The SmartBio System for the Improved Preservation of Human Hematopoietic Stem Cells

CPSI Biotech is a technology development company focused on the design of devices and molecular modulation strategies in support of the biomedical and bioprocessing industries Through these efforts we have developed the PSN and SCN cryoablation systems for targeted ablation of various cancers including pancreatic cancer This unique medical device is now being tested at Johns Hopkins School of Medicine Given the favorable freezing and engineering characteristics as well as performance profiles compared to comparable systems CPSI has re tooled the PSN technology into a device SmartFreeze for the rapid and effective cryopreservation of human cells and tissues beyond what is possible today CPSI has also built a prototype device SmartThaw designed for the enhanced documentable and programmable dry thawing of human cell products This system is designed such that it has advantages over traditional water bath thawing such as operator software control design for unique thawing programs Furthermore SmartThaw Gen demonstrates a fold increase in post thaw viability of CHO cells compared to a standard water bath a result that argues well for improved post thaw outcome when applied to stem cells The SmartFreeze and SmartThaw devices collectively make up the SmartBio platform The unique features and documentable nature uniquely position the SmartBio for inclusion for cell processing in FDA approved stem cell INDs Given the potential of SmartBio under this project we will apply our extensive experience and knowledge base on the cell biology cryobiology and cryoengineering to develop a new class of devices and strategies to enable the rapid and controlled freezing and thawing of human hematopoietic stem cells hHSCs Phase Specific Aims are the following SA Develop the SmartThaw system for the improved thawing of hHSCs SA Couple the SmartThaw to the SmartFreeze system developing cell specific freezing and thawing profiles that result in optimal hHSC viability SA Test agents that target and ameliorate select cell stress pathways activated in hHSCs following the freezing and thawing process SA Analyze functionality and differentiation of hHSCs subsequent to the optimal freeze thaw process Phase will focus on device optimization developing an hHSC specific cryopreservation strategy for the SmartBio system performing homing studies and subsequent beta testing The overall goal of the SmartBio project is to improve hHSC post thaw outcome by over the current industry standard This proposal represents an integrative approach to product development coupling engineering and life sciences that will yield the first tandem operator controlled and documentable freezing and thawing systems specifically designed for the cell therapy arena CPSI Biotech is a biotechnology company that focuses on cell preservation and medical device development for medical and cell bioprocessing applications CPSI has developed a novel rapid freezing device and a thawing instrument for use in conjunction with frozen biologics that are stored in vials bags and straws The intent of this project is to further engineer these two prototypes and refine this technology platform into two innovative devices SmartFreeze and SmartThaw systems in support of the enhanced cryopreservation of hematopoietic stem cells and stem cell derived cell therapy products Data show that SmartThaw is up to three times more effective than the current state of the art Finally CPSI has the support of two major cell device distributors one of whom is currently testing the SmartThaw device for possible future distribution a key development in the few months prior to submission that argues well for future commercial potential