TrakCel sets new standards for the safe, effective and efficient administration of cell & gene therapies

TrakCel, a provider of integrated cell and gene therapy (CGT) orchestration solutions for the precise management, control and tracking of CGTs has today announced that its orchestration platform OCELLOS, has been selected to support five out of the seven autologous and matched allogeneic cell therapy products approved, or expected to be, this year.

To successfully navigate the therapeutic supply chain, CGT manufacturers need an IT portal to help them launch these FDA-approved products and ensure Approved Treatment Centres (ATCs) can administer the CGT safely and effectively.

The CGTs set for approval by the end of 2024, were listed by The Alliance for Regenerative Medicine (ARM) August 2024 Sector Snapshot. The manufacturers in question have chosen OCELLOS, a Salesforce-powered solution specifically designed for the cell & gene industry. It delivers a unique therapy process, connecting base modules and configurable forms, with real-time visibility of the progress of each personalized therapy through the supply chain, supporting supply chain efficiency and ease of collaboration with ATCs.

Dr Fiona Withey, CEO, TrakCel explains: “We’re committed to driving forward patient access to ground-breaking CGTs and are delighted to be supporting a growing number of manufacturers as they navigate the CGT supply chain and successfully launch their product.”

“Commercializing 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 standardize 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 standardization and ensure life-enhancing therapies reach the patients that so desperately need them.”

While CGT manufacturers are increasingly turning to OCELLOS, TrakCel has seen continued investment in custom-built IT portals to help facilitate product ordering and patient enrollment, and efficient orchestration of supply chain activities such as manufacturing and logistics.

As more CGT products are approved, TrakCel warns that an increasing number of custom-built platforms could overwhelm clinical site staff and be extremely expensive for each manufacturer to build and support, potentially limiting access to the therapy, and impacting patient safety.