Cryoport has announced the integration of its proprietary logistics technology, the Cryoportal™, with Database Integrations, Inc.'s Integrated Cell Therapy Automated Network (iCAN) scheduling platform. The integration of these two platforms is designed to solve the challenges of manufacturing, distribution and global supply chain planning for the clinical development and commercialization of cell and gene therapy products.
Cell and gene therapy processes start and end with the patient, requiring extensive and finely-tuned planning. Whether it is an autologous treatment (where the patient's cells are used to manufacture doses specific to that patient) or an allogeneic treatment (where patients receive cells originally collected from others) the overall logistics process poses specific challenges associated with the scheduling, storage and transporting of biologic commodities used in cell and gene therapy programs, especially the information appertaining thereto.
Steve Littlefield, President of Database Integrations said, "Seamless integration with Cryoport's Cryoportal™ management platform is critical to ensuring rapid and efficient scheduling, manufacture and transport of cell-based therapies. Cells are procured from the patients and must be immediately processed. Because many of these patients are very ill, there may be only one chance to obtain the sample and manufacture the potential therapy. In addition, cell degradation begins immediately, and there may be fewer than 48 hours to transport the cells to the manufacturing facility."
Tamie Joeckel, Senior Vice President of Client Services for Cryoport, stated, "Accurate scheduling, processing, logistics and information are crucial to successful outcomes for patients. In most clinical and commercial supply chains for biologic commodities, the process is linear with the major focus on temperature stability, "chain of condition," and "chain of custody." For cell and gene therapy programs, many of the standardized processes do not support the program's requirements. The supply chain for these treatments is circular or closed – not linear - and strict distribution timelines must be coordinated with collection, manufacturing and patient schedules on both ends of the process."
As a pioneer in immune-based therapies for the treatment of brain and other cancers, ImmunoCellular Therapeutics, Ltd (NYSE MKT: IMUC) suggested the integration project. Anthony Gringeri, Senior Vice President, Strategic Resources at ImmunoCellular stated, "As a client of both Cryoport and Database Integrations, we saw there were efficiencies to be gained in overall scheduling and coordination with an integrated solution. Having an end-to-end, system-managed workflow eliminates the potential for manual data entry errors and provides better visibility from the clinical and manufacturing sites and vital information regarding the condition of the therapy at every stage of logistics."