Digital Infrastructure for Cell and Gene Therapies
The Shift to Standardisation and Scale
Akshay Peer, Chief Product Officer, TrakCel
Antonios Spanos, Industry Advisor, TrakCel
CGTs can offer curative potential for previously untreatable diseases due to their personalised, patient-specific nature. However, these advantages also demand strict management of their supply chain. This article explores the growing challenges created by the current fragmented digital landscape for CGTs and makes the case for a transition toward standardisation and scale.
Cell and gene therapies (CGTs) can offer curative potential for previously untreatable diseases due to their personalised, patient-specific nature. However, these advantages also demand strict management of their supply chain. This chain is fundamentally complex, spanning everything from starting material collection and specialised manufacturing to stringent temperature-controlled logistics and ultimately, timely delivery of the therapy back to the patient.
In this article, Dr Akshay Peer (Chief Product Officer) and Antonios Spanos (Industry Lead) at TrakCel explore the growing challenges created by the current fragmented digital landscape for CGTs and make the case for transitioning toward standardisation and scale. This shift is crucial to help unlock the full potential of these therapies, reduce the burden on clinical teams, and ensuring scalable access for patients globally.
The challenge of standardising orchestration in CGTs
The complexity of orchestrating the CGT supply chain is significantly increased compared with traditional pharmaceutical logistics. Due to the personalised nature of these therapies, the intricate orchestration process involves multiple stakeholders and stringent, often non-negotiable, temperature and timing requirements. To ensure timely and successful delivery of CGT products, all stages must be diligently coordinated with careful management of the Chain of Custody (COC) and Chain of Identity (COI).
For early CGT pioneers, coordinating these steps often relied on inadequate, manual processes and disparate systems, which immediately introduced systemic risks. Reliance on disparate systems can lead to transcription errors, a lack of standardisation, fragmented data, communication gaps, and no real-time visibility, all inevitably hindering efficiency. In addition, already busy Authorised Treatment Centre (ATC) staff are forced to navigate fragmented processes, contributing to inefficiency and a cumbersome customer experience.
Faced with these challenges, the developers of currently approved CGTs, like CAR-T products, have attempted to overcome them by leveraging bespoke software solutions to support their specific products and pipelines. While an understandable effort to gain control, this customised approach established a precedent that would ultimately lead to a larger, industry-wide issue, which has proven to be expensive, time-consuming, and most critically, a significant impediment to standardisation across the industry.
The resulting proliferation of disparate portals is now creating systemic inefficiencies, particularly at the treatment center level and across community care settings, manifesting as a pervasive issue known as “portal fatigue.”
How bespoke portals create inefficiencies at the treatment center level and community care settings
The core problem with portal fatigue lies in the structural differences across platforms, such as variations in nomenclature, process steps, definitions, and data formats. The issues with bespoke, proprietary solutions are multifaceted and include:
1. Financial and time burden of bespoke development
Developing custom digital solutions often takes longer and costs more than expected, straining budgets and delaying key milestones. Updating bespoke systems to meet new regulations or clinical standards demands costly redevelopment and IT support, diverting funds from innovation and patient care. As technology evolves, these tailored platforms risk obsolescence, requiring continual investment to stay functional and compliant.
2. User experience failures and impact on patient safety
Custom-built platforms often overlook the daily needs of healthcare staff, resulting in inconsistent interfaces and inefficient workflows that cause confusion and frustration. Without user-centered design or feedback integration, these systems can increase the risk of miscommunication and clinical errors, ultimately compromising patient safety and quality of care.
3. Fragmentation and systemic integration challenges
When systems lack standardisation, sharing data across platforms becomes difficult, hindering collaboration and slowing decision-making. Healthcare providers waste time navigating multiple systems instead of focusing on patients, while organisations struggle to adapt to new technologies or regulations, limiting innovation and progress across the CGT sector.
4. Costly integration of bespoke solutions with the broader CGT network
CGT products require a network of stakeholders to work together to deliver for each patient, including:
• Hospitals
• Community clinics
• Payers
• Distributors
• Courier providers
• Manufacturing facilities
• Operations
• Supply chain functions
• CDMOs
• QA/QC labs
Maintaining and updating these ever-growing network integrations presents a substantial, ongoing challenge.
5. Lack of specialised features
Custom-built platforms often lack the agility and specialised capabilities needed to keep pace with the fast-evolving CGT sector. Even when built on commercial systems, their slow adaptation to new technologies and processes limits innovation and responsiveness. This lack of flexibility ultimately constrains manufacturers’ ability to evolve, hindering progress across the entire industry.
The FDA anticipates an influx of novel CGT products, which will exacerbate the challenges posed by custom-built solutions, making it increasingly difficult for healthcare providers to cope and threatening to bottleneck patient access. To address this looming crisis, the industry must transition towards standardised practices across CGT orchestration platforms.
Standardisation is the key to unlocking multi-site delivery and scale
The complexity of the CGT supply chain can be addressed with a decisive shift toward standardised, widely adopted practices. This is particularly crucial in settings where therapies are delivered across multiple, geographically disparate sites such as hospital sites, specialised collection centers and decentralised clinics.
Standardised orchestration platforms serve as the central hub necessary for coordinating every stakeholder, securely tracking the COC and COI, managing complex logistics, and ensuring global regulatory compliance. By moving to standardised platforms:
• Interoperability is guaranteed: Standardisation enables seamless, secure data exchange between manufacturers, treatment centers, labs, logistics partners and Electronic Health Records (EHRs). This eliminates the reliance on costly, custom point-to-point integrations and creates true, real-time visibility across the end-to-end supply chain.
