GE Healthcare Advances the Delivery of Cell Therapies with new Thawing Technology.
GE Healthcare introduced the first in its VIA Thaw series, the VIA Thaw CB1000 for thawing large volumes of cell therapies cryopreserved in cryo-bags. This range of automated, dry thawing units provides users with control over the thawing of sensitive therapies, and addresses key challenges faced by cell therapy companies. Designed to overcome the multiple inconsistent elements in standard water bath thawing practice, the VIA Thaw series delivers a simple, reproducible and traceable recovery system that maintains cell viability to prevent loss of therapeutic effect.
With around 900 cell therapy clinical trials underway worldwide and a handful of products approved as treatments1, the emergence of cell therapies will potentially change the landscape of healthcare. However, maintaining cell potency throughout the manufacture and cryogenic cold chain (cryochain) of these treatments is a major challenge. Cell thawing is the final and least controlled part of the cryochain. 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 waterborne contamination. The collection and collation of data from thaw sites, often by paper records, also impedes therapy development. In 2015, the leading UK-based cell therapy organization, the Cell and Gene Therapy Catapult, identified these barriers to the commercialization of cell therapies and approached Asymptote (now part of GE Healthcare) to apply its expertise in cryochain technology to find the solution.
Commercially available from today, GE Healthcare's VIA Thaw CB1000, standardizes and streamlines the recovery of cryo-preserved samples with a system which captures a complete, auditable thaw record. Combining automation with dry conduction thawing, it enables the thaw endpoint to be precisely determined, and eliminates the contamination risk associated with water baths. Thaw profiles can be customized to every cell therapy sample and transmitted to thawers across multiple sites to ensure consistent sample thawing. All VIA Thaw CB1000 units have a'lock-down'option to limit the operator to a single pre-set profile and minimize the risk of error. Electronic data logging creates a record of each step in the thawing process and enables sources of variation to be identified quickly. All VIA Thaw units integrate with the GE's digital my.Cryochain platform, to standardize and audit thawing processes from any web-browser.
Ger Brophy, General Manager, Cell Therapy, GE Healthcare said: "As the number of cell therapies increases, GE Healthcare has been focusing on creating solutions that safeguard the manufacture and delivery of these therapies. The new VIA Thaw series will provide certainty in cell thawing, through an automated, dry process, and complete visibility over the thawing procedure. This technology has the ability to transform the final stage of cell therapy and help advance the industrialization and delivery of these potentially life-saving therapies."
VIA Thaw CB1000 is available now for research use in laboratory and clinical trial settings. The VIA Thaw SC2 for thawing cell therapies contained in 2 mL screw cap vials will be commercially available soon. Both units will be presented at the CAR-TCR Summit 2017 (5-8 September in Boston, MA).
The VIA Thaw series of automated thawers are intended for research use only. These are not medical devices and have not undergone medical device registration, clearance, or approval with any Regulatory Authority. The User is solely responsible for obtaining the appropriate IND/BLA/NDA, or equivalent approvals, for any clinical application.
More info: asymptote.co.uk/viathaw
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|Title Annotation:||READER SHOWCASE|
|Date:||Jan 1, 2018|
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