Abstrakt
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.