Cryobags – Current Scenario and Future Trends

Since the 1980s, there have been significant advancements in the cryopreservation techniques used for storing stem cells, particularly hematopoietic stem cells and embryonic stem cells, which are essential in various medical applications, including regenerative medicine and biobanking. This can be attributed to the fact that the demand for biologics has been constantly increasing and driven by the rising demand for promising storage containers that safeguard the quality, viability, stability, and integrity of the preserved samples, cryobags, also known as cryopreservation bags, have emerged as the most reliable and safest choice for storage.

What is Cryopreservation in Biology?

Cryopreservation is the use of very low temperatures to preserve structurally intact living cells and tissues for a long period of time. Since ice crystals form during simple cooling or freezing, it is impossible to store stem cells and other viable tissues for an extended period of time despite their immense potential for use in basic research and numerous other medical applications. Moreover, damage to the membrane during freezing and thawing results in osmotic shock, which ultimately causes cell death. The aforementioned challenges prompted the researchers to explore the potential of cryobags that facilitate durable, transparent and flexible storage of analytes or biological materials at liquid nitrogen temperatures.

What are the Benefits of Cryopreservation Bags and Freezing Bags

There are various benefits of using cryobags over any other storage containers; some of these have been discussed below:

• Ergonomic– Cryobags 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.
• Stackability– Usually, flexible cryobags 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.

The below section highlights key features related to cryopreservation bags over any other storage container for preserving biologics, blood, cells or tissues.

• In order to withdraw samples into integrated thermal tube sections, the freezing bags are equipped with extra-long tubing.
• In comparison to many screw-top pharmaceutical vials, which must be opened to extract the product and pose a danger of contamination, a bag of cord blood is a considerably more effective option for thawing and injecting into a patient.
• Sample spike ports and sealed cryopreserved bags allow for safe transportation of aseptic items. They can easily be flushed to get rid of any unwanted items.
• Freezing bags are extremely customizable, allowing them to easily fit into a range of setups and meet several process requirements. This adaptability boosts operational capabilities.

Furthermore, an ideal cryobag must consist of the following qualities: 

• Closure integrity: In order to safeguard the quality of the sample during processing, storage, and transportation, the bag must be properly sealed.
• Sample stability: As a significant number of biobanked samples may be stored indefinitely, the method must be stable over a prolonged period of time.
• Easy access to material: To prevent contamination during sample withdrawal, functionally closed access systems must be implemented.

Cryobags: Current Market Landscape

Currently, over 30 firms claim to offer a variety of novel cryopreservation bags in order to cater to the rising demand for biopharmaceuticals.

The above figure presents the distribution of cryobags based on the type of analytes stored.

Presently, more than 70 cryogenic bags for biologic products have been / are being developed by industry stakeholders to enable long-term preservation of various materials. Further, as can be observed in the figure, cryobags can be used to store a wide spectrum of analytes. Cryobags for blood storage (31) capture the maximum share of the cryopreservation bags and freezing bags market, followed by bags aiding cell cultures storage (27), biologics (13) and tissues (13).  Notable examples of companies that provide more than three products (in alphabetical order) include American Durafilm, CellBios, Macopharma and OriGen Biomedical.

Trends that are Shaping Up Global Cryobags Market

Many stakeholders are undertaking initiatives to achieve greater durability in cryopreservation bags. In order to store biological material such as the CAR T cell therapy, specifically developed containers called cryopreservation bags are employed. Furthermore, in comparison to many screw-top vials, which must be opened to extract the product and pose a danger of contamination, a bag of cord blood is a considerably more effective option for thawing and injecting into a patient. Sample spike ports and sealed cryopreserved bags allow for safe transportation of aseptic items. They can easily be flushed to get rid of any unwanted items. Freezing bags are extremely customizable, allowing them to easily fit into a range of setups and meet several process requirements. This adaptability boosts operational capabilities. Undoubtedly, cryobags are effective in preserving biological materials, however, they still possess limitations in terms of long-term durability and robustness.

The above figure presents the distribution of cryopreservation and freezing bags, based on the application area.

Further, EVA (ethylene-vinyl acetate) is believed to undergo glass transition at temperatures lower than -15 degrees Celsius, which makes it fragile and susceptible to breakage, leaving EVA bags vulnerable to contaminations. This has prompted stakeholders to shift from conventional packaging materials to unparalleled packaging materials, such as polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP). It is worth highlighting that these materials are likely to be more widely recognized for exhibiting greater resilience for long-term applications. Given the inclination of stakeholders towards exploring novel innovative approaches that boost durability, we believe that the cryopreservation bags and freezing bags market size is likely to evolve at a rapid pace over the forecast period.

Concluding Remarks

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. In this context, it is worth mentioning that, according to Worldwide Network for Blood and Marrow Transplantation, around 90,000 hematopoietic stem cell (HSC) transplants are performed annually. Since HSCs are collected and cryopreserved before any transplant, the cryopreservation technique is a fundamental element of HSC transplantation, emerging as a key enabling technology in the field of regenerative medicines by offering stable, secure and extended cell storage.

For detailed insights about this industry, also check out our SAMPLE PAGES on Cryopreservation Bags and Freezing Bags Market