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

Abstract

This section describes a range of interventional therapies where cryopreservation plays an important role in delivery of cell therapies, and which are in wide use from a global perspective. The explosion in the development of advanced therapies and bioengineered constructs within medicine and biotechnology increasingly involves the in vitro manipulation of living cells and complex manufacturing processes. Successful cryopreservation is crucial to enable provision of reproducible starting cell stocks and cell-based products which can be thawed after quality and safety testing is completed and at the time they are needed by patients. Storage of large batch numbers of cells in a biologically stable state that can be recovered with consistent functional properties is crucial to delivering acceptable and effective cell-based medicines (Stacey et al. 2017a). While the technologies for isolation and manufacture of cell-based products have seen dramatic advances in recent years, biopreservation of these complex cell preparations remains an area for research and development and is a key road-block in the capability to deliver widespread access to the exciting potential benefits of these new medicines. In this chapter both nonfrozen live cell storage and cryopreserved storage methods are considered for a range of different cell-based medicines already in use and others that may form the basis of future medicines. While a detailed review of regulations applicable to storage and shipment of cells in different jurisdictions is beyond the scope of this chapter, we have considered the strategies to address regulatory considerations for the development of storage and shipment of cell-based products with reference to specific regulations in the European Union (EU) and the USA.