When CGT supply chains break down: 5 operational gaps that put patient outcomes at risk
Treatment delivery in cell and gene therapy (CGT) requires manufacturers to navigate intricate pathways, depending on extensive regulatory expertise, strategic consulting, robust distribution networks, and innovative logistics solutions.
For logistics in particular, each shipment represents a single patient and a defined treatment window, for which there is no margin for error. When supply chain operations fall short, the impact is immediate and irreversible.
Most organizations don’t recognize these risks until something goes wrong. The gaps tend to show up in subtle ways first, then escalate quickly. Optimal CGT supply chains tightly integrate logistics with clinical and manufacturing operations to address these gaps before it’s too late.
Here are five of these gaps. If you recognize any of these in the supply chain for your CGT, you should bring in a logistics partner with experience in advanced therapies.
1. Operational focus shifts away from patients to shipments
When logistics aren't properly orchestrated, internal clinical or manufacturing teams are often forced to step in as makeshift coordinators. This creates an "invisible" operational burden, with staff spending time tracking shipments and resolving courier delays—rather than focusing on treatments.
High-performing teams avoid this drain on resources by:
- Leveraging live location and condition data to maintain constant visibility.
- Using predictive alerts to identify potential issues.
- Sharing real-time insights across all stakeholders.
Catching a temperature swing or a delay early means you’re actively managing the outcome, not just documenting a failure after the fact.
Cencora’s CGT project managers coordinate every hand-off, aligning sites, couriers, and customs so your teams can focus on science and care — not logistics.
“Our role is to take that pressure away,” says Kelly Frend, Senior Manager, Personalized Supply Chain. “Sponsors should focus on patients, not paperwork.”
2. Operational signals don’t support early intervention
A shipment’s location doesn’t provide enough information to manage risk. Teams need continuous data about the shipment’s condition and projected trajectory for effective decision-making. And, without that, the window for intervention narrows. By the time a temperature deviation or delay is identified, response options are limited.
Effective teams maintain control by:
- Staying in the loop by watching live location and temperature data, rather than just checking a log after the fact.
- Setting up early-warning alerts to know if a shipment is drifting before it actually hits a critical limit
- Making sure everyone sees the same thing, from the lab to the courier
Catching a temperature swing or a delay early means you aren't just watching a disaster happen. It gives your team the opportunity needed to pivot, whether that's changing the route or stepping in to fix a handling error.
Cencora allows its sponsors to view this data directly through a customer portal, with location and temperature readings updated every 15 minutes to provide full transparency and rapid escalation if needed.
“We can see if a shipment is trending high or low in temperature before there’s any risk,” explains Eric Schier, Senior Manager, Personalized Supply Chain. “That gives us time to intervene fast and keep it stable.”
3. Contingency planning is unvalidated
Sometimes, teams document contingency plans but do not validate them under real conditions. When something goes wrong during an actual shipment, gaps begin to show. A reroute may take longer than planned. A backup courier may not be immediately available. Steps that looked straightforward on paper can stall once multiple teams must coordinate for the first time.
CGT logistics validation requires:
- Pre-defined and tested contingency pathways
- Local recovery options aligned to each lane
- Operational readiness before the first shipment moves
Unless there’s validation, it’s difficult to contain small disruptions. For example, a missed connection or handling issue can quickly push a shipment outside acceptable conditions.
Cencora CGT project managers develop documented response plans for every lane, rehearsed, and approved before the first live shipment.
“Every shipment has a contingency mapped out before it moves,” says Schier. “That’s what turns challenges into recoveries.”
4. Audit and compliance requests create operational strain
CGT programs come with strict documentation requirements, and teams often need records quickly. When audit trails or temperature data must be pulled together manually, things slow down, and risk goes up.
During audits, teams try to piece together what happened across different systems and emails. It’s not always clean. Records may be incomplete, or it may take longer than expected to track everything down. That’s where problems tend to surface.
When documentation is captured automatically, most of that work goes away. The records are already there.
Cencora captures complete audit trails automatically — from hand-off logs to performance metrics — giving sponsors the documentation they need for compliance and biologic license application (BLA) filings without the stress.
5. Execution breaks down without embedded operational alignment
CGT programs don’t work with transactional logistics relationships alone. Logistics providers need to be part of day-to-day operations, so they can immediately develop solutions alongside your team.
An effective logistics partner operates as an extension of your team, with:
- Direct alignment to your processes and priorities
- Familiarity with your sites and workflows
- Ongoing communication that supports rapid execution
This collaborative partnership enables teams to coordinate more quickly by sharing context and operating from a shared information base. That alignment allows teams to respond to changes without rework or miscommunication.
Cencora’s CGT project managers act as embedded teammates — accessible, informed, and proactive. “We stay closely connected with the sponsor’s team,” says Frend. “We visit their sites too, so when something changes, they don’t have to explain the context — we already know it.”
Furthermore, Cencora has an integrated suite of solutions designed specifically to help CGTs. CGT commercialization demands an approach purpose built for specific handling requirements, provider workflows, patient pathways, and reimbursement landscapes. Cencora’s CGT solutions help manufacturers advance from strategy to execution with fewer handoffs and greater continuity.
What is different for logistics designed for CGT
Addressing these gaps changes how teams manage, monitor, and recover shipments. Defined processes and real-time oversight guide how shipments are handled as conditions change. When those are in place, teams can respond in the moment rather than rely on infrastructure, networks, or ownership that may not hold up under pressure.
Supply chain design determines how consistently CGT shipments meet required conditions and delivery windows. Achieving that consistency requires validated courier networks, tested contingency pathways, and continuous monitoring.
Want to learn more? In an upcoming webinar, Eric Schier, Senior Manager, Personalized Supply Chain, will outline:
- Where risk typically emerges across CGT logistics
- How to identify and mitigate common failure points
- What operational strategies support consistent delivery
Register to learn the logistics strategies behind successful CGT programs. We’re going to discuss how these teams stay on top of their shipments and keep patient outcomes at the center of everything they do.
