Emerging Trends in Cryopreservation That Are Shaping Cell and Gene Therapy

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Erica Waller
Senior Product Manager
Cryo Automation and Stores
Azenta Life Sciences
Burlington, MA, USA

Cryopreservation, the process of preserving cells, tissues, and organs at extremely low temperatures, stands out as a pivotal technique in modern medicine. As we push the boundaries of what’s possible in regenerative medicine, cell and gene therapy, and organ transplantation, cryopreservation has emerged as a critical technology for maintaining the integrity of biological materials over extended periods. This process is crucial for preserving the functionality and viability of cells used in cutting-edge therapies, ensuring that treatments can be administered effectively even after long storage times.
As medical research progresses, several advancements in cryopreservation are being made to address the challenges of scalability, sample viability, and automation. Below, we explore seven key trends that are reshaping the future of cryopreservation and enabling the continued advancement of cell and gene therapy.

Trend 1: Scaling Cryopreservation for Clinical Trails

The rise of personalized therapies, such as CAR T-cell treatments, requires cryopreservation systems capable of handling diverse cell types while maintaining the integrity and viability of each individual sample. Managing these large, varied sample collections demands cryostorage solutions that are flexible, scalable, and designed to handle the challenges of personalized medicine.

In large-scale clinical trials, each patient's sample must be tracked and handled individually. For example, if a patient opts out of the trial, their sample must be easily located and removed without disturbing other stored samples. This requires systems designed for both precision and flexibility, ensuring that researchers can manage these samples efficiently while safeguarding their viability.

Moreover, the increased demand for personalized medicine means that cryopreservation systems must adapt to storing and managing a vast array of different cell types. As cell therapy trials scale, the logistics of managing these cells, especially in large multi-site trials, become increasingly complex.

Trend 2: Leveraging Automation for Efficiency and Safety

Automation is playing a transformative role in cryopreservation. By integrating robotics and automated storage solutions, labs can eliminate much of the human error associated with manual handling. Automated cryopreservation systems can retrieve samples with pinpoint accuracy while reducing the risk of accidental warming or contamination, thus safeguarding both researchers and the biological materials.

Automation also significantly enhances efficiency, especially as labs scale up from managing hundreds to thousands or even millions of samples. Hybrid storage systems, which combine manual and automated methods, are becoming increasingly common as organizations seek flexible solutions to manage varying sample volumes and research demands.

Automation can support regulatory compliance by ensuring consistent sample management and tracking. The systems log each interaction with a sample – reducing errors and maintaining precise control over temperature and storage conditions, which is crucial in clinical settings. Additionally, automated systems help mitigate the risk of exposure to hazardous materials, such as liquid nitrogen, by reducing the need for manual intervention.

Trend 3: Mastering Cold Chain Integrity

Managing the cold chain – the series of temperature-controlled environments through which cryopreserved samples move – is crucial for ensuring the integrity of biological materials during transportation. Disruptions in the cold chain can result in catastrophic damage to samples, especially for therapies where the quality of cryopreserved cells directly affects treatment outcomes.

Effective cold chain management requires meticulous tracking of temperature and environmental conditions from the moment a sample is frozen, through transport, and until it is thawed and used.

End-to-end traceability is now becoming standard practice, with advanced sensors and tracking systems that monitor temperature fluctuations in real time.

Effective cold chain management is crucial, especially when dealing with high-value samples for therapies like CAR T-cell treatments, where even small fluctuations in temperature can compromise sample viability.

Trend 4: Improving Sample Viability with Precision Tracking

Maintaining the viability of cryopreserved samples is critical, particularly for cell therapies that depend on the functionality of the preserved cells. Advanced tracking mechanisms that monitor exposure, temperature, and handling are crucial for ensuring the viability of these high-value samples.

For cell therapies, where the cost of treatment can exceed $500,000 per patient, ensuring that cells remain viable from cryopreservation to delivery is paramount. Precision tracking allows manufacturers to monitor each sample's location, temperature history, and overall condition, reducing the risk of compromised therapies and improving patient outcomes.

Increased automation also ensures higher sample security by limiting access to authorized personnel, further preserving sample integrity.

Trend 5: Mitigating Cell Damage from Transient Warming

One of the more subtle but significant threats to cryopreserved cells is transient warming, which occurs when samples are exposed to temperatures above the optimal freezing point during retrieval or handling. This can result in irreversible cell damage, even if the exposure is brief. When freezer doors are opened, not only are target samples exposed to warming, but so are nearby, non-target samples. Over time, this can reduce the viability of the preserved cells.

Robotic automation can significantly mitigate this risk by creating a controlled environment where only the target sample is exposed to warming during retrieval. A deeper understanding of transient warming’s effects is critical to minimizing damage and improving recovery rates.

Transient warming during cryopreservation retrieval can have profound effects on cell viability. Automated systems offer a solution by precisely locating and selecting samples without unnecessary warming of surrounding materials.

Trend 6: Ensuring Compliance with Robust Data Governance

Regulatory compliance is increasingly dependent on robust data governance systems that track every detail of the cryopreservation process. In the U.S., FDA regulations, such as 21 CFR Part 11, ensure the integrity and security of electronic records, which are used to monitor temperature and handling conditions. These regulations are critical for maintaining the traceability and compliance required for clinical-grade cryopreserved materials.

Proper data governance includes the implementation of audit trails, where temperature fluctuations, sample access, and handling logs are recorded with electronic time stamps. As more organizations rely on digital systems, ensuring these processes support compliance is essential to avoid regulatory pitfalls.

Trend 7: Championing Industry Standards

Finally, the establishment of industry-wide standards for cryopreservation is essential for fostering innovation and ensuring consistency across labs. Current standards, like the SBS standard for storage at -20°C and -80°C, help researchers use automated systems and laboratory instruments across various institutions. However, there is still a gap when it comes to standardized protocols for preservation at cryogenic temperatures.

Nonprofit organizations like the Standards Coordinating Body are bringing together relevant stakeholders to formulate and recommend solutions. A working group of the International Standards Organization (ISO) Technical Committee 276 on Biotechnology started discussions in 2022. If adopted, these standards will simplify workflows for cryobiologists following them to bring therapies to market more efficiently.

Looking to the Future of Cryopreservation in Cell and Gene Therapy

As the field of cell and gene therapy advances, the role of cryopreservation will continue to expand. From enhancing scalability to improving automation, addressing cold chain challenges, and pushing for industry standards, these trends will shape the future of medical research and patient care. By staying current with these innovations, organizations can ensure they remain at the forefront of this exciting frontier.

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About the Author

Erica Waller, Senior Product Manager, Cryo Automation and Stores
Azenta Life Sciences
Burlington, MA USA

Erica Waller is a senior product manager for cryo automation and stores at Azenta Life Sciences, headquartered in Burlington, MA, USA. She holds a BS in Mechanical Engineering from MIT and was a systems engineer for Brooks Automation (now Azenta Life Sciences) for several years prior to her current role. Today, she oversees the cryo storage and automation portfolio for Azenta Life Sciences

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