Abstract
In this chapter we consider the particular preservation storage procedures applied to a range of cell types used to produce cell-based medicines. Specifically, it deals with the scientific considerations for preserving each cell type and the kinds of cryopreservation protocols used to successfully preserve these different cell types. The cell types addressed include both those commonly in current use for patient treatment, such as whole blood and hematopoietic stem cells and also examples of new cell-based medicines including tissue progenitor cells (MSCs), (The use of the term Mesenchymal Stem Cell (MSC) has been hotly debated in the literature as it actually applies to several different cell types. The term “tissue specific progenitor cells” has been proposed as a more accurate term (Robey 2017) and where the abbreviation “MSC” appears elsewhere in this chapter it can be assumed this is a reference to Mesenchymal Stromal cells or the more generic term for this group of cell types Tissue-Specific Progenitor Cells (TSPCs).) tissue engineered constructs, CAR-T cells and pluripotent stem cells. However, the chapter does not consider the preservation and storage of organs or cells and tissues used in reproductive medicine. A second part of the chapter addresses best practice in meeting regulatory requirements for preservation and storage of both unfrozen and cryopreserved materials, including core requirements for the design of storage facilities. Also considered is best practice for packaging and shipment of cell-based medicines and their reception at the clinic and control within the hospital environment under pharmacy rules. The authors have used examples of regulatory documents primarily from the European Union and the USA, but also include reference to key international standards and WHO guidance.
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Abbreviations
- ACT:
-
Adoptive cell therapy
- ATMPs:
-
Advance therapy medicinal products
- B-ALL:
-
B-cell acute lymphoblastic leukemia
- BC:
-
Blood component
- BM:
-
Bone marrow
- CAR-T cell:
-
Chimeric antigen receptor T-cell
- CB:
-
Cord blood
- CFU-GM:
-
Colony forming unit-granulocyte/macrophage
- cGMP:
-
Current good manufacturing practice
- CIDOCD:
-
Cryopreservation-induced delayed-onset cell death
- CPA:
-
Cryoprotective agent
- DCs:
-
Dendritic cells
- DMSO:
-
Dimethyl sulfoxide
- DOCD:
-
Delayed-onset cell death
- EBMT:
-
European Society for Blood and Marrow Transplantation
- ECM:
-
Extracellular matrix
- EG:
-
Ethylene glycol
- EMA:
-
European Medicines Agency
- ESCs:
-
Embryonic stem cells
- FBS:
-
Fetal bovine serum
- FFP:
-
Fresh frozen plasma
- GCS-F:
-
Granulocyte colony-stimulating factor
- GDP:
-
Good distribution practice
- GF:
-
Growth factors
- GMP:
-
Good manufacturing practice
- GS:
-
Granulocytes
- GVHD:
-
Graft-versus-host-disease
- HCBCL:
-
Human cord blood cell leucoconcentrate
- HES:
-
Hydroxyethyl starch
- hESCs:
-
Human embryonic stem cells
- hiPSCs:
-
Human induced pluripotent stem cells
- hPSCs:
-
Human pluripotent stem cells
- HSA:
-
Human serum albumin
- HSC:
-
Hematopoietic stem cells
- LN2:
-
Liquid nitrogen
- LS-HP:
-
Liquid state hypothermic preservation
- MCR:
-
Mean cooling rates
- MMP:
-
Metalloproteinase
- MPCs:
-
Multipotent progenitor cells
- MSCs:
-
Mesenchymal stromal cells
- NC:
-
Nucleated cell
- OBC:
-
On board courier
- PBMC:
-
Peripheral blood mononuclear cells
- PBPCs:
-
Peripheral blood progenitor cells
- PBSC:
-
Peripheral blood stem cells
- PC:
-
Platelet concentrate
- PCTS:
-
Precision-cut tissue slices
- PSCs:
-
Pluripotent stem cells
- PVP:
-
Polyvinylpyrrolidone
- RBC:
-
Red blood cell
- RCC:
-
Red cell concentrate
- ROCKi:
-
Rho-associated kinase inhibitor Y-27632
- RT:
-
Room temperature
- SOPs:
-
Standard operating procedures
- SUC:
-
Sucrose
- TE:
-
Tissue establishment
- TECs:
-
Tissue-engineered constructs
- TSPCs:
-
Tissue specific progenitor cells
- TWEs:
-
Transient warming events
- U.S. FDA:
-
United States Food and Drug Administration
- UW:
-
University of Wisconsin
- WB:
-
Whole blood
- WHO:
-
World Health Organization
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Acknowledgments
Development of this chapter is facilitated by the UNESCO Chair in Cryobiology hosted by the Institute for Problems of Cryobiology and Cryomedicine of the National Academy of Sciences of Ukraine (http://www.cryo.org.ua) and supported by the Society for Low Temperature Biology Committee (https://www.sltb.info).
The authors thank the University Hospital Hradec Králové and the Charles University for financial support – supported by MH CZ–DRO (UHHK, 00179906) and Charles University grant projects SVV 260543/2020 and PROGRES Q40/06.
Dr. Olga Mykhailova is supported by a Post-doctoral Fellowship from the Canadian Blood Services.
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Acker, J.P. et al. (2022). Preservation and Storage of Cells for Therapy: Current Applications and Protocols. In: Gimble, J.M., Marolt Presen, D., Oreffo, R.O.C., Wolbank, S., Redl, H. (eds) Cell Engineering and Regeneration. Reference Series in Biomedical Engineering(). Springer, Cham. https://doi.org/10.1007/978-3-319-37076-7_68-1
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Preservation and Storage of Cells for Therapy: Current Applications and Protocols- Published:
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DOI: https://doi.org/10.1007/978-3-319-37076-7_68-1