De-risk your cell therapy supply chain
From Donor enrolment, scheduling, sample collection through shipment of the cellular starting material, manufacturing and final infusion, TrakCel documents, integrates and orchestrates every aspect of the supply chain in a scalable, compliant and validated technology framework.
Any paper-based cell therapy supply chain quickly becomes inefficient and risk-prone due to shifting regulatory requirements and linear complexity as demand scales up and scales out.
A successful and scalable cell therapy supply chain demands standardised processes, automated electronic records, integrated temperature-sensitive logistics, real-time visibility and end-to-end traceability to ensure final product quality.
TrakCel combines proven technologies with a design-driven implementation to economically and effectively integrate and risk-manage your cell therapy supply chain.
Scale safely. Scale with confidence
Scaling production of autologous and allogeneic cell therapies presents a number of unique challenges driven by complex supply logistics and the need to scale out production either to multiple manufacturing sites or multiple ‘near patient’ centers.
A key challenge is the need to scale-out production of autologous cell therapy products for both multi-centric Phase III studies and for the supply of marketed products to clinical sites in multiple distributed locations, potentially within different regulatory jurisdictions.
· Remove geographic barriers with standardised processes
· Sample scheduling and collection, logistics and manufacturing
· Integrated bar-code and labelling enforces standardisation
· Integrated logistics reports includes temperature and location
With TrakCel’s personalised processes and automated workflows for all participants across the value chain, you can scale out, scale up and standardise everything from sample collection, logistics, manufacturing and ancillary sample testing through to final infusion.
Conditional logic workflows for every member of your supply chain including clinicians, logistics and manufacturing partners ensure standardisation and compliance with your product’s approved manufacturing development procedures.
· Conditional logic workflows
· Integrated alerts and notifications
· Enforce site and location-based activities with TrakZones
· One holistic solution to manage all supply chain partners