The supply chain for autologous cell therapies is highly complex and requires cooperation between all members of the value chain, from healthcare providers to couriers and manufacturers. TrakCel’s cloud-based software addresses the need for robust supply chain management, efficient utilization of resources, regulatory compliance, and the control required to safely manage cell therapies through clinical trials to commercial approval.
Unique Supply Chain Challenges for Autologous Cell Therapies
Autologous therapies are especially challenging with respect to supply chain management. These patient-specific therapies begin with the collection of biologic samples from the patient, typically in a clinical/hospital setting. These raw materials must then be transported to the manufacturing center, which may in many cases be geographically distant. Appropriate cells are isolated, and in some cases genetically or otherwise modified, grown to sufficient quantities, and then returned as a finished therapeutic product for infusion into the same patient.
The need to obtain patient-specific starting materials and then return the product manufactured using those raw materials back to the same patient sets autologous cell therapies apart from off-the-shelf (allogeneic) cell therapies and conventional biologic drugs. Establishing a chain of identity for the cells from the outset is essential to ensure that the right products are delivered to the right patients.
Cell therapies are challenging to maintain throughout production and transportation. For autologous therapies, severe time constraints are common, with raw material samples collected from patients requiring delivery to the manufacturing site within 24–48 hours. Scheduling of sample collection must be coordinated with the manufacturing center to ensure production assets (e.g., cleanroom space, technicians) will be available when the starting material arrives.
Both the raw materials and cell therapy products will have specific storage conditions with at best reduced cell viability a consequence of loss of temperature control. Many are transported and stored in liquid nitrogen, which requires special handling. These cell therapies can also be damaged if they are not thawed correctly.
Improvements in Cultural Understanding
The additional supply chain challenges presented by autologous cell therapies are worth facing, because many of these drugs are truly curative therapies for illnesses where other therapeutic options are no longer providing effective clinical responses. Though autologous cell therapy is a relatively new field, significant advances in equipment and distribution have already manifested. However, there is always a risk that when these vital therapies arrive at the hospital, the people who receive them will not know how to properly handle them. A greater cultural understanding will help alleviate these concerns.
The need to obtain patient-specific starting materials and the return the product manufactured using those raw materials back to the same patient sets autologous cell therapies apart from off-the-shelf (allogeneic) cell therapies and conventional biologic drugs.
TrakCel is Contributing to the Solution
There is more that can be done to maximize efficiencies within the overall autologous cell therapy supply chain. TrakCel was established in 2012 to provide a comprehensive technology solution for robust supply chain management at an individual therapy level. A joint enterprise between AwenID, a technology company spun out from Swansea University, and Biotec Services International, a specialist provider of ultra-low-temperature–controlled supply chain management services to the biotechnology industry, TrakCel’s vision was to create a client-driven, collection-to-administration supply chain management platform for the orchestration and efficient management of cell and gene therapies at clinical trial and commercial scale.
TrakCel’s cloud-based cell therapy orchestration software addresses the need for robust supply chain management, efficient utilization of resources, and regulatory compliance without increasing workload or complexity for end-users by delivering the visibility and control required to safely manage cell, gene, and immunotherapies from clinical trials to commercial-stage drug delivery. The fully configurable software delivers personalized processes and workflows for every participant in the supply chain, allowing cell and gene therapy innovators to safely manage and change scale with confidence.
Full chain of identity tracking is maintained from collection to administration, ensuring that the right patient receives the right treatment. Visibility and transparency are achieved with real-time reporting (and alerting if necessary) of each therapy’s progress through the supply chain. Chain of custody tracking and control allows any potential issues to be rapidly identified and resolved. The software is integrated with established third-party service providers (couriers) and their systems, providing visibility and control across the entire supply chain.
Supply chains can be streamlined with TrakCel’s software through the efficient coordination of sample collection, logistics, manufacturing, and treatment administration within a single platform. Rules and constraints are applied to configure schedules for each product and supply chain, with manufacturing capacity and throughput maximized by tracking and managing each step of the workflow.
The TrakCel system can be operated as a standalone platform or through integration with a customer’s internal IT infrastructure. The user-friendly interface is device agnostic and provides access to the intelligent scheduling functionality and pre-populated courier booking system. In addition, workflow-driven functionality ensures compliance with product-specific processes. Global supply chains are also supported with multilanguage capabilities.
Supply chains can be streamlined with TrakCel's platform through the efficient coordination of sample collection, logistics, manufacturing, and treatment administration within a single platform.
Supporting the Entire Cell Therapy Supply Chain
The goal of TrakCel’s platform — to span the entire supply chain — means that a wide range of users interface with the system. The platform is primarily used by therapy owners and clinical trial sponsors to track products from collection to administration, manage clinical trials, and assess vendor performance and resource utilization across the supply chain, as well as to provide audit-ready records that demonstrate compliance.
