TrakCel: Core activities within CARAT
TrakCel was founded in 2012 to address the rising demand in the developing Cell Therapy industry for de-risking and simplifying complex cell and gene-based therapies through a unique supply chain orchestration and management platform.
Over the years, TrakCel has grown from two founders to a team of 45 who are all based in Cardiff (UK). Most of these staff members work on product development, in particular on TrakCel’s technology platform COP (cell orchestration platform). This platform has three components: TrakWeb, TrakFlow andTrakPad which, in combination, allow the monitoring of complex supply chains for high value and high risk products. The technology has been tested and used in both clinical and manufacturing environments, tracking the progress of autologous therapies and has been deployed to cell therapy developers. Within CARAT, TrakCel will apply its technology to CAR T-cell therapies for the first time.
TrakCel will provide a pivotal role in the project developing and delivering a technology platform which will facilitate the adoption of CAR T-cell therapies ensuring process standardisation at all parts of the therapeutic supply chain and provide close monitoring and control when starting materials and final therapeutic products are shipped. TrakCel will also simplify the way in which the manufacture processes of these products are documented. In particular, TrakCel will be closely working together with Miltenyi integrating the TrakCel software with Miltenyi’s cell processing equipment, simplifying and introducing a significant portion of automation to the generation of batch documentation which is necessary for the scale-out of cell therapy products. Furthermore, TrakCel’s technology will be applied to a CAR T-cell therapy developed in the project. For this part in the project, TrakCel will be working closely together with treatment centres and manufacturing units to build a process map and to set up details for the complete supply chain, form scheduling a patient’s starting material collection, through to manufacture and the treatment with a CAR T-cell therapy.
Question & Answers from the TrakCel Team
The most exciting part of being involved in research projects such as CARAT is the potential to be one of a team that have helped to save the lives of people who are suffering through no fault of their own.
What expertise are you bringing to the project?
I bring a considerable amount of project management expertise to the project from both scientific and software industries. My skills within the project team are planning, coordination and communication to ensure all deliverables are met on time and to quality standards. I also facilitate the production of the deliverable reports and financial reports to the CARAT project team.
What are future challenges in the field of personalized medicine/cell and gene therapy?
The future challenges in my opinion are firstly the traceability for multiple treatments being delivered on a global scale currently being commercialized by multiple Pharma sponsors. Traceability within one organisation is daunting without considering the same clinical facilities hosting more than one Pharma business treating patients in parallel. Secondly challenges are faced with the cost of these personalized therapies which will pose a dilemma for some average wage patients unable to afford the treatment without health insurance. This in turn may change the way we think about public and private health care, especially in the UK, and force some families to dispose of major assets to receive the chance of a cure.
What is most exciting about being part of collaborative research projects in general and CARAT in particular?
The most exciting part of being involved in research projects such as CARAT is the potential to be one of a team that have helped to save the lives of people who are suffering through no fault of their own. It is also exciting to be working as part of a project that is in such a fast-developing scientific field with many researchers racing to the finish line for first commercial use of their therapies.
The collaborative and cross functional ethos this Horizon 2020 project engenders will drive advances in CAR-T treatments by bringing together the best minds in Europe which is the most rewarding aspect of the project.
Could your briefly describe the role and tasks of TrakCel within CARAT?
I will be taking full responsibility for TrakCel’s part in the project, this includes assisting with risk assessments, developing a supply cycle model for CAR-T therapies, process mapping and developing a usable interface between TrakCel’s software platform and Miltenyi’s manufacturing and analytical equipment. The focus of our work package is to examine the full supply cycle of these complex products and identify ways to increasing access to these therapies by simplifying the management of these products.
In your opinion, what impact does CARAT have? What is special about the project?
The collaborative and cross functional ethos this Horizon 2020 project engenders will drive advances in CAR-T treatments by bringing together the best minds in Europe which is the most rewarding aspect of the project.
What are “your” major achievements/results so far?
TrakCel has characterized a full exemplar supply cycle for a CAR-T therapy, identifying all activities and information required to successfully process a therapy and treat a patient. The areas of greatest risk in the supply cycle of CAR-T products has been identified and mitigation strategies for addressing these risks have been developed.
What are future challenges in this field?
The Industry needs to continue working to drive down the cost of goods associated with the manufacture of these products. A great tragedy of these curative therapies would not be failure, but success being too expensive for all to access these treatments.
Participation in CARAT will provide an exciting opportunity to engage with leading cell therapy developers, and the chance to be part of a project that will have a profound effect upon the quality of life of cancer patients.
Why is it important to develop technology platforms for personalized cell and gene therapy? What is the benefit?
Adoption of intelligent hardware and software systems should be used to automate the cell and gene therapy supply chain wherever possible, thereby reducing the risk of human error, as well as providing data security, traceability, and integrity.
Technology platforms afford levels of scalability not inherent in manual solutions, in accord with the challenges presented by the high data volumes, and increasing therapy throughput rates that we will face in the near future as the industry matures.
What are future challenges in the field of personalised healthcare?
Connecting together disparate systems and parties involved with therapy supply chains, and orchestration of an increasing number of personnel, materials, equipment and other resources in a complex ecosystem.
What is most exciting about being part of collaborative research projects in general and CARAT in particular?
Collaborative research projects provide the opportunity to harness a collective understanding of the problem domain, and to create a solution informed by a wide range of perspectives. Participation in CARAT will provide an exciting opportunity to engage with leading cell therapy developers, and the chance to be part of a project that will have a profound effect upon the quality of life of cancer patients.
I see cell and gene therapies becoming commercialised with systems such as TrakCel, Miltenyi’s products and courier systems at the heart of their success.
What are your key activities and major interests?
I’m responsible for the process design and technical requirements for the TrakCel solution that will be delivered for CARAT. This involves overseeing the development of a TrakCel configuration that will integrate with Miltenyi’s ClinicMACS Prodigy and MACSQuant machines
What motivates you?
Producing I.T. systems that make a difference in someone’s life, even in a small way.
How do you see this field unfolding/evolving in the future, e.g. what will be future business opportunities?
I see cell and gene therapies becoming commercialised with systems such as TrakCel, Miltenyi’s products and courier systems at the heart of their success.