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Cryopreservation Just Got Better with Optibumin® 25

Published on 19 February 2025

Increase T Cell Recovery, Reduce DMSO, and Seamlessly Replace Plasma-Derived HSA

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Optimizing Cryopreservation with Animal-Origin-Free HSA Solutions

Struggling with cell viability after thawing? You’re not alone. Cryopreservation plays a crucial role in biomanufacturing, especially in developing cell-based therapies, where post-thaw viability can impact everything from functionality to clinical success. Traditionally, dimethyl sulfoxide (DMSO) has been the go-to cryoprotectant, but its toxicity and increasing regulatory scrutiny have scientists searching for safer, more effective alternatives.

At the same time, human serum albumin (HSA) derived from blood has been a key component of cryopreservation media, but batch-to-batch variability, pathogen transmission risks, and supply chain constraints make it less ideal for modern cell therapy workflows.

Now, there’s a better way.

Optibumin® 25 is the first human & animal-origin-free 25% recombinant HSA solution, providing a like-kind replacement for plasma-derived HSA while offering a significant reduction in DMSO concentrations without sacrificing T cell viability and expansion.

Optibumin 25: The Ideal Replacement for Plasma-Derived 25% HSA

Key Benefits of Optibumin 25 in Cryopreservation

Improved T Cell Viability and Expansion Post-Thaw

  • T cells cryopreserved with Optibumin 25 in CryoStor® CS10 (10% DMSO) demonstrated up to 2x expansion over 72 hours compared to to less than 1.5x  plasma-derived HSA​.
  • Similar improvements were seen in CryoStor CS5 (5% DMSO), with Optibumin achieving 1.6-fold and 1.25-fold expansions across two donors​.

Bar graphs comparing post-thaw fold expansion of cells from Donor 1 and Donor 2 after 72 hours with different albumin conditions, including HSA and Optibumin.

 

Significant Reduction of DMSO for Safer Final Formulations

  • High concentrations of DMSO are associated with toxicity and adverse reactions upon infusion in patients​.
  • By incorporating 5% or 10% Optibumin 25 into CryoStor formulations, developers can reduce final DMSO concentrations by up to 40%:
    • CryoStor CS10 (typically 10% DMSO) → Reduced to 6% with Optibumin
    • CryoStor CS5 (typically 5% DMSO) → Reduced to 3% with Optibumin

 

Table listing final DMSO concentrations in CryoStor CS10 and CS5 formulations with varying albumin concentrations. Incorporating Optibumin solutions reduces DMSO levels from 10% to 8% and 6% in CS10, and from 5% to 4% and 3% in CS5, improving the safety profile of cryopreserved T cells.

💡 Lower DMSO levels = improved patient safety without compromising T cell viability​.

Preservation of Critical Memory T Cell Phenotypes

  • Optibumin 25 preserved early memory T cell phenotypes like stem cell memory and central memory (Tscm and Tcm), crucial for CAR-T therapy durability and efficacy, maintaining their proportions 24 and 72 hours post-thaw​ compared to serum-derived HSA and no albumin controls.

Bar chart displaying T cell memory phenotype proportions (Tscm, Tcm, Tem, and Temra) at 24 and 72 hours post-thaw for cells cryopreserved in CryoStor CS10 and CS5 with varying albumin concentrations. Optibumin formulations preserve higher proportions of early memory phenotypes critical for CAR-T therapy efficacy.

Maintaining CD8+ T Cell Populations

  • A balanced CD4/CD8 ratio is essential for CAR-T manufacturing, as higher CD4/CD8 ratios can reduce therapeutic efficacy.
  • Optibumin 25 significantly preserved CD8+ cytotoxic T cell populations, which are critical for therapeutic potency, reducing CD8+ cell loss compared to plasma-derived HSA.

Bar graphs showing the percentage of live CD4+ (purple) and CD8+ (blue) T cells from Donor 1 and Donor 2 at 24 and 72 hours post-thaw, comparing different albumin conditions, including HSA and Optibumin.

 

Why Reducing DMSO in Cryopreservation Matters

Lower DMSO Levels Improve Patient Safety

DMSO is not just toxic to cells—it can also cause adverse reactions in patients when infused, including:

  • Nausea, vomiting, and abdominal pain.
  • Headaches and respiratory distress.
  • Severe allergic responses, including hypotension in sensitive individuals.

Regulatory agencies, including the FDA and EMA, strongly encourage lowering DMSO concentrations in cryopreserved cell therapies to mitigate infusion-related toxicities​. Optibumin 25 allows developers to reduce DMSO by up to 40%, significantly improving patient safety​.

