Development of a GMP cryogenic cold chain for clinical delivery of regenerative medicine therapeutics

Asymptote Ltd is proposing to develop the first GMP compliant cryogenic cold chain for the clinical delivery of regenerative medicine therapeutics. This project focuses on the key elements of the cold chain: controlled rate freezing of large volumes, short and long term frozen storage, and controlled thawing of large volumes. Cryopreservation of cells with high functionality on thawing is essential for cost effective cell production and geographically widespread clinical treatments, and this depends on accurate control of the freezing and thawing. This project will use Stirling cryocooler technology which has unique control ability and is able to meet the GMP requirement of regenerative medicine. It is intended to produce demonstrators for the key elements of the cold chain in collaboration with four centres developing different cell therapies.