Customizable Automated Thawing Device Series for Cryogenic Vials
The vial thawing protocol in the cell therapy industry is an unstandardized and variable process. Biocision identified clinical tools for pharmaceutical, biotechnology, and other healthcare industries to standardize and automate. The first platform to transform and automate the 40+ year conventional water bath thawing process was the ThawSTAR. Such a device is convenient in a GMP setting where water baths are generally avoided due to the potential contamination risk.
BioCison tasked Gener8’s engineers to architect, and develop a low-cost instrument to replace existing water bath solutions. Our integrated end-to-end design to manufacturing capabilities enabled the customer to go from proof-of-concept to Beta testing units in only four months and with early low- to mid-manufacturing in six-eight months.
Challenges
- Inconsistent thawing times can lead to lost cell cultures or reduced survivability.
- The water bath technique for thawing cells requires the user’s subjective determination of the thawing end-point.
- The user must visually estimate the size of the remaining ice by looking through the vial, which labels on the vial can complicate.
- Excessive warming time can cause the cells to metabolize the toxic cryo-solution, reducing cell viability and population.
- Careless motion of the cryovial during thawing could contaminate the cell culture from water becoming entrained in the cap threads of the cryovial.
- Inconsistent thawing times can compromise comparative analyses of cell cultures, corrupting the survivability fraction from one culture to another.
Solutions
- Gener8 engineered and manufactured a simple, easy-to-use, fully solid-state heating instrument that mirrored the heating profile of a water bath.
- A study by UCSF Diabetes Center and Transplant Surgery observed improved cell viability with the ThawSTAR instrument compared to the conventional water bath method.
- Comparative data has been obtained for various cell types, and the ThawSTAR instrument showed equivalent cell recovery and viability compared to a water bath.
- The ThawSTAR instrument eliminated contamination concerns and streamlined workflows, reducing cost and time while improving sterile operating conditions.
