The advent of cell and gene therapies (CGTs) has ushered in a new era of medical treatments, offering hope for patients with previously untreatable conditions. However, the supply chains for these advanced therapies are inherently complex; they require meticulous coordination and management to ensure the safety, efficacy, and timely delivery of treatments.  

Here, we’ll explore the intricacies of CGT supply chains and the critical challenges developers must overcome to quickly and safely deliver life-saving CGTs to patients worldwide. You’ll discover the key elements of a successful supply chain management strategy, the indispensable value of an experienced external partner, and how Catalent’s Case Management Services can help position your program for long-term success.  

Understanding cell and gene therapy supply chains 

CGT supply chains are unlike any other in the pharmaceutical industry. They involve a series of highly specialized steps: from collecting cells or genetic material, to manufacturing the therapy, to coordinating the final delivery to patients.  

Each step is critical and time-sensitive, with the viability of the therapy often hanging in the balance. This complexity is further heightened by the need for strict regulatory compliance, temperature control during transportation, and maintenance of the chain of custody and chain of identity. 

Doing this successfully relies on a number of stakeholders, including patients, healthcare providers, manufacturers, regulatory authorities, logistics providers, and more. Each stakeholder has specific needs and responsibilities; developers need a plan to facilitate communication and collaboration with all of them.  

Developers also need a strategy to share critical information so therapies remain viable and arrive on time—including product specifications, manufacturing details, regulatory compliance documents, and logistics information.  

Given the complexity of CGT supply chains, it’s no surprise that delivering CGT therapies quickly and safely is loaded with challenges. 

These can include: 

1. Complex logistics: Precise timing and temperature control during transportation, as well as GPS-enabled real-time tracking for visibility  

2. Regulatory compliance: Adhering to stringent regulatory standards across different jurisdictions 

3. Data management: Ensuring the integrity and security of critical data across the supply chain—including product authenticity and traceability—is essential to maintaining trusted chain of identity and chain of custody 

4. Stakeholder coordination: Keeping all stakeholders informed and aligned on the status of the therapy

5. Scalability: Scaling manufacturing to meet market demand, or scaling delivery to all relevant markets.  

Considerations for managing CGT supply chains effectively  

Given these challenges, developers must take a multifaceted approach to managing their supply chains.  

The ideal strategy should involve: 

1. Advanced planning and coordination: Establishing clear communication channels and timelines across stakeholders is crucial for timely delivery and minimal disruptions. 

2. Robust cold chain logistics: Cell and gene therapies often require strict temperature control during transportation and storage. Investing in advanced cold chain logistics solutions—such as temperature-controlled packaging, real-time temperature monitoring, and GPS-enabled tracking—is essential to maintain product integrity. 

3. Risk management and contingency planning: To mitigate potential disruptions, developers must implement robust risk management strategies and well-defined contingency plans. These tools enable teams to proactively identify supply chain bottlenecks and prepare alternative pathways. With the right plans in place, the supply chain remains resilient—ensuring therapies reach patients without delay. 

4. Advanced technology and systems: Investing in technology and systems for traceability, real-time monitoring, stakeholder communication through integrations, and predictive analytics can improve transparency, reduce risks, and optimize operations.  

5. Standardized processes: Developers should streamline workflows, allowing all stakeholders to work efficiently and reduce the possibility of delays.  

6. Collaboration and partnerships: Building strong partnerships with key stakeholders—such as suppliers, logistics providers, and healthcare institutions—can enhance supply chain resilience. Collaborative efforts can lead to shared resources, knowledge, and best practices that boost supply chain efficiency. 

Catalent’s Case Management Services is a game-changer for CGT supply chains 

Ultimately, the time, expertise, and technology required to manage CGT supply chains effectively are out of reach for many developers. Success often hinges on having a trusted external partner to help manage supply chain logistics.  

Catalent’s Case Management Services helps CGT developers optimize their supply chains and ensure the safe and timely delivery of advanced therapies to patients. 

Holistic support across CGT supply chains 

Catalent’s Case Management Services offers around-the-clock supply chain coordination and support, from the initial collection of cells to manufacturing and final delivery.  

The service is tailored to meet the specific needs of each project and can include: 

• Program onboarding: Designing the optimum shipment strategy, including backup routes, and conducting mock shipments to pressure test primary lanes 

• Dedicated case managers: Offering personalized, extensive supply chain management expertise and continuous status monitoring to ensure smooth orchestration 

• Scheduling support: Arranging starting material collection start date, manufacturing slots, and shipment pickup and delivery 

• Chain of custody and identity: Maintaining the authenticity and traceability of the therapy by ensuring that the right treatment reaches the right patient 

• Regulatory compliance: Ensuring that all aspects of the supply chain adhere to regulatory standards. 

By taking on the responsibilities of supply chain management, Catalent reduces the burden on internal resources and enhances scalability for future growth—allowing companies to focus on scientific innovation and research. 

Catalent’s Case Management Services in action: a case study 

One developer came to Catalent with significant barriers across its supply chain, including mismanagement of Harmonized Tariff Schedule (HTS) codes, delays in customs clearance, and prolonged transportation times.  

Catalent’s Case Management Services team acted swiftly, refining shipment strategies and establishing direct communication with global courier services. With this approach, we were able to: 

• Reduce delivery times in the USA-Australia corridor from 10 days to 52 hours (a 79% reduction) 

• Shorten delivery times in the USA-Europe corridor from 5 days to 43 hours (a 64% improvement). 

Ultimately, these improvements allowed patients to access therapy on time, without sacrificing oversight or control at any point in the process.  

The bottom line 

CGT supply chains are highly complex, requiring specialized expertise to manage effectively. For most developers, building this capability in-house is not only impractical—it can lead to costly delays and significant investments in technology and talent that may not deliver the expected outcomes. 

That’s where Catalent’s Case Management Services makes a difference. With deep expertise, end-to-end supply chain oversight, strong relationships with premium courier partners, advanced technology, and a patient-centric mindset, Catalent delivers customized strategies that address the unique challenges of CGT programs. 

This level of support helps ensure that advanced therapies reach the patients who need them—safely, efficiently, and on time. Because when the path is complex and the mission is critical, your supply chain partner should be as advanced as the therapy itself. 

To learn more about how we can help streamline your CGT supply chain, visit us online.  

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.