Preservation and Storage of Cells for Therapy: Current Applications and Protocols

Acker, Jason P.; Bondarovych, Mykola; Brunotte, Ricarda; Buriak, Iryna A.; Fuller, Barry; Glasmacher, Birgit; Goltsev, Anatoliy; Gregor, Jiří; Gryshkov, Oleksandr; Herrity, Kieran; Honegrová, Barbora; Hunt, Charles J.; Jandová, Miroslava; Johnstone, Brian H.; Kilbride, Peter; Lánska, M.; Mann, Jennifer; Měřička, Pavel; Musall, Kelsey; Mutsenko, Vitalii; Mykhailova, Olga; Petrenko, Yuriy; Radocha, Jakub; Sherry, Aubrey M.; Stacey, Glyn; Štěrba, Lubomír; Vokurková, Doris; William, Nishaka; Woods, Erik J.

doi:10.1007/978-3-319-37076-7_68-1

Cited by 2 publications

(4 citation statements)

References 331 publications

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“…The establishment of successful cryoprotectants and suitable storage may take considerable development time and that will need to be factored in. 22 , 23 …”

Section: The Key Steps In Manufacture Of Cell‐based Medicinesmentioning

confidence: 99%

“…The establishment of successful cryoprotectants and suitable storage may take considerable development time and that will need to be factored in. 22,23 At the point of entering clinical trials, it is crucial to have key critical manufacturing controls in place to assure the quality and safety of the production cell substrate and raw materials (reagents and consumables); in addition to which, these key controls should include in-process control and product release.…”

Section: The Ke Y S Teps In Man Ufac Ture Of Cell-ba S Ed Med Icine Smentioning

confidence: 99%

“…This will include those materials added to promote sustained viability in both cryopreserved and non‐frozen cell products. The establishment of successful cryoprotectants and suitable storage may take considerable development time and that will need to be factored in 22,23 …”

Section: The Key Steps In Manufacture Of Cell‐based Medicinesmentioning

confidence: 99%

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Translating stem cell research into development of cellular drugs—a perspective from manufacture of stem cell products and CMC considerations

Zhang¹,

Stacey

2022

Cell Proliferation

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The development of human pluripotent stem cell (PSC)‐derived medicinal products has been gathering steam in recent years, but the translation of research protocols into GMP production remains a daunting task. The challenges not only reside with the nature of cellular therapeutics but are also rooted in the general inexperience in industry‐scale production of stem cell products. Manufacturers of PSC‐derived products should be aware of the technical nuances and take a holistic approach toward early planning and engagement with their academic partners. While not all issues will be readily resolved soon, the collective knowledge and consensus by the manufacturers and key stakeholders will help to guide rapid progression of the field.

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“…The establishment of successful cryoprotectants and suitable storage may take considerable development time and that will need to be factored in. 22 , 23 …”

Section: The Key Steps In Manufacture Of Cell‐based Medicinesmentioning

confidence: 99%

Section: The Ke Y S Teps In Man Ufac Ture Of Cell-ba S Ed Med Icine Smentioning

confidence: 99%

See 1 more Smart Citation

Translating stem cell research into development of cellular drugs—a perspective from manufacture of stem cell products and CMC considerations

Zhang¹,

Stacey

2022

Cell Proliferation

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“…The availability of well-established cell lines like the NK-92 line, together with better automation and standardization of expansion and cryopreservation parameters, offers hope in overcoming these challenges. Current methods in cell therapies more generally use around 1˚C/min cooling rates, with Dimethyl sulfoxide (DMSO) and DMSO-free cryoprotectants common [9,18]-no common cryopreservation strategy exists for these cells between different groups.…”

Section: Introductionmentioning

confidence: 99%

Successful expansion and cryopreservation of human natural killer cell line NK-92 for clinical manufacturing

Lee,

Joo,

Lee

et al. 2024

PLoS ONE

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Natural killer (NK) cells have recently shown renewed promise as therapeutic cells for use in treating hematologic cancer indications. Despite this promise, NK cell manufacturing workflows remain largely manual, open, and disconnected, and depend on feeders, as well as outdated unit operations or processes, often utilizing research-grade reagents. Successful scale-up of NK cells critically depends on the availability and performance of nutrient-rich expansion media and cryopreservation conditions that are conducive to high cell viability and recovery post-thaw. In this paper we used Cytiva hardware and media to expand the NK92 cell line in a model process that is suitable for GMP and clinical manufacturing of NK cells. We tested a range of cryopreservation factors including cooling rate, a range of DMSO-containing and DMSO-free cryoprotectants, ice nucleation, and cell density. Higher post-thaw recovery was seen in cryobags over cryovials cooled in identical conditions, and cooling rates of 1°C/min or 2°C/min optimal for cryopreservation in DMSO-containing and DMSO-free cryoprotectants respectively. Higher cell densities of 5x107 cells/ml gave higher post-thaw viability than those cryopreserved at either 1x106 or 5x106 cells/ml. This enabled us to automate, close and connect unit operations within the workflow while demonstrating superior expansion and cryopreservation of NK92 cells. Cellular outputs and performance were conducive to clinical dosing regimens, serving as a proof-of-concept for future clinical and commercial manufacturing.

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Preservation and Storage of Cells for Therapy: Current Applications and Protocols

Cited by 2 publications

References 331 publications

Translating stem cell research into development of cellular drugs—a perspective from manufacture of stem cell products and CMC considerations

Translating stem cell research into development of cellular drugs—a perspective from manufacture of stem cell products and CMC considerations

Successful expansion and cryopreservation of human natural killer cell line NK-92 for clinical manufacturing

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