The cell and gene therapy (CGT) revolution is finally here. In 2024 alone, roughly 3,000 developers were actively involved in around 2,000 clinical trials worldwide, with investments rising by 30% to over $15 billion. With more than 70 therapies already approved globally, including nine new FDA approvals last year, the momentum is undeniable. Nevertheless, the patient-centric nature of CGT manufacturing has significantly challenged the traditional model of life science supply chains.
As industry leaders highlighted at LogiPharma 2025, the industry’s legacy systems simply weren’t developed to accommodate the highly personalized treatment types seen across autologous cell therapies and in an increasing number of customized allogeneic therapies. Traditional planning methods designed for large batch or production line-oriented manufacturing just cannot handle the nuances of these new clinical requirements. In this post, we will explore why advanced therapy medical product (ATMP) treatments are forcing the life sciences industry to dramatically reassess its longstanding supply chain paradigm.
Unlike traditional pharmaceutical products, which are bulk-manufactured and held as inventory, ATMPs are largely patient-specific or small-batch. Consider CAR-T therapies: a patient’s own cells are harvested, genetically modified, expanded, and returned to that same individual for reinfusion, typically within a 15-20 day window. There’s virtually no buffer inventory – each step must precisely align with individual patient schedules.
Even allogeneic therapies, where cells from a healthy donor are modified to treat multiple patients, require careful personalization in the final stage. Such treatments require more than a simple measured dose and often must be manufactured according to the specific patient’s weight, cryopreserved, and then shipped at a time that is synchronized with their scheduled hospital stay.
In either case, ATMP recipients are typically extremely sick and vulnerable, meaning that delays aren’t just costly – they risk critical therapeutic and viability windows and, ultimately, patient lives.
While traditional pharmaceutical operations are consumer-focused, the reality is that the companies themselves rarely come into contact with the end user after the clinical trial phases wrap up; the terminus of their supply chain is typically the pharmacy or the commercial distributor. In CGT operations, however, the patient isn’t just the supply chain endpoint but actually represents an integral part of the entire workflow, even (in the case of autologous supply chains) being the de facto supplier of critical materials.
The logistical complexity here is profound: clinical schedules, collection center coordination, manufacturing timelines, and quality checks must synchronize seamlessly. Every step, from cell collection to reinfusion, relies on strict chain-of-identity and chain-of-custody protocols, with the patient central to planning. A missed apheresis appointment or delayed courier delivery can quickly escalate. As a result, visibility, traceability, and real-time responsiveness are critical factors for CGT in a way that they simply weren’t for traditional therapies.
Today’s ERP systems and classical supply chain APS tools were primarily designed for high-volume, production-line-oriented manufacturing. They typically focus on fungible products, interchangeable resources, and buffer inventories, all of which differ fundamentally from the operational reality of advanced therapies.
In CGT manufacturing, each patient treatment represents its own unique supply chain, with specific clinical timings, resource requirements, and operational constraints. Without tools explicitly designed for patient-centric planning, organizations find themselves relying heavily on manual adjustments, last-minute rescheduling, and reactive operational management.
Cell and gene therapy manufacturing resembles a specialized laboratory more than a pharmaceutical factory. Facilities juggle autologous batches for individual patients, allogeneic lots for multiple recipients, revalidation runs, and unexpected recovery batches, all simultaneously. Each batch has distinct materials, labor profiles, and time-sensitive requirements.
Scheduling at CGT facilities involves different constraints compared to traditional manufacturing – primarily focused on competences, specialized equipment use, and detailed patient-specific timings. A single disruption, such as a delayed viral vector or equipment failure, can significantly impact scheduling, straining already limited resources. Traditional planning solutions simply aren’t built around these specific, detailed constraints.
Successfully managing CGT complexity requires rethinking how planning is conducted. Rather than starting with generic production schedules, planning must originate from individual patient orders. This patient-focused model maps backward from specific treatment needs, integrating forecasting, scheduling, and operational execution into a single, coordinated system.
As highlighted at LogiPharma 2025, solutions like Bluecrux’s Binocs™ and OMP’s Unison Planning™ exemplify this integrated approach. More than a simple collaboration between technology vendors, these products are available out-of-the-box as a fully-integrated solution that combines and connects manufacturing and quality planning systems. This allows CGT treatment providers to achieve seamless patient integration and address complex constraints (such as specialized competencies, shared cleanroom resources, and strict clinical deadlines) through real-time visibility, predictive scheduling, and dynamic adjustment capabilities.
Even beyond advanced therapies, such an integrated technological approach allows traditional pharmaceutical and biotech companies to adopt a more patient-centric planning paradigm that ultimately contributes to greater value generation across the entire end-to-end supply chain.
By necessity, the transition to integrated planning systems represents a significant opportunity for enhanced operational efficiency. More efficient scheduling of CGT therapies can substantially increase resource utilization and reduce the cost per patient, making therapies for rare diseases more viable and accessible, ultimately benefiting a broader patient population and facilitating the transformation of traditional supply chains into true value chains.
At LogiPharma 2025, the industry’s leading planners recognized the urgency of moving beyond traditional approaches, emphasizing investment in new solutions capable of effectively integrating end-to-end processes, thereby transforming complexity into a competitive advantage.
Want to see how an integrated supply chain can actually work in practice? Stay tuned for our next post, in which we will explore real-world scenarios of integrated planning in action!
Can’t wait? Why not reach out and chat with one of our team for more information today!
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