Autologous cell and gene therapy processes start and end with the patient, so the transport and storage of these biologic materials pose complex logistical challenges. Depending on the severity of the patient’s illness, there may be limited opportunities for sample collection and, consequently, manufacture of the potential therapy. Furthermore, any variation in temperature or any interruption in the supply chain, can delay delivery and administration of the therapy to the patient. Irregularities in the cold chain may also affect clinical trial results by compromising data integrity as well as product efficacy and safety. To address these challenges, Cryoport and Database Integrations have launched an integrated solution to manage patient and manufacturer scheduling logistics at every stage of the supply chain for both clinical trial and commercialization processes.
Database Integrations’ Integrated Cell Therapy Automated Network scheduling platform randomizes the patient, schedules apheresis and plans manufacturing against clean room availability. The clinical site selects the patient and the system sends a dose-production ordering form and an authorization to release the patient-specific, serialized vial to the manufacturer. Simultaneously, an order is sent to the Cryoportal™ logistics management system, triggering Cryoport to load the vial into a Cryoport Express™ shipper to send to the manufacturer. Once the manufacturing process occurs, the shipper is scheduled for shipment to the clinical site for patient dosing.
Each step in the process transmits a data stream to facilitate the precise sequencing and timing of shipments, as well as continuous monitoring, recording and documentation of the condition of the biologic materials and their packaging. By coordinating disparate systems and stakeholders, the integrated solution reduces the potential for errors and delays, making the entire supply chain transparent and ensuring optimal cold chain transport and storage of these fragile biologic materials.
For more information about our integrated solution, contact us today.