What COVID Taught Us About the Benefits of Cryopreservation for Cell-Based Therapies

The COVID-19 pandemic significantly impacted various sectors of healthcare, including the blood and biotherapies field. It disrupted the supply and demand for blood and blood-derived cell products, presenting unprecedented logistical challenges that underscored the benefit of cryopreservation for cell and gene therapies (CGT).

According to the National Marrow Donor Program (NMDP), cryopreservation of hematopoietic progenitor cell (HPC) grafts was a last-resort option for many transplant centers before the pandemic. Only a small percentage (7.4%) of centers routinely used this method. As COVID-19 spread, logistical challenges like travel bans, flight delays, and border closures made it difficult to deliver fresh donor products, jeopardizing the delivery of allogeneic hematopoietic cell transplantation (HCT). This spurred many centers to expand utilization of cryopreservation, resulting in a dramatic increase in its use during the pandemic (90%).1

Cryopreservation has offered a safe and reliable treatment option for HCT, useful when fresh grafts might be less available.3 Donor cells can be cryopreserved and stored until needed, providing flexibility, and facilitating graft availability for the patient HCT, even if health status changed or logistical issues arose.

Benefits of Cryopreservation

The increased utilization of cryopreservation during the pandemic highlighted several key benefits:

Cryopreservation allows for the collection of donor cells in advance of the transplant, accommodating both patient and donor schedules. This flexibility is beneficial in managing unexpected delays or health changes in patients.

By enabling the storage of cells until needed, cryopreservation reduces the pressure of coordinating immediate fresh cell delivery, which can be particularly challenging amid travel restrictions or natural disasters.

Cryopreserved cells can be prepared and stored for future use, increasing the availability of matched donor cells and expanding access to treatments for more patients.

Advances in cryopreservation methods (including cryopreservation media) may improve the post-thaw viable recovery of cells, ensuring they remain effective for transplantation. This has made cryopreserved grafts a reliable alternative when fresh cells are not feasible.

Cryopreservation provides a safeguard against disruptions caused by natural disasters, ensuring that donor cells can be collected and stored safely until they can be transported to the transplant center.

A New Normal

While the demand for cryopreserved HPC products has decreased post-pandemic, the current rate of cryopreservation remains higher than pre-pandemic levels, averaging 23% higher in the past seven months for cryopreservation centers like the NMDP.2 This suggests an ongoing recognition of the benefit and utilization of cryopreservation, driven by the complexities of manufacturing cell therapy products and the necessity to navigate geographical challenges.

Conclusion

The COVID-19 pandemic has taught the life sciences field that cryopreservation is not just a backup plan but a beneficial component of cell and gene therapy manufacturing. Cryopreservation facilitates flexibility, continuity of care, mitigates logistical challenges, and offers a valuable tool for cell manufacturing. With post-pandemic usage higher than pre-pandemic, cryopreservation will continue to play a vital role in expanding patient access to treatments. As we move forward, continued collaboration and utilization of Biopreservation Best Practices will be of benefit to expand patient access and improve treatment outcomes in cell-based therapies.

References

  1. Worel, N., Ljungman, P., Verheggen, I.C.M. et al. Fresh or frozen grafts for allogeneic stem cell transplantation: conceptual considerations and a survey on the practice during the COVID-19 pandemic from the EBMT Infectious Diseases Working Party (IDWP) and Cellular Therapy & Immunobiology Working Party (CTIWP). Bone Marrow Transplant. 2023. https://doi.org/10.1038/s41409-023-02099-w
  2. Applewhite KY (May 2024) AABB News Magazine. Reconsidering Cryopreservation for HPCs. https://www.biolifesolutions.com/wp-content/uploads/2024/10/Applewhite-Reconsidering-cryopreservation-for-HPC-AABB-News-May-2024.pdf
  3. The National Marrow Donor Program. NMDP Cryopreservation Service. https://network.nmdp.org/-/media/project/nmdp/networkresourcecenter/pdfs/research/research-publications/np22393-cpe-cyro-study-2023-06.pdf?rev=98f9d1b6f2a4451385a0550db2b76259&hash=FF478881E40103E890FD169584270397

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