Development and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

by John M. Baust, PhD, William L. Corwin, PhD, Kristi K. Snyder, PhD, John G. Baust, PhD, and Robert G. Van Buskirk, PhD
Volume 15, Issue 1 (Spring 2016)

While playing an integral role in biotechnology and medicine, cryopreservation (CP) is often viewed as a “simple tool” and is overlooked as a critical and evolving component of cell and tissue bioprocessing. Despite this, cryopreservation serves as an enabling technology in numerous areas including the latest cell therapies. For example, over one third of the cells used in clinical trials are cryopreserved using the traditional methods, which in many cases yield suboptimal outcomes. Further, researchers still rely on the assessment of cell survival immediately post-thaw (within a few hours), and fail to account for the impact of cryopreservation-induced delayed-onset cell death (CIDOCD) which continues to impact survival from hours to days post-thaw. Interestingly, despite the fact that CP research remains in a growth phase that focuses on the role of the cellular molecular response to CP stress, these discoveries, and the resultant paradigm shift, have yet to filter into mainstream utilization. Given the crucial role of CP, coupled with other challenges needed to keep pace with modern biomedicine, we have embarked on a goal of developing a novel device and protocol designed to enable rapid, controlled, multi-sample, and high-throughput thawing in an effort to improve overall sample viability and function post-thaw. We have achieved this with the development of the SmartThaw™ device. Studies were conducted using human prostate cancer cell (PC-3) and human mesenchymal stem cell (hMSC) samples cryopreserved using standard, controlled-rate freezing protocols and then thawed with SmartThaw. Post-thaw survival results were equivalent or improved, as compared to traditional water bath approaches, depending on the freezing media utilized. All SmartThaw experiments were achieved in a clean, dry, sterile field with real-time monitoring of the sample thaw thermal profile. Study results suggest that SmartThaw outperforms traditional methodologies. Importantly, these investigations are providing new technologies and direction that are built on a cell/molecular foundation that helps accelerate research, technology, and procedure development initiatives in which CP serves as an enabling component. Further, improvements in standardized sample thawing devices and protocols may pave a path for increased use of cryopreserved cells in clinical applications that enable improved post-thaw viability, homing, biodistribution, and engraftment...

Baust JM, Corwin WL, Snyder KK, Baust JG, Van Buskirk RG. Development and assessment of a novel device for the controlled, dry thawing of cryopreserved cell products. BioProcess J, 2016; 15(1): 30–41.

Posted online April 7, 2016.