Focus On: TrakCel

TrakCel was the first provider of integrated cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy (CGT) products. It was established in 2012 by a group of co-founders with a background in temperature-controlled supply chain management services to the biotechnology industry. They were the first to identify the challenges of managing complex supply chains associated with both clinical and commercial cell and gene therapies.

These challenges are specifically due to the complex, fragile and extended nature of the CGT supply chain. This means that for these therapies to succeed at scale, robust supply chain management at an individual therapy level was essential. As a result, they started to develop the first cell orchestration software.

Today, TrakCel has now produced several generations of cell and gene therapy orchestration solutions and continues to develop them to meet future needs. It now has the largest number of live deployments supporting the broadest number of therapy classes in the industry. These solutions have become key as growth within the CGT sector advances in science and expedited clinical trial progression have expanded the number and variety of supply chain partners compared with previously approved therapies.

The ability to both report, track and highlight information that requires action is critical, especially in an industry where patient needs and costs of failure are high, and timelines are tight. OCELLOS by TrakCel, its lead cellular orchestration platform has been designed to be easily configurable to precisely match a therapy process. TrakCel built the solution on the Salesforce.com platform in order to facilitate a range of secure connectivity options to third party systems. TrakCel has decided to deliver these secure connectivity options via the MuleSoft powered OCELLOS Integration hub, including portals, accelerators and APIs, dependent on the data demands. This connectivity is vital to ensure that the platform has access to the data needed to drive real-time alerts and notifications of issues that could disastrously prevent the successful delivery of therapies.

TrakCel has recognized that the ability to access and share detailed data in an accessible format across the whole value chain is what makes OCELLOS so valuable to therapy developers, manufacturers and health care providers that deliver CGTs. As such, TrakCel continues to invest in integrations, support and training services and user centred design to ensure that OCELLOS continues to evolve to meet demands as therapies change or are added to the platform. This ensures the product remains relevant and user adoption and training does not become a burden over the lifespan of the product.

To continue to service the needs of the ever-growing CGT sector, TrakCel is increasing its investment to develop the organization. This includes continuing to grow its global teams in particular in the US and UK, and expanding commercial, customer facing and technical roles. This is in addition to TrakCel’s graduate recruitment program that looks to create a range of roles that help to build the STEM talent pool.

The TrakCel portfolio of products was broadened in January 2022 to include OCELLOS Lite, a configuration designed specifically for CAR-T therapies at the clinical stage. This product addresses the industry conundrum of the advantages of early adoption versus the cost and resource demands for deployment. TrakCel’s work with its customers showed that many clinical stages of CGT development could be simplified by deploying an orchestration system from the first patient. However, traditional systems supplied by the market were often either too complex and/or costly for early deployment or lacked function and capability once a therapy reached later stages of trials or approval. OCELLOS Lite was developed on the OCELLOS platform to facilitate rapid deployment but not limit the subsequent growth of the platform. This allows CGT developers to plan for success and commercial scale up from the outset with minimal risk.

The launch of OCELLOS Lite has been followed up with a number of integrations and partnerships with industry leading manufacturing, scheduling and patient hub services onto the full OCELLOS platform. TrakCel has managed to drive OCELLOS to become the first cell orchestration system to span the entire clinical through to commercial value chain, from patient registration and eligibility through to revenue recognition and follow up; in multiple languages, for multiple therapies, at any stage of the process, all from a single system.