Cryopreservation is the process of storing samples of cells, tissues, organelles or other biological constructs at extremely low temperatures in order to preserve them. It is a well-known fact that storage of biological components, such as stem cells and tissues, via simple cooling or freezing for an extended period of time is extremely difficult due to the formation of ice crystals. Even though, appropriately preserved biologics have immense potential for use in basic research and other medical applications, damage sustained by the membrane during freezing and thawing results in osmotic shock, which can ultimately lead to cell death. The aforementioned challenges have prompted researchers to explore the potential of cryopreservation / freezing bags that facilitate durable storage of analytes or biological materials at cryogenic temperatures (less than -65°C). Such advancements are essential for long-term storage of stem cells used in tissue engineering; the latter process holds a promise for restoration of tissue function, as well as the treatment of several known disorders for which a curative drug is currently not available. The global cryopreservation bags and freezing bags market is anticipated to grow at a CAGR of around 8%, till 2035, according to Roots Analysis. Driven by the rising demand for storing biologics and tissues, the cryopreservation bags and freezing bags market is expected to grow at a steady rate in the coming decade.
ROLE OF CRYOPRESERVATION / FREEZING BAGS IN HEALTHCARE
Cryopreservation has a significant role in blood, tissue and organ banking. However, with the rapid breakthrough in tissue engineering, cryopreservation of tissue-engineered products has become increasingly overriding in order to meet ready-to-use or single-use-solutions requirements in clinical applications and regenerative medicines. Additionally, with the rising popularity of cellular-based technologies and widespread use of cryopreservation techniques in biochemistry, molecular biology (food sciences, ecology, plant physiology, reproductive medicine) and other medical applications, it is becoming crucial to create better preservation techniques that can easily restore normal physiological functions.
It is worth mentioning that the biopreservation process aims to establish biorepositories with relevant biomaterials (such as cells, tissues, blood and body fluids, including plasma or serum) which are maintained in a stable format. While some biobanks (especially non-clinical ones) use mechanical freezers for storage, liquid nitrogen is one of the most reliable cryostorage medium. The temperature of samples kept in liquid nitrogen storage is known to be exactly -196°C and they are not prone to thermocycling, a risk that is always present in mechanical freezers or vapor nitrogen storage. Due to the infrastructure available for processing, freezing and storing of these container systems, blood bags are the preferred container for cell therapy biopreservation.
BENEFITS OF CRYOPRESERVATION BAGS
There are various benefits of using cryopreservation bags over any other storage containers; some of these have been discussed below:
- Ergonomic– Freezing bags are plug and play systems that are sterilized, assembled and prepared for use in freeze and thaw applications. A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation. This simple technique streamlines downstream processes and preserves valuable resources.
- Closed System – To ensure that there is no chance of contamination or leakage of liquid nitrogen used for freezing and storage of goods, single-use bags can be fully sealed and vacuum packed. On the other hand, twist-off caps on vials are unable to give this level of security.
- Error Reduction– Due to their ease of use, freezing bags require fewer operators, which lowers the possibility of handling errors. The sterile, closed systems protect the product and promote safe and reliable processing (with certified container integrity). The system is ready to use, which reduces operator workload while simultaneously guaranteeing the quality of the final drug product.
- Flexibility– Since single-use bag designs are compatible with all conventional and blast freezers, they can be integrated to existing facilities and equipment without the need for a substantial capital expenditure. Businesses that are hesitant to make changes due to the associated costs are likely to benefit from this versatility.
- Stack ability– Usually, flexible freezing bags are contained inside a more robust container. This bag-in-shell construction not only safeguards the expensive and valuable drug substances, but also enables stacking of the bags. This feature enables users to increase storage and shipping density while reducing facility footprint and optimizing transportation operations.
CHALLENGES ASSOCIATED WITH CRYOPRESERVATION BAGS
In this section, we have provided details related to the key challenges associated with cryopreservation bags.
- At the temperatures where cell suspensions are normally held, thermal transition of ethylene vinyl acetate (EVA) makes freezing bags that are made of EVA extremely brittle. As a result, during cryopreservation processing and storage, freezing bags become fragile and prone to cracking.
- Cell-freezing bag failure during the prolonged storage of cellular product is likely to result in contamination of contents, which could then spread to other items kept in the same liquid nitrogen tank.
- Extensive use of polyvinyl chloride (PVC) tubing to fill bags with samples can turn brittle at conventional storage conditions for biological constructs.
- Plasticizers are used to make PVC products flexible leach into the surrounding environment.
TYPES OF ANALYTES STORED IN CRYOPRESERVATION BAGS
A variety of biologics can be stored in cryopreservation bags. Based on the type of biologic fluid, we have classified type of analyte stored in the bags into four categories:
- Blood: According to the American Red Cross, in the US, around 6.8 million people donate blood annually and on a daily basis, approximately 29,000 units of red blood cells are required. Therefore, in order to store and preserve such enormous amounts of blood, single-use assemblies are a necessity. Additionally, successful and long-term preservation of biological specimens have been more effective at cryogenic temperatures (-196°C).
- Biologics: Gene therapy and cell therapy-based futuristic treatments fall under the category of advanced therapy medicinal products (ATMPs) and offer opportunities to individuals suffering from a variety of illnesses, including various types of cancers. Since gene-modified cell therapies rely on genetic alterations made outside of the body of a patient, the corresponding cells must be maintained in a stable state in an ex-vivo setting, for a predetermined amount of time. If the cell structure is to remain intact, long-term storage of cell products needs cryopreservation at temperatures lower than -130°C.
- Cell Cultures: The optimal preservation of stem cells is crucial for maintaining cell viability as they form an essential part of novel therapies and are thus extremely valuable. As a result, precautions must be taken to ensure cell survival prior to when they are further processed and potentially transmitted to a patient. Initially, the sample is stored at -4°C, and then it is frozen down to -156°C (when stored in the vapor phase) or -196°C (when stored in liquid phase).
- Tissues and Organs: Autopsies and surgical procedures are usually performed to collate human tissues and organs. It is important to highlight that length of duration of the surgery may have an impact on the degree of tissue degeneration and damage before collection. Usually, to completely freeze tissue samples, a cryovial of the sample is stored in liquid nitrogen or freezers at -80°C.
The cryopreservation of biomaterials has tremendous potential to tackle existing complexities in the pharmaceutical sector, specifically those related to survival rate and viability of living cells and complex tissues. Further, the ability to cryopreserve tissue-engineered products while preserving structure and function is required for large-scale clinical applications. Since engineered tissue alternatives are going through clinical trials, and with upsurge in demand for cultured cells and tissues on the horizon, the tissue engineering community is growing more concerned about supplying adequate quantities of these products to the market. Consequently, cryopreservation is the only known approach for the long-term preservation as it is capable to handle larger quantities of materials. Additionally, it is necessary to provide suitable cryogenic storage and shipment solutions in order to ensure an effective cryochain that links the laboratory to the clinical front line. Despite substantial progress in cryopreservation, research on how to optimize cryogenic freezing protocols is still underway. In fact, there is no single optimal temperature for cryopreservation as each type of sample requires specific storage conditions. Considering the current market trends and innovation landscape, we believe that, with a surge in morbidity, indubitably increasing demand for cell cultures with minimized loss of viability, rise in R&D activity and growing popularity of freezing bags over traditional storage containers, the cryopreservation bags industry is expected to witness steady growth in the coming years.
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