Manufacturers of Five Cell Therapy Products Select TrakCel’s OCELLOS Platform to Help Manage Patient Treatment

On Nov. 12, 2024, TrakCel, a provider of integrated cell and gene therapy (CGT) orchestration solutions, announced that its orchestration platform, OCELLOS, has been selected by manufacturers of five out of seven autologous and matched allogeneic cell therapy products approved or expected to be approved in 2024 to support the management of those therapies. TrakCel’s technologies enable the precise management, control, and tracking of CGTs.

An IT portal, such as OCELLOS, is needed to successfully navigate the CGT supply chain, as manufacturers require tools to help launch these FDA-approved products and ensure that approved treatment centers (ATCs) can administer the CGT safely and effectively, according to a company press release.

“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,” said Fiona Withey, PhD, CEO, TrakCel, in the press release. “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.”

A list of CGTs approaching regulatory approval by the end of 2024 are listed in a presentation given by The Alliance for Regenerative Medicine (ARM) in August 2024 (1). OCELLOS is a Salesforce-powered solution that was specifically designed for the CGT industry, according to TrackCel, which stated in its press release that the platform aims to deliver a unique therapy process by connecting base modules and configurable forms with real-time visibility showing the progress of each personalized therapy through the supply chain. This workflow is intended to support efficiency in the supply chain and ease collaboration with ATCs.

“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,” Withey stated in the press release. “OCELLOS is a proven technology ready to drive industry-wide standardization and ensure life-enhancing therapies reach the patients that so desperately need them.”

TrackCel also pointed out in its release that it sees continued investment in custom-built IT portals, even as CGT manufacturers are increasingly using OCELLOS. The company stated that these IT portals help facilitate product ordering and patient enrollment as well as efficient orchestration of supply chain activities, including manufacturing and logistics.

“As more CGT products are approved … 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,” TrackCel warned in its press release.

Reference

1. ARM. Sector Snapshot: The Emerging Value of Cell and Gene Therapy. alliancerm.org/sector-snapshot-august-2024, August 2024.

Source: TrakCel