Will GMP Compliance Necessitate Standardized Cell Thawing?

Will GMP Compliance Necessitate Standardized Cell Thawing?

The strict requirements of a GMP cell culture facility emphasize the need for more standardized cell thawing. Image Credit: Wikipedia.org

Modern medicine is changing fast. As cellular therapies inch closer to late stage clinical testing and commercialization, manufacturing methods and technologies must keep pace with them. In BioProcess Online [1], Chief Editor Trisha Gladd speaks with regulatory T-cell specialist Dr. Karim Lee, as well as MedCision’s VP of Research and Development, Dr. Eric Kunkel, about how consistent, efficient cell thawing addresses the need to minimize variability in cellular products.
One of the challenges in working with cells is the issue of variability. Cells are inherently very sensitive to changes in their environment, especially the temperature changes that can occur during the thawing of cryopreserved cells.

Dr. Karim Lee, a scientist working for the Transplantation Research Lab at UCSF, explains the issue further. Her research group studies how regulatory T-cells moderate immune response to prevent tissue rejection after organ transplantation. Until recently, they used a water bath for their work, which is currently the most common method of thawing cryopreserved cells. Dr. Lee says that using the water bath created two problems, “first, the recovery and cell viability after thawing are quite variable; second, we don’t want to spend too much time for constant monitoring of a water bath to achieve temperature consistency and sterility due to FDA regulations.” GMP regulations specify that all instruments and reagents are closely monitored, and often preclude use of a water bath due to the risk of contamination. Her lab’s solution was to check out MedCision’s ThawSTAR® Automated Cell Thawing System.

The ThawSTAR system, as our regular readers know, is a water-free system designed to standardize cell thawing by automatically detecting solid-to-liquid phase changes. As Dr. Eric Kunkel explains, this allows the user to get a reproducible thaw temperature for different fill volumes in a cryovial, or for vials being thawed from different temperatures. Dr. Kunkel says this is achieved by “by efficient coupling of the heating units to the tubes with a pliable, inert material that bridges any small gaps and provides very good thermal contact…It’s basically a combination of solving some of the mechanics of heating a vial with a solid state unit, which up to this point, hasn’t been achieved, and using software and sensors to monitor and adapt to the process.”

The BioProcess editorial, which can be read here, goes on to describe the new cell thawing system in greater detail, as well as why such a system makes good sense for a clinical lab governed by GMP regulations. We all know necessity is the mother of invention. If one of the primary goals of emerging cell-based technologies is to lower process variability such that it no longer impacts cell viability and function, then adopting inventions such as the ThawSTAR will increasingly become more of a necessity than a convenience. The needs of the nascent cell therapy market may one day leave the common water bath behind, in favor of more standardization based technologies.

Reference:
[1] Gladd T. Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method? BioProcess Online. Jan. 2015.

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