Delivering cell and gene therapies safely: 10 Strategies for end‑to‑end logistics control

Start with a network you can prove, not assume 

A route that looks viable on paper can break down due to limited flight availability, variability across customs authorities, or local handling constraints. These are not edge cases. They are predictable failure points. 

Establishing control begins with lane qualification. That means mapping each origin-to-destination pathway in detail and validating that it can consistently meet timing, temperature, and handling requirements before the first shipment moves. 

“Flight availability can make or break a route,” says Frend. “If there’s only one flight every few days, that’s a built-in risk — so we help clients plan smarter from the start.” 

 

Maintain temperature control across transitions, not just endpoints 

Temperature excursions rarely occur during steady-state transport. They happen during transitions. Hand-offs between facilities, loading events, or unexpected delays. 

Maintaining stability requires more than selecting the right packaging. It requires validated systems across all temperature ranges, combined with continuous monitoring that identifies trends before thresholds are breached. 

Cencora uses validated packaging from refrigerated (+2 °C to +8 °C) through cryogenic conditions (≤ –150 °C in liquid nitrogen vapor phase), supported by monitoring at 15-minute intervals. 

“Our technology shows when a shipment’s temperature is trending high or low,” explains Schier. “That early visibility lets us protect the therapy before there’s any chance of impact.” 

Treat chain of identity and custody as non-negotiable controls 

In autologous therapies, a patient’s cells become part of the supply chain – which makes a break in traceability completely unacceptable. “The stakes for the patients are high in these situations,” notes Louis Cicchini, PhD, Senior Director of Scientific Affairs and Strategic Partnerships for CGT at Cencora. He adds:  

An autologous therapy asks a vulnerable patient to entrust not only their health, but their own cells, to a distant manufacturing journey. In a climate of understandable skepticism toward genetics and biologics, particularly in underserved or vulnerable communities, the logistics provider must serve as an exceptional steward of trust and safety, making integrity, transparency, and chain-of-custody nonnegotiable. 

Absolute traceability is a foundational control rather than just a compliance requirement. Every hand-off must be recorded, verified, and auditable in real time. 

Cencora enables this by maintaining a therapy’s chain of identity and chain of custody by creating an auditable, verified log of each hand-off.  

“When every shipment links back to a single patient, there can be no uncertainty,” says Schier. “That’s why we build our processes around absolute traceability.”

 

Turn visibility into decision-making, not just tracking 

Visibility alone does not reduce risk. It only becomes valuable when it drives action. In CGT logistics, stakeholders need more than location updates. They need the ability to anticipate arrivals, respond to delays, and coordinate resources in real time. 

At Cencora, we provide customers with actionable 24/7 shipment visibility. Using a combination of GPS, mobile (cellular) data, and temperature-tracking devices, our customers can easily access live data and downloadable reports and respond as needed.  

“Providers can see when the shipment is five kilometers out and prepare their team,” says Frend. “That visibility builds confidence at every stage.” 

Build response capability, not just contingency plans 

Contingency plans often exist as documentation. They are far less effective if they have not been tested under real conditions. 

CGT therapies aren’t immune to the realities of shipping. Bad weather, customs issues, and even flight cancellations can make the difference between the therapy being delivered on time and consequences that can’t be undone. 

Cencora plans contingencies for each scenario, from alternate airports to standby drivers. “We pride ourselves on rapid, coordinated intervention,” says Schier. “If challenges arise, our teams act immediately to keep the therapy safe. Because at the end of the chain is a patient waiting.” 

Control the network, don’t outsource risk mitigation 

CGT therapies are much more than just freight. They are often irreplaceable, time-sensitive treatments where failure isn’t an option. That’s why Cencora ensures that all of our third-party local service provider (LSP) partners are performance-vetted and trained to the same standards as our in-house team.  

Unlike global integrators, such as express parcel carriers, Cencora doesn’t treat a life-saving therapy like a standard package. “We’re not moving every day parcels,” Schier says. “Every partner we use understands that this shipment can be the difference between life and death.” 

Combine technology with human intervention 

Technology plays a critical role in detecting issues, but it does not resolve them. Alerts related to temperature, location, or delays must trigger a coordinated human response. That includes notifying stakeholders, deploying local resources, and managing the situation in real time. 

At Cencora, technology enables early detection, while operational teams drive resolution.  “Technology detects. People resolve,” explains Schier. 

Design workflows around the therapy 

Different therapies have different paths. CGT supply chains are not standardized. Each therapy introduces unique requirements related to timing, handling, and site capabilities. 

However, manufacturers may try to replicate the same processes used in a clinical trial for health systems after the therapy has been commercialized. In some cases, hospitals may lack the critical infrastructure. “Some hospitals can’t store dry shippers,” says Frend. 

Operational control depends on adapting workflows to those constraints. That may include after-hours pickups, just-in-time delivery models, or customized documentation processes.  

Frend describes how Cencora’s CGT project managers and solutions facilitate this adaptation. “We build flexible solutions, so the therapy arrives exactly when and where it’s needed.” 

Use performance data to prove control 

Regulators won’t just take your word for it. You must be able to provide evidence.  

Cencora continuously monitors on-time performance and deviation rates across its network. We share that information with manufacturers, allowing you to validate your own compliance metrics and demonstrate reliability to regulators. 

Integrate sustainability without introducing more risk 

Sponsors aren’t just interested in reliability.  They’re also interested in adopting more eco-friendly shipping practices.  

Cencora is committed to sustainability. We continually evaluate new materials that can help us reduce waste and emissions, and deploy reusable packaging systems across all temperature ranges.  

“Clients increasingly ask about sustainability,” Schier says. “Reusability isn’t just good practice — it’s becoming an expectation.” 

From logistics execution to operational control 

In cell and gene therapy, the supply chain isn’t moving product, it is an extension of clinical care. Achieving precision in transport is supporting precision in the treatment. The supply chain is the therapy’s heartbeat — invisible when it works, catastrophic when it doesn’t. 

Organizations that treat CGT logistics as a controlled, integrated system—rather than a transactional vendor service—are far better positioned to scale, adapt, and deliver consistent, patient‑critical outcomes.