Cryopreservation of biological materials plays a central role in numerous areas of pharmaceutical research, development and production. Especially in the production and application of modern biopharmaceuticals, such as cell and gene therapies, storage at extremely low temperatures has established itself as indispensable.
One major field of application is the long-term storage of cell-based therapeutics. For example, CAR-T cells - genetically modified immune cells that are used to treat certain types of cancer - require cryogenic storage in order to maintain their viability and therapeutic efficacy until they are used on patients. The cells not only have to be shock-frozen, but also stored under constant conditions for weeks or months and transported worldwide.
Stable cryogenic storage is also essential in the development and supply of viral vectors that serve as a means of transporting genetic information - for example in mRNA- or DNA-based platform technologies. The sensitive structures of these vectors can become unstable or lose their function even at low temperature increases. Precisely controlled storage protects their integrity and enables safe use in vaccine development or gene therapy.
Another key field of application is the safeguarding of so-called master cell banks. These cells form the basis for reproducible manufacturing processes, for example for monoclonal antibodies or recombinant proteins. As even minor genetic changes can affect the quality of the end products, deep-freeze storage over many years is necessary in order to fully preserve the original properties of the cell lines.
In addition, microbiological production strains - such as certain types of bacteria like Escherichia coli - are stored deep-frozen in order to make them available in identical quality for screening processes or protein expression when required. Frozen storage solutions are also used in preclinical research and clinical studies: blood plasma, biopsies and other human samples are often frozen to be used later for molecular analyses, biomarker studies or regulatory investigations.
A common feature of all these applications is the need to protect biological starting materials from environmental influences and loss of quality. Only a consistently stable and documented low-temperature environment can guarantee safety, comparability and therapeutic reliability throughout the entire product life cycle.
