Advanced Therapy Medicinal Products (ATMPs) represent a paradigm shift in medicine. Instead of a standardized drug that works the same for all patients, ATMPs are highly individualized therapies that are tailored to the individual patient. The three main categories are gene therapeutics, somatic cell therapeutics and tissue-engineered products.
What all ATMPs have in common: They consist of living cells or biologically active material that loses its effectiveness within hours to days at room temperature. Cryopreservation is therefore not only a logistical advantage, but a fundamental prerequisite for the successful production, transportation and clinical application of ATMPs.
In this article, we show what special requirements ATMPs place on cryotechnology and how Consarctic® supports ATMP manufacturers and treating clinics with customized solutions.
In autologous therapies (e.g. CAR-T), biological material is first taken from the patient - typically blood, from which the T cells are isolated. This starting material often has to be cryopreserved and sent to the manufacturing laboratory if the collection and production take place at different locations.
During the multi-stage manufacturing process, intermediate products are produced that need to be cryopreserved - for example, expanded cell populations that are intended for later genetic modification.
The finished ATMP product is cryopreserved to extend its shelf life. The shelf life of CAR-T cells is only a few hours at room temperature, but theoretically unlimited at -196°C. The controlled freezing process in a controlled rate freezer such as the BIOFREEZE® is crucial for cell viability after thawing.
The transportation of a cryopreserved ATMP from the manufacturing site to the treating hospital is the most vulnerable phase of the entire process. A temperature-sensitive ATMP cannot be reproduced - it is a unique specimen that has been produced for a specific patient.
In the EU, ATMPs are subject to Regulation (EC) No. 1394/2007 and must be approved centrally by the European Medicines Agency (EMA). The GMP requirements for ATMPs go beyond those of conventional pharmaceuticals:
Consarctic® has established itself as a reliable partner for ATMP manufacturers and users. Our portfolio for the ATMP sector includes
With each new ATMP approval, the need for qualified cryoinfrastructure grows. Investing in the right technology is not an optional measure - it is the prerequisite for ensuring that the most promising therapies in modern medicine reach their patients safely and effectively.
Do you develop or process ATMPs and need GMP-compliant cryogenics? Our specialists will advise you on the regulatory and technical requirements and develop a solution that supports your approval.