Cold Chain Delivery in Cell Therapies.

Cold-chain shipment (i.e. ultra-low cryogenic shipment) is a critical step to enable widespread patient access to cell therapies. These therapies often require multiple cryogenic transport steps, from sourcing cellular starting materials, to manufacturing, and ultimately to the final clinical application. Unlike conventional cold chain logistics, cryopreserved cell therapy shipments typically required much lower temperatures, involve high-value shipments (both in terms of financial cost of the therapy and the high patient impact incorrect shipment may have), and require a strict chain of custody and traceability.This chapter is intended to act as a guide for those developing or working with cell therapies and the wider cold-chain. Pros and cons of different temperature shipments are considered, from unfrozen down to LN2 temperatures. Typical shipping processes are considered, with a focus on key steps that must be taken that are not typical with standard, non-cryopreserved shipments. Finally the practicalities of developing a custom shipping system are considered, along with thoughts regarding the future direction of cold-chain processes as they become critical for ever more therapies, and more common within the logistics space.