New automated dry thawing units from GE Healthcare provide greater control.
With cell therapies now being approved by FDA and EMA and many additional products moving to late-stage clinical trials, this sector of the pharmaceutical industry is expanding rapidly. There are approximately 900 cell therapy clinical trials underway worldwide, according to GE Healthcare.
The commercial manufacture of these sensitive products can be quite challenging, however. Maintaining cell potency is essential throughout production, freeze-drying and transport—though this can be a challenge. The thawing of cells is the final step and often the most difficult, according to GE Healthcare. “The process is often carried out in water baths across multiple sites, with inconsistencies due to subjective determination of the thaw endpoint and risk of water-borne contamination. The collection and collation of data from thaw sites, often by paper records, also impedes therapy development,” the company said in a press release.
To address this issue, GE Healthcare developed a new automated system for thawing of large volumes of cell therapies that have been cryopreserved in cryo-bags. The VIA Thaw CB1000 is designed to overcome the multiple inconsistent elements in standard water bath thawing practice.
According to the company, the new system standardizes and streamlines the recovery of cryopreserved samples by capturing a complete, auditable thaw record. By combining automation with dry conduction thawing, the thaw endpoint can be precisely determined and the risk of contamination associated with water baths is eliminated. A ‘lock-down’ option ensures a single pre-set profile is used by the operator, which minimizes the risk of error. Sources of variation can be rapidly identified due to access to electronic data logging records for each step.
The VIA Thaw CB1000 is available for research use in laboratory and clinical trial settings. The company also plans to introduce a commercial unit – the VIA Thaw SC2 – for thawing cell therapies contained in 2 mL screw cap vials.