As outlined in our previous post, cell and gene therapies (CGTs) inherently involve complex, individualized processes. In some therapies, that can mean small scale production (for instance in typical allogeneic treatments), while others can be fully end-to-end individualized (such as CAR-T and other autologous treatments). Either way, such therapies differ significantly from standard pharmaceuticals in that they must be managed patient by patient, often with tight, hourly schedules. This complexity is neither a flaw nor merely a challenge but the foundational reality of advanced therapies, and one that create problems when it comes to scaling to commercial production.
At LogiPharma 2025, industry leaders emphasized that effectively scaling these therapies hinges on integrated planning. This means synchronizing detailed, site-level operations with broader network strategies to ensure agility, clarity, and proactive management. In line with this trend, our own Frederik Jaenen co-presented a masterclass at the event, with Allen Jacques of OMP. Together, they demonstrated the critical value that integrated planning offers to advanced therapy medical product (ATMP) developers and manufacturers striving to manage patient-centric processes.
We continue the exploration of this topic below.
Traditional planning often operates in isolated silos. Network planners focus on forecasting demand, allocating resources, and managing site capacity at a high level. Meanwhile, site-level planners grapple with the immediate constraints of technician schedules, equipment availability, and cleanroom management. These groups typically use separate tools and data sets, creating significant gaps in communication and coordination.
Such disjointed planning inevitably leads to bottlenecks and operational inefficiencies. In large scale biopharma production, much of this is absorbed by the sheer efficiencies of scale involved in mass manufacture, but smaller scale gene therapies – and definitely single-patient-batch cell therapies – simply don’t have that benefit. Worse still, network plans that don’t account for site-level practicalities force local teams into reactive adjustments. In CGT supply chains, where precise timing directly impacts patient treatment, these disruptions can escalate from operational headaches into critical clinical risks.
Addressing these challenges doesn’t require a single overarching planning process, rather it needs a harmonious integration of planning processes at all levels. Site planners require detailed visibility on resource availability, equipment scheduling, and quality assurance processes. Conversely, network planners need a comprehensive view to forecast capacity accurately, identify resource gaps, and manage multi-site coordination effectively.
Such an approach transforms operational complexity into predictable, manageable workflows. By integrating these distinct but interdependent planning layers, organizations can proactively address challenges before they escalate.
Consider a practical example discussed at LogiPharma 2025 and showcasing an integration between Bluecrux’s Binocs™ and OMP’s Unison Planning™ systems:
With integrated planning, every stakeholder – from executives to site operators – shares a real-time, unified operational view, facilitating informed decision-making and rapid responsiveness.
Why not join our upcoming Cutting X webinar “Breaking silos: the power of integrated SC-QC planning”! We will deep-dive into a real-world use case that leverages the unique integration between Binocs and Unison Planning to deliver tangible benefits to one of the world’s leading biopharma companies.
Integrated planning enables companies to effectively manage and respond to supply chain and operations disruptions:
The goal isn’t absolute perfection but operational resilience, informed responsiveness, and planning agility. In CGT supply chains, agility means being able to confidently manage inherent complexity, swiftly make informed decisions, and maintain operational momentum.
The challenge for planners, then, is to reduce (or entirely remove) those blockers that inhibit agility: cleanroom contamination? Batch failure? Rescheduling work to accommodate the unexpected shouldn’t take hours, it should be possible at the click of a button. Anything more complex is simply getting in the way of positive patient outcomes.
As CGTs transition from limited clinical applications to broader commercial use, operational complexity and regulatory demands increase substantially. Scaling advanced therapies means that treatments previously reserved for select patient groups will reach broader populations, significantly amplifying logistical complexity.
Rising regulatory standards demand greater transparency, consistency, and control, while broader geopolitical and sustainability considerations increase pressure to comprehensively optimize supply chains while maintaining robustness. It’s a tricky tightrope to walk, with organizations needing to achieve seamless coordination and complete visibility across their entire operations if they wish to scale effectively.
When planning is disconnected, operational disruptions become increasingly frequent (e.g. missed production slots, underutilized resources, emergency logistical adjustments). Such disruptions are symptomatic of deeper systemic misalignments, where site teams face unrealistic schedules, network planners underestimate operational constraints, and clinical teams encounter treatment delays.
Repeated misalignments damage trust, elevate risks, and reduce operational efficiency. Effective resolution requires integrated, collaborative planning, ensuring all stakeholders operate from a unified understanding of operational realities.
As the CGT market continues to expand, operational complexity will intensify further. Strategic integration between site-level scheduling and broader network management ensures supply chains remain synchronized, adaptive, and robust. With integrated planning, schedules are executable, responses are rapid, and clinical-commercial alignment remains consistently strong.
Ultimately, integrated planning isn’t just operational excellence, it’s essential for delivering transformative therapies to patients reliably and efficiently.
Ready to harness complexity as a strategic advantage? Contact us today to explore how integrated planning can transform your CGT operations.
And don’t forget to join our 26 June 2025 webinar on this topic if you want to see a live demo!
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