Cell and gene therapy logistics is the controlled movement of living cells from the collection centre to manufacturing and back to the patient as a finished dose, without the product ever warming above –150 °C. It relies on qualified dry shippers, continuous temperature logging, an unbroken chain of identity and handovers that follow Good Distribution Practice (GDP).
In cell and gene therapy, logistics is not a back-office function. An autologous CAR-T dose is made from the cells of exactly one patient. If it is lost in transit, there is no replacement on a shelf, only a second apheresis and several more weeks of manufacturing, assuming the patient's condition still allows it. This article walks through the vein-to-vein chain, shows where temperature excursions actually happen, and sets out what containers, data loggers and documentation need to deliver.
An autologous therapy passes through several stations. At each one, responsibility changes hands, and every handover is a potential break in the cold chain.
Apheresis at the collection centre: the patient's white blood cells are collected. Depending on the process, they ship fresh at 2–8 °C or are cryopreserved on site.
Shipping to manufacturing: cryopreserved starting material travels in the vapour phase of liquid nitrogen to the manufacturer, often across borders.
Manufacturing and release: cells are modified, expanded, filled into cryobags and frozen at a controlled rate. Until QP release, the dose sits in quarantine in a cryogenic tank.
Shipping to the treatment centre: the released dose travels in a dry shipper below –150 °C to the hospital.
Storage and thaw at the clinic: the hospital receives the dose into its own cryogenic storage and thaws it only immediately before infusion.
Allogeneic therapies made from donor cells skip the patient-specific return leg. Instead, larger batches are distributed to many sites, and on-site storage tends to last longer. For the storage side of CAR-T products, see our article on cryogenic storage for CAR-T cell therapies.
The glass transition of water lies at roughly –135 °C. Below it, cryopreserved cells undergo no meaningful ice recrystallisation or metabolic activity. The –150 °C limit adds a safety margin to that threshold. Above it, ice crystals can grow and damage cell membranes. The damage is invisible from outside and only shows up after thaw as reduced viability.
For cryogenic shipping, that means the average temperature is not what matters. Every short spike does. A few minutes of exposure during a transfer can be enough to put a dose in question, which is why manufacturers and regulators expect continuous recording across the whole route and a documented assessment of every excursion.
Excursions rarely happen on the road or in the aircraft hold, provided the container was prepared properly. The risky moments are the ones where people intervene:
To validate the full chain from freezing to storage to shipping, read our guide to cryogenic cold chain validation.
A dry shipper is a vacuum-insulated transport container whose inner chamber is lined with a porous absorbent. Before dispatch it is charged with liquid nitrogen, which the absorbent soaks up completely; any excess is poured off. The result is a vapour-phase environment well below –150 °C with no free liquid that could spill.
This design has two advantages. Samples stay in the vapour phase and never touch liquid nitrogen, which lowers the risk of cross-contamination. And because the nitrogen is fully absorbed, these shippers are not regulated as dangerous goods for refrigerated liquefied gases under the IATA Dangerous Goods Regulations (Special Provision A152), so they can fly as air cargo.
Every container type used for investigational or commercial product needs qualification, covering:
Hold time depends on model, payload and ambient conditions, and is matched to each route with a clear reserve over planned transit. Our dry shipper selection guide for cryogenic transport covers the selection criteria in detail.
Without a temperature record there is no proof that a dose stayed below –150 °C in transit. Modern data loggers sample the internal temperature at short intervals, store the readings in a tamper-evident way and allow a fast release decision on arrival. Some systems also report location and temperature in real time, so the team can still intervene when a shipment is delayed.
The logger itself must be calibrated, rated for temperatures below –150 °C, and its data unambiguously linked to the shipment and therefore to the dose.
Two terms define the cell therapy supply chain:
COI protects the patient from mix-ups; COC protects product quality. Both have to continue inside the hospital's cryogenic storage, because the chain does not end at the loading dock. It only changes container.
Shipping cell therapies sits under several frameworks at once:
In practice these requirements are translated into quality agreements between manufacturer, courier and hospital. On site, what matters is that receipt, interim storage and return of shippers are written into SOPs and that the equipment involved is qualified. For the trial setting, see our article on cell therapy clinical trial storage.
The cold chain does not stop at the hospital door. The dose moves into a cryogenic tank, often stays there for days or weeks, and is retrieved on treatment day. Containers, racks, cassettes and monitoring should therefore fit together: a bag that travels in a cassette inside the dry shipper should move into the storage tank without repacking. Every extra handling step is a risk.
Consarctic® is a market-leading German manufacturer of cryogenic systems for the life sciences, serving customers in more than 30 countries, and covers this chain as one integrated system: BIOFREEZE® controlled rate freezers for freezing, ABV+, ABS+, BSD+ and BSF+ tanks for storage, and the ASR+ series for transport. The ASR+ cryogenic transport containers are dry shippers with no free liquid nitrogen, which makes them IATA-compliant for air transport, and are available with integrated data loggers for continuous temperature documentation. Several sizes cover everything from small clinical shipments to larger transfers between sites.
Consarctic has been certified to ISO 13485 since 2003 and supports customers with IQ/OQ by certified technicians and a 24/7 emergency service. For temperature validation of dry shippers, read our article on cryogenic sample shipping with the ASR+ series.
After manufacturing, CAR-T cells are frozen at a controlled rate in cryobags and shipped in a dry shipper in the vapour phase of liquid nitrogen, below –150 °C, to the treatment centre. A data logger records the temperature, and a unique identifier keeps the dose linked to its patient. The apheresis starting material travels to the manufacturer either fresh at 2–8 °C or cryopreserved, depending on the process.
Chain of identity is the unbroken link between a patient, their starting material and the finished product across every step of a personalised therapy. A unique identifier follows each unit from collection to infusion, so that no patient can receive another patient's dose.
It depends on the model, payload, ambient temperature and orientation. Depending on size, hold times range from a few days to several weeks. For cell therapy shipments, hold time is qualified under realistic conditions and matched to planned transit with a clear reserve.
In the EU, the GDP Guidelines (2013/C 343/01) and the GMP guidelines for ATMPs apply, and air freight follows IATA regulations. ISO 21973 sets general requirements for transporting therapeutic cells, and collection and treatment centres additionally follow FACT-JACIE Standards. Compliance is documented through qualified containers, validated routes, continuous temperature records and quality agreements.
In cell and gene therapy logistics, success is decided less by the distance than by the care taken at every handover. Qualified dry shippers, complete temperature data and an unbroken chain of identity turn a risky journey into a controlled process.
Planning cell therapy shipping routes or qualifying your dry shippers? Talk to Consarctic's cryogenics specialists about the ASR+ series and the right cryogenic infrastructure for your site.