Phase 3 glioblastoma cell therapy clinical trial will utilize cloud-based cold chain management system
The evo® smart shipper from SAVSU Technologies will enable superior payload temperature stability and GPS location visibility during shipment of apheresis collections in the trial of a patient-specific, dendritic cell-based immunotherapy for glioblastoma.
In a phase 3 clinical trial of a patient-specific, dendritic cell-based immunotherapy for newly diagnosed glioblastoma, the evo® Cold Chain 2.0â„¢ live cell visibility platform, from SAVSU Technologies (NM, USA), will be utlized to ship apheresis collections. This device will ensure stable temperatures and allow GPS tracking of the samples on their way to the manufacturing facilities producing the immunotherapy. The ICT-107 trial (NCT02546102), sponsored by ImmunoCellular Therapeutics (CA, USA), will enroll up to 120 clinical sites in the US, Canada and Europe.
Marta Schilling, Vice President, Cell Therapy Manufacturing, commented, “We have been extremely pleased with the performance of the evo® Cold Chain 2.0â„¢ system for use in our phase 3 study. The unique uni-directional packout prevents errors in packaging and makes it very simple for our clinical sites to package the starting apheresis product for shipment to our manufacturing facilities. Validation of tight temperature stability in every shipment is critical, and we have not experienced any temperature or packaging deviations since switching to evo®. It is clear that an enormous amount of thought and testing went in to the design of the evo® system.”
Bruce McCormick, President of SAVSU Technologies remarked, “Our optimized technologies represent the next generation of integrated, cloud-connected cold chain technologies. It is rewarding to see the stellar real-world performance of evo® in a high volume, challenging application. We are committed to supporting ImmunoCellular Therapeutics and the regenerative medicine industry with disruptive products by driving a paradigm shift away from traditional, risk-laden cold chain practices based on the use of poor performing shipping containers and disconnected data systems.”
Safeguarding the cold chain is a critical step in commercializing regenerative medicine therapies. It is estimated that $15-35 billion is spent every year replacing products lost due to erratic storage temperatures. Listen to our podcast with BioLifeSolutions (WA, USA) CEO, Mike Rice, about the importance of appropriate biopreservation.