• Workflow risk is reduced: A consistent digital experience across multiple therapies and sites minimises the cognitive burden on ATC staff, drastically reducing the training time and the potential for clinical error rooted in navigating unfamiliar systems.
• Scalability is achieved: A standardised foundation allows manufacturers to onboard new clinical sites, distributors, depots and CDMOs rapidly and efficiently, turning a previous integration hurdle into a repeatable deployment process.
• Global and community expansion is supported: As CGT manufacturing expands into new regions beyond traditional U.S. hubs, standardised orchestration platforms become essential for maintaining interoperability across diverse geographies. Standardisation ensures that regional facilities, suppliers and treatment centers can seamlessly integrate with global networks, enabling consistent processes, reliable data exchange and unified compliance standards regardless of location.
Technology providers play a vital and active role in driving this industry-wide shift. Their mandate is to develop standardised platforms that not only adhere to established industry standards but also actively promote interoperability by design. These commercial platforms must be designed as agnostic tools, serving as the central, intelligent hub for secure and efficient communication across all stakeholders.
This requires deep commitment to industry collaboration. Open communication and knowledge sharing among different stakeholders, including manufacturers, technology vendors, and healthcare professionals, are essential to fostering the development and rapid adoption of unified practices. Technology providers can champion standardisation by actively participating in industry initiatives, adhering to established guidelines, and building platforms with open Application Programming Interfaces, the foundational tools for enabling seamless, “plug-and-play” data sharing with existing enterprise systems. By working together, stakeholders can create a unified digital ecosystem that facilitates seamless data exchange, reducing ambiguity and ultimately accelerating the delivery of life-saving therapies.
Key considerations for selecting the right orchestration platforms
Given the inherent complexity of CGT orchestration, selecting a technology platform is a crucial, strategic decision. Various factors must be considered to ensure the platform aligns with the vendor's needs, while maintaining standardised good practice and fostering collaboration:
• User-centric design and ease of use for ATCs: Look for platforms with intuitive interfaces and workflows that are streamlined but robust enough for CGT specifics. This approach directly combats portal fatigue by minimising the training required for ATC staff and ensuring consistent processes across different therapies. Ultimately, a focus on user experience is a focus on patient throughput and clinical time preservation. For end users, this means less time navigating multiple systems and more time focusing on what matters most: delivering safe, efficient care to patients.
• Adaptability and future-proofing: The CGT landscape is constantly evolving, with new therapies, technologies, and regulations emerging regularly. Choosing an adaptable platform that can readily accommodate these changes is vital for long-term success. Configurability, modular design, and a commitment to ongoing development from the technology provider are key factors to consider. For clinicians and coordinators, this adaptability ensures the systems they rely on remain relevant and responsive, reducing disruption and keeping workflows familiar even as therapies advance.
• Robust integration capabilities: Digital fragmentation introduces risk, whereas seamless data flow reduces it. A high-quality orchestration platform should offer robust, open integration capabilities. This means the system must readily connect with existing core infrastructure. Open Application Programming Interfaces and established partnerships are non-negotiable, as they ensure secure data exchange and eliminate the costly, bespoke, point-to-point integration projects that previously caused issues. Prioritising solutions that already champion industry standards secures interoperability by design. For users, this translates to a smoother, more consistent experience across systems, removing redundant data entry and reducing errors that slow down care delivery.
• Commercial viability and value: The platform should be built for the future scale of the CGT market. Decision-makers should prioritise solutions that address cost-effectiveness and scalability upfront. Look for vendors who offer a clear and transparent pricing model with options that cater to different needs and budgets. Decision-makers must also consider the platform's potential for maximising value, assessing factors like robust data security and a clear product roadmap that outlines future innovation and development. For end users, this means a stable, well-supported system that’s continuously improved without adding new complexity or unexpected costs.
• Choosing the right vendor as a strategic partner: Beyond the technology itself, the commitment of the vendor is a vital factor. Deep industry experience, regulatory knowledge, strong vendor support, ongoing maintenance, timely updates, and responsive support are essential for smooth operation. Furthermore, a vendor who actively participates in industry initiatives and promotes standardisation demonstrates a fundamental commitment to the long-term success of the CGT ecosystem. For those on the front lines, this partnership ensures reliable tools, fewer workflow disruptions and confidence that their platform will evolve alongside industry needs.
Securing the future of CGTs at scale
The digital foundation of CGTs is reaching a critical inflection point. The early-stage necessity of bespoke, proprietary portals has become the primary bottleneck to scaling these potentially life-saving treatments. The inherent inefficiencies they create, from clinical burden and financial overruns to heightened patient safety risks, are becoming more unsustainable as the industry moves toward mass commercialisation.
The transition to standardised, collaborative and purpose-built orchestration platforms is an essential shift required to help achieve genuine scale. By prioritising solutions that champion interoperability, alleviate the burden on clinical teams and offer a truly future-proof design, manufacturers can secure the efficiency, safety and broad patient access necessary to realise the full curative potential of CGTs globally.
Author Bio
Dr Akshay Peer is Chief Product Officer at TrakCel. He has many years of experience in creating technology-based solutions for the cell and gene therapy industry. His long-standing tenure in this field reflects a dedicated commitment to advancing innovation and contributing to the industry's growth.
Antonios Spanos is the Industry Advisor at TrakCel , As a geneticist with over a decade of experience, including six years in pathology laboratories and clinical trial operations, Antonios has a wealth of knowledge in Cell and Gene Therapy supply chains and a proven track record of delivering transformative digital solutions in healthcare and cell & gene therapy.
