Cold Chain Challenges for Cell and Gene Therapy Trials: What CROs Need to Know

Cell and gene therapies (CGTs) are redefining modern medicine. These highly personalised, precision-targeted treatments offer hope to patients living with rare, previously untreatable diseases. But while CGTs represent extraordinary scientific advancement, they also introduce a new frontier of logistical challenges, especially for Contract Research Organisations (CROs) responsible for study execution.

Unlike traditional pharmaceuticals, CGTs are living, highly sensitive materials. Many must be preserved at temperatures as low as –150°C to –196°C, move rapidly between manufacturing sites and clinical locations, and maintain absolute identity control. A single excursion, transit delay, or mislabelling error can render the therapy unusable — or worse, compromise patient safety.

This article explores the critical cold chain challenges facing CROs conducting cell and gene therapy trials and outlines best practices to safeguard material integrity, improve traceability, and maintain regulatory compliance throughout the supply chain.

The Unique Nature of Cell & Gene Therapy Logistics

CGTs differ from conventional clinical trial materials in several ways that directly impact logistics:

• They are often patient-specific (autologous) Meaning the therapy created for one patient cannot be used for another.

• They have exceptionally narrow viability windows Some must be administered within hours of manufacturing.

• They require ultra-low or cryogenic storage Often between –80°C, –150°C, or –196°C using dry shippers.

• They cannot be replaced easily if lost or damaged Manufacturing often involves harvesting the patient’s own cells.

• They require airtight identity management To prevent mix-ups that would compromise both science and safety.

These factors make CGT logistics a high-stakes, precision-driven discipline.

Ultra-Cold Transport: Protecting Living Materials

Cryogenic and ultra-cold transport is central to CGT trial success. Materials such as CAR-T cells, viral vectors, engineered tissue, and gene-modified cells require extremely low temperatures to maintain stability.

Key Challenges

✔ Preventing temperature excursions at extreme ranges

Traditional cold chain systems are insufficient. CGTs require high-grade dry shippers or cryogenic dewars capable of maintaining temperatures for long durations.

✔ Ensuring shipper performance consistency

Not all containers hold temperature equally; each unit must be validated.

✔ Managing dry shipper recharging and refilling

Shippers must be properly conditioned and refilled with liquid nitrogen before each transport cycle.

✔ Environmental variables

Ambient temperature, delays on tarmac, or poor handling can compromise stability.

Best Practices

• Use validated cryogenic shippers with documented hold times

• Implement real-time temperature and shock monitoring

• Conduct lane validation across all routes

• Work only with carriers familiar with CGT requirements

• Store detailed performance data for audit readiness

Arca BioLogistics specialises in these high-risk environments, ensuring that every shipment is handled with exact precision and full transparency.

Identity Management: Every Shipment Must Match the Right Patient

Few areas of logistics carry stakes as high as identity control in cell and gene therapy shipments. In autologous therapies, the material belongs exclusively to the individual patient it was sourced from. Any misidentification can have severe clinical consequences.

Key Challenges

• Managing chain-of-identity (COI) from collection through delivery

• Preventing mislabelling or administrative errors

• Maintaining COI during customs inspection or multi-leg handovers

• Ensuring site staff follow correct patient identification procedures

Best Practices

• Use tamper-evident labelling and digital identifiers

• Integrate COI into all digital tracking workflows

• Enable two-way verification between manufacturing sites and clinics

• Ensure logistics partners use closed-loop tracking systems

• Maintain detailed COI audit trails accessible via Arca Live™

With Arca Live™, CROs can monitor COI and COA (Chain of Custody) in a single platform, ensuring robust traceability throughout the lifecycle of each patient-specific therapy.

Traceability: Transparency Across the Entire Supply Chain

CGTs demand zero ambiguity. Every movement, temperature reading, and chain-of-custody handoff must be logged with absolute accuracy.

Why Traceability Matters

• Regulators expect full visibility from sample collection to administration

• CGT shipments involve multiple handovers

• Cryogenic containers must maintain integrity across continents

• Live, auditable data reduces regulatory and operational risk

Challenges

• Traditional tracking systems are insufficient for cryogenic logistics

• Gaps in visibility lead to delays or excursions

• Manual documentation introduces human error

• Multi-vendor workflows cause fragmented data reporting

Best Practices

• Deploy real-time GPS and temperature monitoring

• Use blockchain-inspired audit trails for tamper-proof COI/COA

• Centralise all tracking into a single visibility platform

• Train site staff and couriers on handling requirements

• Automate reporting for inspections and audits

Arca’s end-to-end digital monitoring ensures CROs always have access to real-time and historical shipment data, enabling fully informed decisions without guesswork.

Time Sensitivity: When Every Minute Counts

Cell and gene therapies often have extremely short viability windows. Some must be infused within a strict timeframe following manufacturing — leaving no margin for logistical delays.

Common Risks

• Customs hold-ups

• Inclement weather or airport congestion

• Missing documentation

• Incorrect packing or thawing at site

• Unexpected route changes

Best Practices

• Use validated, pre-approved customs routes

• Pre-submit documentation to minimise clearance delays

• Build contingency plans for every shipment

• Provide sites with simplified, pre-validated receiving protocols

• Establish rapid-response support teams

Arca’s consistency in transit performance helps CROs maintain predictability across even the most time-critical shipments.

Sustainability in CGT Cold Chain Logistics

Although CGT logistics require highly specialised materials, sustainability should not be sidelined. Many organisations are now expected to meet strict ESG targets.

Arca supports sustainability in CGT trials through:

✔ Reusable cryogenic packaging and loggers

Across all temperature ranges, reducing single-use waste.

✔ Carbon offsetting programmes

Allowing CROs to meet environmental commitments without compromising performance.

✔ Reduced product spoilage

Predictive planning and continuous monitoring lower waste from spoiled materials.

Sustainability and science are not competing priorities — they work hand in hand, especially when precision logistics minimises loss.

Efficiency Gains: Reducing Operational Burden for CROs

CROs often find that a disproportionate amount of operational time is spent on logistics administration: shipping forms, customs reviews, site communication, equipment validation, and monitoring.

Arca enables significant time savings by:

• Providing an 84% reduction in pre-shipment preparation time

• Offering a single platform (Arca Live™) for monitoring and record retrieval

• Using consistent, validated workflows

• Handling complex cryogenic coordination on behalf of CROs

With time freed from logistics management, CRO teams can focus on science, strategy, and patient outcomes.

Strategic Preparation Is Essential for CGT Supply Chain Success

Cell and gene therapy trials offer immense promise — but the logistical demands are unlike anything seen in traditional drug development.

CROs must navigate:

• Ultra-cold transport

• Identity and chain-of-custody management

• Real-time visibility

• Highly compressed timelines

• Global regulatory complexity

• Sustainability expectations

By partnering with a logistics expert like Arca BioLogistics, CROs can de-risk their CGT supply chains and ensure therapies reach patients safely, reliably, and sustainably.

If your organisation is preparing for CGT trials, now is the time to strengthen your cold chain strategy. Arca BioLogistics offers the precision, traceability, and real-time insight required to support the next generation of advanced therapies.