049 Liquid nitrogen-free cold chain

Abstract

Manufacturing Practice (GMP) compliant cryogenic cold chain with particular application in regenerative medicine (RM). This cold chain will exploit Stirling cryocooler technology and will thus overcome the contamination issues associated with use of liquid nitrogen. Compared with conventional liquid nitrogen systems this equipment is more accurate, allows active control of the freezing process and can be integrated with robotic systems. GMP compliant devices are required at many stages in the cold chain for regenerative medicine: Autologous sourced cells: cryopreservation in the operating theatre of the source material for autologous treatments will optimise cell quality. Cells are either subsequently isolated and expanded (T cell therapies) or transplanted (ovarian tissue, parathyroid). This requires an operating theatre compliant controlled rate freezer with theatre compliant data collection and validation via a tablet. Allogeneic cells: master cell banks (MCB) and working cell banks (WCB), consisting of 50–500 cryovials need to be processed using a controlled rate freezer with minimum sample to sample variation and validation of the process parameters. Manufacturing: for many allogeneic and autologous treatments it will be necessary to cryopreserve the cell manufactured product, this may require cryopreservation in cryovials (up to 500); bags (5–500 ml fill volume) or cassettes (up to 2000 ml). High quality outcomes (functionality and viability) from the controlled rate freezers require controlled ice nucleation: Asymptote has identified suitable materials to achieve this which can either be added to the cryocontainers in the form of beads or may be coated on the freezing containers (cryovials, bags, etc). In all applications validated equipment for controlled cell thawing, especially of large cell volumes, is required by the end user. Current practice often involves water baths, which generally are not validated and also cannot be used in clean rooms. Data will be presented with a range of cell types processed in this new equipment Source of funding: Asymptote Ltd Conflict of interest: Director of Asymptote Limited jmorris@asymptote.co.uk