“Water bath thawing is the most common method for thawing cell therapies,” Philip Vanek, GE’s general manager of Cell Therapy Growth Strategy told Biopharma-Reporter.
“However, potential inconsistencies arise due to subjective determination of the thaw endpoint and risk of water-borne contamination, at the very point where the product is most valuable and most vulnerable.”
There is no easy way to record what is happening to a sample which makes it hard to know if procedures are all being followed identically, he continued, adding the process is labour-intensive, requiring staff to regularly complete contamination control procedures.
Therefore the firm has launched the VIA Thaw CB1000, an automated platform for the dry thawing of cryo-bags which Vanek told us overcomes these problems.
“VIA Thaw constantly monitors the sample temperature across multiple locations, records everything that happens in a comprehensive log and even takes a photo of the thawed therapy to prove it has been correctly handled.”
Furthermore, “the system requires no specialist skills to operate and delivers high recoveries of viable cells.”
The personalised medicine space is just beginning to blossom, with last week’s Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) breakthrough adding to a handful of cell and gene therapy products approved.
But the need for suitable GMP-compliant thawing systems has been highlighted for a number of years, and in 2014 the UK’s Cell and Gene Therapy Catapult partnered with Asymptote to develop a small benchtop thawing system which could accept different packaging options (vials and bags) and meet GMP requirements.
Asymptote is now part of GE Healthcare after it was acquired earlier this year and Vanek told us: “The first in the VIA Thaw series automated, dry thawers now provides cell manufacturers with the ability to control and monitor the thawing of sensitive cell therapies.”
This latest offering is now commercially available in the US and Europe for research use in laboratory and clinical trial settings, and pre-launch marketing activities with cell therapy companies have had a positive response, he had.