on collaborative partnerships to address supply chain complexities, including manufacturing, logistics and clinical administration. In CGT, companies partner with contract manufacturers, healthcare providers and specialized couriers to enhance scalability, streamline scheduling and ensure reliable delivery. Robust quality agreements and governance structures help maintain standards across all stakeholders.

RPT companies face similar challenges, with the complexity of securing the relevant isotopes from specialized suppliers.⁶ Establishing partnerships with these entities is essential for ensuring consistent supply, maintaining safety standards and reaching patients effectively. RPT companies can also benefit from developing training programs and standard operating procedures (“SOPs”) in collaboration with partners to align processes, reduce errors and enhance operational consistency.

Implication for RPT: By building partnerships focused on aligned standards, communication and governance, RPT companies can enhance operational resilience, scalability and patient access. Applying CGT’s collaborative models to the RPT ecosystem offers a pathway for improving reliability and ensuring successful treatment delivery.

Conclusions

Radiopharmaceutical therapy stands to gain significantly from the operational lessons developed within the Cell and Gene Therapy industry. By prioritizing regulatory rigor, precise coordination, thorough tracking, agile logistics and collaborative partnerships, RPT companies can enhance their ability to deliver treatments safely, efficiently, and at scale. The five focus areas discussed are interconnected components of a successful RPT commercial operational model.

As the industry grows, hiring cross-functional experts with experience in CGT can help RPT companies develop creative solutions and adopt best practices proven effective outside of the radiopharmaceutical sub-domain. Continuously re-evaluating these focus areas and adapting proven strategies from CGT will be critical to sustaining operational resilience, achieving commercial success, and ensuring consistent patient access to life-saving treatments.

Footnotes:

1: Sandeep Singh Negi, “Radiopharmaceuticals Market to Double by 2029 – Here’s Why”, BCC Research (May 10, 2025)

2: Jack Bauers, PE, “Radiopharmaceuticals: A guide for manufacturers”, CRB Group

3: James Bertram, “FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices”, U.S. Food & Drug Administration (October 14, 2020)

4: Stuart Reed, “The Regulatory Landscape of Radiopharmaceuticals: Ensuring Safety and Effectiveness”, Regulink (February 16, 2024)

5: “SNMMI Concerned with IAEA Proposed Revisions to Specific Safety Requirements for the Transport of Radioactive Material”, Society of Nuclear Medicine & Molecular Imaging (November 13, 2024)

6: Frankie Fattorini, “Radiopharmaceutical deals drive sector growth despite supply crisis”, Pharmaceutical Technology (February 5, 2025)