TrakCel's cell and gene therapy orchestration solution for the management, control and tracking of CGTs has been selected to support five cell therapies this year.
This includes a range of autologous and matched allogeneic cell therapy products which have either already been approved, or are expected to be shortly.
TrakCel's IT solution, OCELLOS, is designed to assist CGT manufacturers to launch their therapies, while also ensuring that the product is administered safely and effectively.
The Salesforce-powered solutions connects base modules and configurable forms, allowing manufacturers to track the real-time progress of each personalised therapy through the supply chain.
CEO of TrakCel, Dr Fiona Withey, commented: “Commercialising CGT products is a complex and challenging process that requires close collaboration between manufacturers and ATCs. However, as more products are approved, ATCs are concerned this could lead to further proliferation of custom-made orchestration platforms, creating an additional burden on their staff that could potentially hinder the success of future new product launches.”
“Working with our Industry Advancement Board (IAB) we recognize that there is a growing need to standardise on one platform to help foster a consistent approach to capabilities and communication processes, training, workflows and use of terminology. OCELLOS is a proven technology ready to drive industry-wide standardisation and ensure life-enhancing therapies reach the patients that so desperately need them.”
TrakCel has observed an uptick in custom-built IT portals to facilitate CGT product ordering and patient enrollment, as well as supply chain management solutions for these therapeutics.
As more become available, TrakCel warns the industry that a consistent increase in the number of platforms of this nature could overwhelm clinical site staff, while being highly expensive for a manufacturer to buld and support.