Other users include physicians and nurses who are supporting patients throughout a treatment. They establish the initial recording for the chain of identity and also use the scheduling functionality to determine the best dates for starting material donation by the patient. Manufacturers (internal sites of the therapy owner or third-party contract service providers) also manage their schedules in the TrakCel platform by tracking inbound starting materials, confirming receipt, scheduling courier pickup of the final product, and notifying the clinic that a shipment is on the way.
Quality assurance personnel find the platform useful for reviewing supply chain information and confirming chain of identity and chain of custody for each patient/product combination. They are also able to review product data recorded through the supply chain (e.g., temperature excursions) and make decisions concerning product integrity. Courier companies, meanwhile, push and pull data to and from the system as they manage material pickups and product deliveries.
Operations personnel have visibility into current enrollment and the status of each patient’s therapy and can manage protocols and products, coordinate activities based on real-time alerts, and even assess compliance at different clinics with product-handling and data-capture requirements.
A Full-Service Software Platform
While the initial plan was to be a software company only, TrakCel has become a full-service company. We recognize that the cell and gene therapy industry is still developing and that many companies are transitioning from paper-based to digital supply chain management for the first time. Since our founding, we have supported a number of advanced therapy companies in North America and Europe, helping our customers confirm and manage both chain of identity and chain of custody for their cell therapies, scheduling and sample collections, and product delivery. Each new customer benefits from the experience we have gained supporting supply chains for many different types of cell therapies through a more effective management solution.
Our project teams work with all stakeholders in the supply chain to develop solutions that meet regulatory requirements and industry best practices while providing the best possible user experiences for each customer. We take a risk-based approach and will suggest additional alerts/alarms for high-risk processes to make sure customers can overcome any challenge. Specific support services include supply chain process mapping, process and workflow design, determination of reporting needs, project management, and user experience design.
We also offer some out-of-the-box integrations with complementary service providers, as well as bespoke development services for the integration of any system across a customer’s supply chain. Most notably, the integration of courier systems dramatically simplifies the supply chain and removes an element of risk.
Our quality team helps to ensure that each TrakCel system is compliant. As a pharmaceutical software vendor, we can provide very detailed assistance regarding the validation of each TrakCel system. TrakCel’s expert IT team, meanwhile, designs and delivers a fully compliant hosted solution using Amazon Web Services (AWS) as the cloud-based platform. The system includes security controls and continuous monitoring to prevent any egregious access (though none has occurred to date).
The entire process — from design to implementation of the final, validated software platform through to our professional services — is overseen by a dedicated project manager who provides guidance on specific requirements for the given TrakCel solution, project scoping and resource assignment, solution planning and deployment, and assurance that the project is delivered on time.
For customers who need additional assistance using their TrakCel platforms, we also offer TrakCel Training Services, including classroom (which took place pre-COVID-19) and remote, in-depth, and interactive courses to ensure that everyone in the supply chain has the knowledge required to effectively use the TrakCel system. We also provide on-call, 24/7 global application support.
Evolving to Meet Changing Industry Needs
As the cell therapy field continues to mature, there are many challenges that must be addressed. One of them is the need for standardization. There has been some movement in this direction, but different data sets are still required from healthcare providers even for very similar products. Systems like TrakCel can help the industry establish a standard approach to data collection for specific types of cell therapies.
Lead autologous cell therapy developers are also building more flexibility into their supply chains by submitting regulatory applications that include the use of both fresh and cryopreserved starting material. This approach allows for two different manufacturing paradigms and reduced pressure on the supply chain, because some of the material can be stored for months rather than 48 hours.
Many cell therapy companies are also expanding their portfolios to spread the risk across a broader pipeline, including therapies for different indications, as well as both autologous and allogeneic products. We anticipate that more personalized CAR-T cell therapies and cancer vaccines will be developed based on patient-specific neoantigen profiles to overcome the challenges presented by solid tumors. The ability to modulate therapeutic responses to avoid side effects and maximize outcomes can also be expected.
Advances are also being made in the time it takes to develop autologous, genetically modified cell therapies. One of the key issues for these treatments is the cost and time involved in viral vector manufacturing. Alternative approaches to inserting genetic material into cells will provide opportunities to drive down both production times and costs.
All of these trends are shaping the way TrakCel is evolving our supply chain orchestration platform. While the supply chain for allogeneic therapies is not quite as complex as that for autologous products, significant tracking is still required, and a robust approach to managing the supply chain is needed for both types of cell therapies. In addition, for both types of products, TrakCel helps reduce costs by increasing the efficiency of supply chain management.