Cell therapies are changing the landscape of clinical care, and their temperature-related vulnerability has made continuous cold chain management even more critical in the delivery of treatments to patients.
Cold chain management comprises three key phases: cooling, storage, and thawing. Thawing errors for a potentially lifesaving therapy could compromise treatment efficacy and may have significant impact on patients, costs, and a product developer’s reputation.
This guide to cell thawing reviews the science of thawing using conventional, slow freezing approaches. Topics include how cell thawing processes have evolved into the techniques applied today, the biological and physical effects of key components and metrics (e.g., ice structure, and temperature changes rates), evaluations from scientific literature, and a consideration of the interactions between cooling and warming rates related to cell and gene therapies. Ice-free cryopreservation, also called vitrification, is a specialized method unsuitable for most cell therapies and cryobags and is not considered here.