It is but one step in the multi-stage process of delivering the exciting new cellular therapies now coming onto the market today—but it is an important one: thawing the cryogenically preserved cells. One of the common development routes of the cellular therapies is autologous cell extraction, genetic manipulation in a bioprocessing facility, and reinfusion to the patient. Prior to reinfusion, the therapy is commonly delivered in a cryogenic state, and according to Phil Vanek, GM for cell therapy at GE Healthcare, a water bath is a common method of thawing. “The water bath does not lend itself to a low-risk, repeatable process in the workflow of the therapy,” he says. “Now, there is a way to maintain quality assurance with an automated, 100%-digital device that logs all relevant data.”
The device, the VIA Thaw CB1000, is a benchscale unit into which an operator places the cryobag by which the cellular therapy is usually delivered. Thawing occurs through conduction with a heat sink. A thawing profile can be developed and customized to each type of cellular therapy, and the device has a ‘lock-down’ option to option to limit the operator to a single pre-set profile and minimize the risk of error. Datalogging is integrated with a data-collection system, my.Cryochain, to provide auditable records of each application.
The CB1000 is the first of what is expected to be a series of thawing units with different capacities; a version designed to handle 2-ml vials is in the works. All that being said, GE Healthcare notes that the Via device is suited, at this time, only for research purposes clinical trials, and not as a GMP-validated production unit.
Via and my.Cryochain are brands originally developed by Asymptote, a UK company that GE acquired last spring. Asymptote, in turn, works with the Cell and Gene Therapy Catapult, a private-public partnership in the UK advancing the science in this field. Earlier, GE Healthcare acquired Biosafe SA, a supplier of integrated cell bioprocessing systems, and participated in setting up the now-independent Vineti, Inc., an IT company that seeks to orchestrate the entire cellular-therapy process, from intaking patients to providing reimbursement assistance. Vanek notes that it would make sense for Vineti’s network to interface with GE Healthcare’s my.Cryochain, but that depends on Vineti’s future actions.