DMSO is Cytotoxic at High Concentrations

While DMSO prevents ice damage, it is also a known cytotoxic agent, particularly at concentrations above 5-10%. Prolonged exposure can:

  • Induce apoptosis and oxidative stress in sensitive cell types.
  • Reduce post-thaw viability and impair cell proliferation.
  • Alter cell function, potentially impacting therapeutic efficacy.

Reducing DMSO concentrations helps enhance cell safety, ensuring higher viability and better therapeutic outcomes​.

Regulatory Trends Favor Lower DMSO in Biopharmaceuticals

As cell and gene therapies become more mainstream, regulatory bodies are placing greater scrutiny on cryoprotectant formulations.

  • EMA & FDA Guidelines recommend that biopharmaceutical manufacturers limit DMSO exposure in final formulations.
  • Commercialized cell therapies (such as CAR-T products) often require extensive DMSO washout procedures, adding cost and complexity to manufacturing.

Reducing DMSO concentrations early in cryopreservation simplifies downstream processing, improves regulatory compliance, and future-proofs cell therapy manufacturing​.

Conclusion: Reduce DMSO, Improve Cryopreservation with Optibumin 25

  • Significantly reduces DMSO concentrations—by up to 40%.
  • Improves T cell viability, expansion, and memory phenotype preservation.
  • Seamlessly integrates into CryoStor workflows with no process modifications.

Get the Application Note:  Enhanced Cryopreservation of T Cells Using Optibumin®, Recombinant Human Serum Albumin (rHSA)

Ready to Learn More?

Let’s talk! Reach out today to see how Optibumin 25 can help improve your cryopreservation process.

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Explore InVitria’s  Solutions

  • Optibumin® 25 (in bags) – A high-purity recombinant human serum albumin (rHSA) at 25% concentration, designed for seamless integration into CryoStor-based workflows. Optibumin 25 enables:
    • Up to 40% DMSO reduction for safer cryopreservation.
    • Enhanced T cell recovery and proliferation post-thaw.
    • Preservation of critical CAR-T memory phenotypes.

Footnotes

References

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  • Galli, E., et al. (2023). The CD4/CD8 ratio of infused CD19-CAR-T is a prognostic factor for efficacy and toxicity. British Journal of Haematology, 203(4), 564–570. https://doi.org/10.1111/bjh.19117
  • Li, R. U. I., Huang, J., & Wang, Y. (2019). Preservation of cell-based immunotherapies for clinical trials. Cytotherapy, 21(9), 943–957. https://doi.org/10.1016/j.jcyt.2019.07.004
  • Lin, Y., Raje, N. S., Berdeja, J. G., Siegel, D. S., Jagannath, S., Madduri, D., et al. (2023). Idecabtagene vicleucel for relapsed and refractory multiple myeloma: Post hoc 18-month follow-up of a phase 1 trial. Nature Medicine, 29, 2286–2294. https://doi.org/10.1038/s41591-023-02496-0
  • Lu, H., Zhang, Y., & Liu, P. (2024). Identifying new safety risk of human serum albumin: A retrospective study of real-world data. Frontiers in Pharmacology, 15, 1319900. https://doi.org/10.3389/fphar.2024.1319900
  • Madsen, B. K., Jensen, T., & Hall, S. (2018). Adverse reactions of dimethyl sulfoxide in humans: A systematic review. F1000Research, 7, 654. https://doi.org/10.12688/f1000research.16642.2
  • MacLennan, S., & Barbara, J. A. J. (2006). Risks and side effects of therapy with plasma and plasma fractions. Best Practice & Research Clinical Haematology, 19(1), 169–189. https://doi.org/10.1016/j.beha.2005.01.033
  • Meyran, D., et al. (2023). TSTEM-like CAR-T cells exhibit improved persistence and tumor control compared with conventional CAR-T cells in preclinical models. Science Translational Medicine, 15(690), eabk1900. https://doi.org/10.1126/scitranslmed.abk1900
  • Tian, Y., et al. (2017). Unique phenotypes and clonal expansions of human CD4 effector memory T cells re-expressing CD45RA. Nature Communications, 8(1), 1473. https://doi.org/10.1038/s41467-017-01728-5
  • S. Food and Drug Administration. (2024). Considerations for the use of human- and animal-derived materials in the manufacture of cell and gene therapy and tissue-engineered medical products. U.S. Department of Health and Human Services, Center for Biologics Evaluation and Research. https://www.regulations.gov/docket/FDA-2024-D-1244
  • Van der Walle, C. F., Shaw, E., & Davidson, L. (2021). Formulation considerations for autologous T cell drug products. Pharmaceutics, 13(8), 1317. https://doi.org/10.3390/pharmaceutics13081317

 

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