Standardizing the Sample Thawing Process

Thawing frozen biospecimens is an important step in the cryopreservation process. However, conventional methods of thawing can present a whole host of problems.

We spoke to Michelle Nemits, Chief Commercial Officer, BioCision, to find out how the ThawSTAR™ system automates the sample thawing process, and learn about some of the benefits that this can offer.

AM: Conventional thaw methods rely upon human interpretation. What are some of the problems this can cause?

MN: Current methods of thawing frozen biospecimens are entirely manual and include swirling vials in warm water baths, rolling frozen vials between hands to warm them up, or surprisingly, placing vials under the arm or in cups of warm water.  The main problem with these manual thawing methods is that they are subjective and require human interpretation of the end-point.  Most technicians want to thaw their specimen just to the point where a tiny ice crystal remains and the solid-to-liquid phase change is almost complete. This point can vary widely between technicians and have downstream effects on the specimen such as variability in recovery rates, viability rates, and proliferation.  If the vial being thawed contains a drug or cell therapy product, this human interpretation could have safety or efficacy ramifications.

AM: BioCision's ThawSTAR system automates the sample thawing process, how is this achieved?

MN: The technology carefully tracks vial temperature at the time of insertion and during the thawing process, as well as detecting the initiation of the solid-liquid phase change to optimize the thermal profile and deliver a consistent final sample temperature in the range of 0-5 degC.  In fact, because of this temperature monitoring, ThawSTAR can efficiently and reproducibly thaw vials right from LN2 storage as well as those equilibrated to -78C (dry ice temperatures).

AM: What benefits does ThawSTAR offer over conventional methods?

MN: As noted above, ThawSTAR first and foremost standardizes the thawing process and completely eliminates the subjective human interpretation of the end-point.  In addition, ThawSTAR's active light and sound feedback on the thawing process keeps the user apprised of the status of the thaw and reduces the risk of ruining vials of cells by e.g. leaving them floating in the water bath.  Also, the risk of contamination is high in conventional methods because communal water baths are not often cleaned and rolling vials between hands or placing in armpits are not sanitary procedures.  In GMP settings, water baths are generally avoided due to contamination potential and investigators often use e.g. dry bead baths.  Vial thawing in bead baths can take nearly 7 minutes (compared to ~2 min in a water bath or ThawSTAR) and this longer thawing time could cause additional damage to the cells.  The unique technology in the ThawSTAR provides a solid-state thawing process that is more efficient than bead baths and perfect for a GMP environment.

AM: What feedback did you receive during development?

MN: Feedback from beta testers was very positive.  We had a long list of beta sites to choose from and have so far worked with top-tier institutions like MD Anderson Cancer Center, Fred Hutchinson Cancer Research Center, Stanford University, UC San Francisco, Blood Systems Research Institute, UC Davis, Rutgers University and others.  Most testers were very pleased that ThawSTAR provided a uniform end-point comparable to what they would expect from a water bath thaw, and the post-thaw viability and recovery data validated this.  We also received comments regarding the ease of use, intuitiveness of the unit and positive feedback on the ability to use ThawSTAR in a GMP area and/or hood – areas where water baths are forbidden at worst, and problematic at best.

The following quotes came from beta testers and are found in our press release:

“…Our GMP protocols call for thawing of cells every 60 days from a Master Bank.  Use of a water bath within a GMP facility is highly discouraged due to  contamination concerns.  If one is employed, it must be thoroughly emptied and cleaned after every single use.  Incorporation of a ThawSTAR(TM) thawing system into our protocols allows us to streamline our workflow, recognize time savings, and enforce sterile operating conditions.”

-Helen Huls, Laboratory Manager in Pediatrics Research, MD Anderson Cancer Center

“…"BioCision is a very innovative company and once we heard about the new cell thawer, we were really eager to try it out for thawing PBMCs from our viral repository. When using a water bath to thaw there is always a risk of contamination, and we were keen to have a more reproducible cell thawing method. The ThawSTAR solves all of our concerns and we can even use it in the hood which improves our cryopreservation workflow.”

- Dr. Mars Stone, Viral Reference Lab and Repository Core, Blood Systems Research Institute

AM: Do you believe that the ThawSTAR will bring about standardization of biospecimen thawing?

MN: Yes. Similar to how our CoolCell® controlled-rate cell freezing devices quickly became the global standard for passive cell cryopreservation standardization, we expect ThawSTAR to become the new standard for controlled and reproducible thawing.  We are pleased at the response to this product and it validates our own beliefs that thawing is the last major gap in the cryopreservation process and researchers and clinicians are hungry for a solution.  BioCision has made it its mission to address inadequate methods that significantly impact progress of scientific research and discovery.  ThawSTAR is the latest in our product evolution to address a significant gap and provide researchers a solution to overcome these challenges.

Michelle Nemits was speaking to Anna-Marie MacDonald, Editor for Technology Networks.