MedCision, a leader in the automation of basic clinical processes, announced the ThawSTAR Cell Thawing Early Adopter Program for companies undergoing early cell therapy trials.
Clinical trials involving live cells represent a quantum leap in complexity and risk for sponsors and investigators. Trial success can be adversely affected by variations in sample handling and clinical trials with multiple clinical sites, investigators, and operators have a greater potential to introduce variability into the trial protocol. MedCision is eliminating obsolete technologies that have variability in thaw times, final vial temperature, and end points; all execution, effort, and money that goes into production of the therapy can be undone with errors in the last step prior to administration: thawing.
“MedCision is taking a new approach by putting the ThawSTAR platform in front of a select group of qualified companies to encourage increased use of standardized systems in pre-clinical research and clinical trials,” said Rolf O. Ehrhardt, M.D., Ph.D. CEO of MedCision. “Standardizing is an important yet often overlooked step, and we want to be sure that potential lifesaving therapies with proven, consistent and repeatable outcomes are reaching the clinic.”
Effective immediately, MedCision will offer up to 30 companies and institutions that wish to standardize and de-risk their clinical thawing effort free use of a limited number of ThawSTAR instruments for the duration of an early clinical trial phase. This special offer also includes full training and technical support.
To ensure optimal clinical outcome, every ThawSTAR platform in the Early Adopter Program will be programmed with a customized algorithm, specific to each unique cell therapy product. The algorithm technology takes into account an understanding that cell size, volume and choice of cryopreservative affect the thawing rate needed to preserve optimal function in a given cell type.
“Standardizing processes and the ability to produce repeatable results continues to remain a paramount part of clinical trials and cell therapy treatments,” said Samuel Kent, chief commercial officer of MedCision. “The ThawSTAR platform is a unique, controlled and automated cell thawing solution that reduces cell handling risk while eliminating water bath variability. By replacing detrimental water baths with a standardized and automated system, MedCision customers experience a scalable and customizable solution.