Not that long ago, cell and gene therapy (CGT) was mainly experimental. Developers dealt with one patient at a time, manufacturing a therapy at the same hospital where it would be used. Manual management and tracking processes were sufficient.
With more than 1,851 unique clinical trials underway in 2024, according the Alliance for Regenerative Medicine’s Sector Snapshot: August 2024 report, the supply chain has become complex. There are “more hospitals, more departments within each hospital, more healthcare professionals, more manufacturing sites, and more shipments between facilities,” Fiona Withey, CEO, TrakCel, tells GEN. “This increases the risk of the wrong product being dosed to a patient.”
That risk is exacerbated by a lack of standardization within the cell and gene therapy industry.
Standardization and automation
“Almost all personalized cell and gene therapies approved to date have been supported by their own software portal,” Withey points out. “This can lead to confusion among end-users, adding to already-heavy workloads, communication breakdowns, and potential security risks based on the large number of unique passwords a user may need to remember.
“While 100% standardization is unlikely to ever be fully realized because of product-specific processes, “systems should be designed to ensure that deviations from standards only occur when they are essential or add significant value to end-users.”
To address the need for standardization and automation, TrakCel developed OCELLOS. This “workflow-driven software solution was designed specifically for cell and gene therapies to improve consistency in therapy handling and data capture to ensure compliance with regulations,” Withey says. That includes using ICCBBA*-compliant chain-of-custody numbers and ISBT-128*-compliant labels as well as standard terminology and processes wherever possible.
The objective is to enhance visibility at every step in cell and gene therapy development and delivery by:
• Enabling chain-of-identity tracking for each product.
• Providing end-to-end audit-ready chain-of-custody reports for each therapy.
• Coordinating activities to, for example, provide healthcare providers with visibility into downstream manufacturing capacity.
• Automating supply chain activities, such as booking a courier to deliver cellular material collected from a patient.
• Using workflows to drive consistent processing of cellular material and capture all associated data across the supply chain.
Industry Advancement Board forums, hosted by TrakCel, benefit the entire industry by bringing together stakeholders from leading treatment centers, cell and gene therapy developers, and supply chain service providers to discuss pending issues. In addition to incorporating that feedback into OCELLOS, Withey says, “We plan to produce a freely available best-practice guide for the industry to help drive standardization.”
Although cell and gene therapy developers will undoubtedly continue to use multiple portals, efforts to standardize around key commonalities will go a long way toward streamlining workflow and reducing risks for stakeholders.
*(ICCBBA was originally known as the International Council for Commonality in Blood Banking Automation. ISBT originally was the International Society for Blood and Transport.)