Cell and Gene Therapy Logistics in 2026: 5 Supply Chain Challenges Pharma Leaders Must Solve

Cell and gene therapies require a supply chain built around the treatment, not just the shipment. Many therapies involve patient-specific materials, specialized manufacturing processes, strict temperature requirements and coordinated delivery to treatment centers.

For autologous therapies, a patient's cells may travel from the collection site to a manufacturing facility and then return to the clinical site for administration. Every handoff must preserve product identity, traceability and the required handling conditions.

As these therapies expand beyond clinical trials, pharmaceutical companies must evaluate whether their logistics networks can support commercial operations without compromising product quality or patient treatment schedules.

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1. Temperature Control Must Protect Product Integrity

Conventional pharmaceutical distribution models may not be suitable for cell and gene therapies. Depending on the product and its stability requirements, shipments may require refrigerated, frozen, ultra-low-temperature or cryogenic conditions.

Some cryopreserved cell therapies require transport below −150°C. Liquid nitrogen vapor shippers, qualified packaging and temperature monitoring can help maintain the required conditions throughout transit. <Cite refs={["turn980702search0","turn980702search3"]}/>

What pharma leaders should prioritize:

• Validate packaging and shipping systems for the product's required temperature range.

• Monitor temperature deviations and establish clear escalation procedures.

• Assess shipper preparation, conditioning and return logistics.

• Maintain contingency plans for flight delays, route disruptions and equipment failures.

Business opportunity: Logistics providers with qualified cryogenic infrastructure, monitoring capabilities and validated handling processes can support manufacturers that lack the resources to build every capability internally.

2. Chain of Identity Must Remain Unbroken

In autologous cell therapy, the starting material and final product are linked to an individual patient. A mix-up can compromise treatment and create serious patient-safety risks.

Two related controls are essential:

• Chain of identity (COI): Confirms that the biological material and resulting therapy remain associated with the correct patient.

• Chain of custody (COC): Records who handled the material, where it moved and when each transfer occurred.

These controls must operate across collection centers, manufacturers, logistics providers, storage facilities and hospitals. Documentation and verification at each handoff are fundamental to preventing identification errors.

What pharma leaders should prioritize:

• Use consistent identification and documentation protocols across partners.

• Reconcile shipment records with manufacturing and patient-treatment records.

• Establish clear responsibility for each custody transfer.

• Test traceability procedures before scaling a therapy's distribution network.

Business opportunity: Digital orchestration platforms and traceability solutions can help companies connect logistics events with patient-specific manufacturing workflows and reduce fragmented recordkeeping.

3. Time-Sensitive Delivery Requires End-to-End Coordination

For some therapies, logistics delays can affect manufacturing schedules, product usability or the planned treatment date. The challenge extends beyond the courier: cell collection, manufacturing capacity, quality release, delivery and clinical-site readiness must work together.

A shipment may arrive on time yet still miss its intended treatment window if the receiving site is not ready or the manufacturing schedule changes.

Industry guidance published in September 2026 identifies coordination among collection, manufacturing, release testing, preconditioning and infusion scheduling as a central operational requirement for autologous therapies.

What pharma leaders should prioritize:

• Synchronize collection appointments with manufacturing slots.

• Coordinate quality release and dispatch milestones with clinical schedules.

• Track shipments in real time and define escalation triggers.

• Prepare alternative routes and contingency plans for transport disruptions.

• Confirm receiving-site readiness before dispatch.

Business opportunity: Companies offering shipment visibility, control towers, route planning and integrated scheduling can help manufacturers manage complex delivery networks more proactively.

4. Specialized Logistics Partners Must Be Evaluated Beyond Price

Not every pharmaceutical logistics provider has the infrastructure, training and operating procedures needed for advanced therapies. Partner selection should reflect the therapy's temperature profile, handling requirements, geographic footprint and traceability needs.

Several established providers operate in this space, including:

• Cryoport Systems: Specialized temperature-controlled logistics and supply chain services for life sciences.

• Marken: Advanced therapy logistics, cryogenic transport, shipment oversight and regulatory support.

• World Courier: Specialty pharmaceutical transportation and global distribution services.

• DHL: Healthcare logistics capabilities that can support temperature-sensitive and time-critical shipments.

Provider capabilities vary by service, geography and shipment requirements, so manufacturers should verify the specific qualifications and infrastructure relevant to each program.

A structured partner assessment should examine:

Business opportunity: Qualified regional logistics providers, packaging suppliers and digital platform companies can explore partnerships with established networks to address specialized or underserved routes.

5. Cross-Border Compliance Can Delay Critical Shipments

International shipments may involve customs clearance, import permits, biological-material documentation, dangerous-goods requirements and country-specific rules. The applicable requirements depend on the material being transported, its classification, the countries involved and the purpose of the shipment.

A compliant shipment therefore requires more than selecting a fast courier. Documentation, regulatory responsibilities and clearance procedures must be established before dispatch.

What pharma leaders should prioritize:

• Map import and export requirements for every planned route.

• Confirm permits, declarations and supporting documents before shipment.

• Clarify responsibilities among manufacturers, couriers, customs brokers and receiving sites.

• Develop alternative routing plans for clearance or transport disruptions.

• Review requirements whenever a new country, product type or logistics partner is introduced.

Business opportunity: Regional regulatory expertise and route-specific logistics intelligence can help companies assess new geographies without relying on a single global distribution model.

Where Are the Next Business Opportunities?

The next challenge for cell and gene therapy companies is to connect logistics decisions with manufacturing capacity, treatment-center readiness and commercial expansion.

These insights can help pharmaceutical leaders identify operational gaps, evaluate external partners and prioritize investment in the parts of the supply chain most likely to constrain expansion.

How Towards Healthcare Supports Cell and Gene Therapy Leaders

Towards Healthcare supports life sciences decision-makers with competitive intelligence and strategic insights across the cell and gene therapy ecosystem.

Its capabilities can help companies assess:

• Company and competitor intelligence: Compare logistics providers, technology platforms and service capabilities.

• Supply chain mapping: Assess infrastructure, geographic coverage and potential partnership opportunities.

• Customized dashboards: Organize company, pipeline, facility and ecosystem intelligence.

• Buyer identification: Identify relevant manufacturers, CDMOs, clinical networks and potential partners.

• Strategic opportunity assessment: Evaluate gaps in logistics services, regional coverage and commercial readiness.

The strategic question is not simply whether a therapy can be shipped. It is whether the supply chain can deliver the right product, to the right patient, at the right time, with the required quality and traceability controls.

Assess your cell and gene therapy supply chain opportunities with Towards Healthcare.

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