Cryoport, Inc., the world’s leading cryogenic logistics company dedicated to the life sciences, today 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 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.”
How The Integrated System Works
iCAN is flexible and can be customized to address specific protocols. The system tracks patient dosing dates and frequencies, which are then cross referenced against the manufacturing capacities. The clinical site selects the patient and the system sends a dose ordering form and an authorization to release the patient-specific, serialized vial. The system simultaneously sends an order to the Cryoportal which alerts Cryoport to ship it via Cryoport Express Shipper to the manufacturer.
Once the manufacturing process occurs and the contract manufacturing organization (CMO) loads the therapy into Cryoport Express Shipper, it is sent to the clinical site. With patient safety always the top priority, the shipments are actively monitored continuously by Cryoport’s SmartPak II condition monitoring system which seamlessly communicates and records information with the proprietary Cryoportal to ensure temperature stability, package orientation and location are maintained at all times.
Ms. Joeckel stated, “We are very excited to bring a cohesive, seamless solution to the immunotherapy market. Cellular and gene therapies are changing the face of medicine and Cryoport is excited to be a vital part of the solution. As these clinical trials approach commercialization with global access, the ability to manage the holistic supply chain is critical. As Tom Whitehead, father of Emily Whitehead, the first child to be treated in a trial of T cell therapy for acute lymphoblastic leukemia, commented to me recently at the CAR T-cell Summit in Boston, ‘It’s not just a shipper, it’s a life.’ I don’t think there is a better way to summarize the importance of the solutions we bring to the market.”
About Cryoport, Inc.
Cryoport is a global provider of cold chain logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as immunotherapies, stem cells and CAR-T cells. Cryoport’s solutions are used by points-of-care, CRO’s, central laboratories, pharmaceutical companies, manufacturers, university researchers et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproductive medicine. Cryoport’s proprietary Cryoport Express Shippers, Cryoportal Logistics Management Platform, leading-edge SmartPak II Condition Monitoring System and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts.
Cryoport is dedicated to
- simplifying global cold chain logistics through innovative technology, unmatched monitoring and data capture and support, including consulting;
- delivering the most advanced temperature controlled logistics solutions for the life sciences industry; and
- providing vital information that provides peace of mind throughout the life of each logistics process
For more information: www.cryoport.com.
(Source: PR Newswire)