Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method?

By Trisha Gladd, editor, Pharmaceutical Online and BioProcess Online Follow Me On Twitter @pharmaonline and @bioprocessol

As we move into 2015, cell therapy as a viable and profitable market is becoming more of a reality, especially with the increased focus on unmet indications offering the potential for small companies to find their niche in the industry. However, one of the challenges with working with cells, at both the research and clinical level, is the issue of variability that can occur during the thawing of cryopreserved cells.

The most common thawing method today is the use of a water bath; however, this method can lead to issues with viability, contamination, and inconsistent results. Because of the sensitivity of the cell samples, it is nearly impossible to completely eliminate variability; however, with standardized handling practices, it can be lowered enough that it will not have an impact on the efficacy of a cell-based therapy.

The Risks Of The Water Bath

Dr. Karim Lee has been working in the Transplantation Research Lab at the Universityof California, San Francisco since 2008 studying the application of regulatory T cells in order to establish long-term acceptance of transplanted organs. Conventionally, we have used the water bath-based thawing protocol, says Lee. But we have two problems: first, the recovery and cell viability after thawing are quite variable; second, we dont want to spend too much time for constant monitoring of a water bath to achieve temperature consistency and sterility due to FDA regulations. Because all of our cell therapy products have to be manufactured in a clinical facility, which is a GMP facility, all the instruments and all the reagents have to be documented and closely monitored.

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Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method?