Technical and Quality Considerations in Cryopreservation Processes
EducationalCHALLENGES IN CRYOPRESERVATION FOR CELL & GENE THERAPIES
2026-05-27 | 10:00 AM - 10:35 AM | TPD Room
Abstract
Cryopreservation is a critical enabling technology for the long-term storage of cells, tissues, and advanced therapy medicinal products. Its success relies on the appropriate selection of cryoprotective agents (CPAs), the use of robust freezing technologies, and the implementation of well-controlled and validated processes.
This presentation provides a combined overview of the technical and quality-related aspects of cryopreservation. It will first review the different types of cryoprotective agents, including permeating and non-permeating CPAs, and describe their mechanisms of action in protecting biological materials during freezing and thawing. Key quality considerations related to cryoprotective agents will also be discussed.
The presentation will then provide an overview of the main technologies used in cryopreservation, with a focus on controlled-rate freezing systems. Particular attention will be given to the qualification of controlled-rate freezers, including installation, operational, and performance qualification (IQ/OQ/PQ), as well as critical aspects related to the validation of cryopreservation cycles. Process parameters, monitoring strategies, and documentation requirements will be addressed to ensure reproducibility, robustness, and compliance with quality and regulatory standards.
Overall, this session aims to provide attendees with a comprehensive understanding of both the scientific principles and the quality considerations necessary for the successful implementation of cryopreservation processes in regulated environments.
