Preservation and Stability of Cell Therapy Products: Recommendations from an Expert Workshop

Stacey, Glyn; Connon, Che J.; Coopman, Karen; Dickson, Alan J.; Fuller, Barry; Hunt, Charles J.; Kemp, Paul; Kerby, Julie; Man, Jennifer; Matejtschuk, Paul; Moore, H. D. M.; Morris, John; Oreffo, Richard O.C.; Slater, Nigel K.H.; Ward, Stephen V.; Wiggins, Claire J.; Zimmermann, Heiko

doi:10.2217/rme-2017-0073

Cited by 28 publications

(24 citation statements)

References 57 publications

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“…More recently RFID tags compatible with LN 2 storage temperatures and capable of being retro-fitted to standard cryovials have been introduced (Cryogatt, www.cryogatt.com). Ultra-cold-resistant chips are being developed which, when fitted within individual cryovials, could store not only a detailed thermal history but also detailed batch information, test results, and other relevant quality documentation [14]. …”

Section: Choice Of Container Systemmentioning

confidence: 99%

“…However, a recent prospective, multicentre surveillance study has suggested that factors unrelated to the CPA may be the cause of these reactions [45]. The debate surrounding the use of DMSO has led to a call for a proper assessment of the issues surrounding its use [14]. …”

Section: Choice Of Cpamentioning

confidence: 99%

“…Nevertheless, though a key component, cryopreservation often takes a back seat to other areas of bioprocessing when it comes to optimisation and control. This lack of attention to a key manufacturing process has been identified as a potential bottleneck in the future development of complex cellular therapy products [13, 14]. A thorough understanding of the cryopreservation process, including low temperature storage, is therefore vital for successful commercial manufacture of cellular therapies.…”

Section: Introductionmentioning

confidence: 99%

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Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies

Hunt¹

2019

Transfus Med Hemother

105

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The commercial and clinical development of cellular therapy products will invariably require cryopreservation and frozen storage of cellular starting materials, intermediates and/or final product. Optimising cryopreservation is as important as optimisation of the cell culture process in obtaining maximum yield and a consistent end-product. Suboptimal cryopreservation can lead not only to batch-to-batch variation, lowered cellular functionality and reduced cell yield, but also to the potential selection of subpopulations with genetic or epigenetic characteristics divergent from the original cell line. Regulatory requirements also impact on cryopreservation as these will require a robust and reproducible approach to the freezing, storage and thawing of the product. This requires attention to all aspects of the application of low temperatures: from the choice of freezing container and cryoprotectant, the cooling rate employed and its mode of delivery, the correct handling of the frozen material during storage and transportation, to the eventual thawing of the product by the end-user. Each of these influences all of the others to a greater or lesser extent and none should be ignored. This paper seeks to provide practical insights and alternative solutions to the technical challenges faced during cryopreservation of cells for use in cellular therapies.

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Section: Choice Of Container Systemmentioning

confidence: 99%

Section: Choice Of Cpamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies

Hunt¹

2019

Transfus Med Hemother

105

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“…Hydrogels are the most common materials used as the substrate for CMs. Hydrogels of gelatin‐methacrylate, hyaluronan, alginate, and gelatin have hydrophilic surfaces or specific moieties that have affinity to the receptors on the cell membranes . Hydrogels may be cast into a specific pattern, like paralleled channels, to allow for improved myofiber alignment and sarcomere maturity of CMs along the patterns .…”

Section: Application Of Biomaterials Engineering In CM Differentiatiomentioning

confidence: 99%

“…This strategy does not require cell dissociation and can gently remove undifferentiated PSCs to eliminate teratoma formation after transplantation in vivo. Undifferentiated PSCs are known to cause teratoma due to uncontrolled spontaneous differentiation . Antibiotic resistance genes can be used for purification of hPSC‐derived CMs with genetic modification.…”

Section: Remaining Challenges Of Using Pscs For MI Therapymentioning

confidence: 99%

Stem Cell Therapy of Myocardial Infarction: A Promising Opportunity in Bioengineering

Jiang

Shamul

et al. 2020

Advanced Therapeutics

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Myocardial infarction (MI) is a life‐threatening disease resulting from the irreversible death of cardiomyocytes (CMs). Stem cell‐based therapies have been studied for MI treatment over the last two decades with promising outcomes. Here, the past work in this field is critically reviewed to elucidate the advantages and disadvantages of treating MI using pluripotent stem cells (PSCs) including both embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), adult stem cells, and cardiac progenitor cells. Overall, PSCs (particularly iPSCs) have more advantages than the other cells for cardiac regeneration. However, the use of iPSCs is also facing critical challenges, which may be resolved by using biomaterials to engineer stem cells for reduced immunogenicity, improved immobilization/survival in the heart, and increased integration with the host cardiac tissue to eliminate arrhythmia. Biomaterials have also been applied in the derivation of CMs in vitro to increase the efficiency and maturation of cardiac differentiation. Collectively, a lot has been learned from the past failures of simply injecting intact stem cells or their derivatives in vivo for treating MI, and bioengineering stem cells with biomaterials may be a valuable strategy for advancing stem cell therapy towards its widespread application for MI treatment in the clinic.

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Cryopreservation of Immune Cells: Recent Progress and Challenges Ahead

Qi,

Jia,

Zhou

et al. 2024

Advanced Biology

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Cryopreservation of immune cells is considered as a key enabling technology for adoptive cellular immunotherapy. However, current immune cell cryopreservation technologies face the challenges with poor biocompatibility of cryoprotection materials, low efficiency, and impaired post‐thaw function, limiting their clinical translation. This review briefly introduces the adoptive cellular immunotherapy and the approved immune cell‐based products, which involve T cells, natural killer cells and etc. The cryodamage mechanisms to these immune cells during cryopreservation process are described, including ice formation related mechanical and osmotic injuries, cryoprotectant induced toxic injuries, and other biochemical injuries. Meanwhile, the recent advances in the cryopreservation medium and freeze‐thaw protocol for several representative immune cell type are summarized. Furthermore, the remaining challenges regarding on the cryoprotection materials, freeze‐thaw protocol, and post‐thaw functionality evaluation of current cryopreservation technologies are discussed. Finally, the future perspectives are proposed toward advancing highly efficient cryopreservation of immune cells.

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Preservation and Stability of Cell Therapy Products: Recommendations from an Expert Workshop

Cited by 28 publications

References 57 publications

Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies

Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies

Stem Cell Therapy of Myocardial Infarction: A Promising Opportunity in Bioengineering

Cryopreservation of Immune Cells: Recent Progress and Challenges Ahead

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