CAR T-cell therapy (Chimeric Antigen Receptor T-Cell Therapy) is considered one of the most significant breakthroughs in modern oncology. In this treatment, the patient's own T-cells are removed, genetically modified in the laboratory so that they recognize and destroy cancer cells, and then returned to the patient. The results for certain blood cancers such as acute lymphoblastic leukemia (ALL) or diffuse large B-cell lymphoma (DLBCL) are impressive: patients for whom there was no other treatment option achieve a complete remission in many cases.
However, there is a complex logistical chain between the removal of the T cells from the patient and their re-infusion. In this chain, cryotechnology plays a central, often underestimated role. Without reliable cryopreservation and safe cryotransport containers, CAR-T cell therapy in its current form would not be possible.
The CAR-T therapy process is highly standardized and subject to strict GMP requirements:
White blood cells (leukocytes) are removed from the patient using leukapheresis, from which the T cells are isolated. This so-called leukapheresis product must be processed or cryopreserved immediately.
As only a few specialized facilities worldwide can carry out genetic modification, the starting material often has to be transported over long distances - sometimes across national borders. This is where the Dry Shippers of the Consarctic® ASR+ series come into play: they keep the samples at temperatures below -150°C and are classified as non-hazardous, which enables international air transportation.
In the GMP laboratory, the T cells are provided with a viral vector that encodes the chimeric antigen receptor (CAR). The modified cells are then expanded in bioreactors until a therapeutic dose is reached. This process can take two to four weeks.
The finished CAR-T cell product is cryopreserved again - this time under the strictest GMP conditions in a controlled rate freezer. The BIOFREEZE® devices from Consarctic® offer the necessary reproducibility and complete batch documentation.
The cryopreserved product is again transported to the treating hospital in a cryocontainer. There it is thawed immediately before the infusion and administered to the patient.
There is no room for technical error in the CAR-T process chain. A single break in the cold chain can render the entire product unusable - and thus destroy the last treatment option for a seriously ill patient.
Temperatures must be kept below -150°C throughout transportation. The adsorption materials in the Consarctic® Dry Shippers safely bind the liquid nitrogen and ensure holding times of several days - even in the event of transportation delays.
Regulatory authorities such as the EMA or the FDA require complete documentation of transport conditions. Integrated data loggers record the temperature curve throughout transportation and provide proof that the cold chain was not interrupted at any time.
Every device used in the CAR-T process chain must be validated. Consarctic® provides the associated IQ/OQ documentation and ensures that all systems meet the requirements of the GMP guidelines.
Leading hospitals and pharmaceutical companies such as Roche and Bayer rely on the cryogenic products and services of Consarctic®. Our experience in working with manufacturers of cell and gene therapies makes us the ideal partner for the cryogenic infrastructure of the CAR-T process chain.
CAR-T cell therapy is just the beginning. With the development of new cell and gene therapies, the demand for high-quality cryotechnology will continue to grow. Consarctic® is continuously investing in the further development of its products and services to meet the increasing requirements of these revolutionary forms of therapy.
Are you interested in a cryogenic infrastructure for your cell therapy process chain? Our specialists will be happy to advise you on the optimal solutions for your specific regulatory and logistical requirements.