Cell therapy has reached a moment where science is no longer the only hurdle to bringing transformative therapeutics to more patients. Even as clinical results continue to bring hope, manufacturing performance and cost structure now play an equally important role in determining whether cell therapy products can become widely accessible to patients.
Clinical promise alone can’t overcome the cost, variability, and fragility built into many current manufacturing models. As demand grows, leaders are asking whether their operational foundations are strong enough to support sustainable commercialization. In this environment, reliability and productivity aren’t just operational metrics—they decide commercial viability.
This article explores why these two pillars matter more than ever, and how strategic modernization of manufacturing processes can reduce risk, improve cost efficiency, and position organizations for scalable growth.
What’s holding back reliable cell therapy production?
Timely delivery of therapy is fundamental to personalized medicine: behind every batch is a patient who may be running out of time. When a run is delayed, fails, or encounters deviations that stall release, the impact is personal, emotional, and immediate.
Despite industry progress, batch failures remain more common than many would expect. The reality is that even small inconsistencies can create disproportionate consequences downstream. Studies show that operator error, equipment failure, contamination, and specification misses collectively represent a majority of failures in commercial manufacturing [1].
These disruptions affect more than the individual patient—they weaken the operational stability needed to grow sustainably and expand patient access. Each failure raises costs, strains trust, and makes long-term viability harder to achieve.
A more reliable future is possible
Organizations are increasingly adopting strategies and technologies that strengthen batch reliability. Many of the most effective improvements are simple shifts to minimize risks throughout workflows. Key approaches include:
- Digitized documentation with electronic SOPs and automated data capture to minimize operator-derived variability, eliminate paper risks, and support GMP compliance.
- Real‑time process monitoring and analytical diagnostics that can verify system readiness before a run begins and alert teams early if issues arise.
- Automatic recovery procedures to avoid total loss—especially important when there’s no chance for a second attempt.
- Closed processes that protect cells from the external environment, lowering contamination risk and creating a more predictable operating environment.
Together, these practices shift teams away from reacting to deviations and toward creating steady, predictable operations that better support patients and long‑term growth.
The operational priorities that matter most for growth
As cell therapy matures, many manufacturing workflows still reflect their research‑stage origins—multiple instruments and disconnected systems stitched together into a patchwork that gets the job done but doesn’t scale easily. These fragmented processes limit throughput, heighten risk of operator error, and leave critical equipment sitting idle.
A closer look at the cost structure of cell therapy production reveals why these inefficiencies matter. Labor and reagents—not consumables or equipment—drive the majority of manufacturing costs, even at small scales of production. This means productivity challenges aren’t rooted in materials; they’re rooted in how work is organized and executed.
The path to commercial viability depends on choosing the right tools and strategies to bring value in terms of reduced labor burden, streamlined workflows, and ease of scaling. By focusing on solutions that simplify execution and support consistent, predictable outcomes, organizations can strengthen cost efficiency and prepare for sustainable growth.
How to take a fresh look at productivity
The organizations gaining the most momentum are those approaching productivity with curiosity—looking closely at where time, attention, and capacity are being lost in day‑to‑day operations. They’re asking:
- How can we reduce idle equipment time?
- Where can automation meaningfully support our teams?
- Which steps are truly bottlenecked, and which can be redesigned for higher throughput?
- How do we build agility into our workflows so we’re ready to respond as demand grows?
In response, many teams are adopting strategies that create efficient operations:
- Breaking apart “all‑in‑one” redundancy to enable parallel use of equipment by separating long, time‑intensive steps from shorter operations.
- Automating high‑touch operations to reduce handling time and free teams to manage multiple workflows at once.
- Digitally connecting previously isolated steps, improving visibility, consistency, and the ability to identify bottlenecks quickly.
- Designing modular manufacturing environments that expand gradually with demand rather than requiring major redesigns.
What’s encouraging is that these changes don’t have to be dramatic. Incremental steps, applied strategically, tend to compound over time to deliver long‑term savings, higher throughput, and reduced scalability risk.
A playbook for building operational strength from day one
Adopting strategies for reliability and productivity early in process development is one of the most effective ways to set up a cell therapy program for long‑term success. Operational decisions made in the earliest stages often determine whether a therapy can scale smoothly or will become constrained by cost, complexity, and variability.
Even a 10% reduction in cost of goods, if applied across all phases of clinical trials, could save up to 10 million dollars over the course of clinical development for a cell therapy product.
Regardless of your current size or stage, progress doesn’t require wholesale reinvention of operations. Many organizations start with a few practical moves to set them up for long-term commercial viability:
Reduce risk and protect continuity
Building a more reliable process requires strategies— such as diagnostic tools and process monitoring—to prevent issues before they happen and enable fast resolution if deviations arise. When paired with guided digitalized workflows and data collection, operator error is reduced and quality assurance teams gain access to accurate, complete records that accelerate review.
Optimize space and infrastructure
By reducing equipment redundancy through parallel workflow strategies, organizations get more from their existing footprint and, in some cases, avoid facility expansions altogether. When processes are closed, some operations may even move into lower‑grade cleanrooms, further easing facility demands and production costs.
Enable and elevate the workforce
Automation isn’t just about efficiency—it’s also about supporting people. When staff are no longer bogged down with complex manual steps or maintaining paper documentation, they’re able to focus on oversight, problem‑solving, and higher‑value responsibilities. This shift builds more engaged teams and a more resilient operation.
Build in scalability
To reliably meet future commercial demand, organizations must ensure that the systems they put in place now can withstand increased volume without introducing new risks. For example, modular systems that allow incremental addition of new capacity can support smoother scale-up and ease investment risk.
When variability decreases and throughput increases, scaling operations no longer feels like a leap of faith—it becomes a natural next step.
Final thoughts on the road ahead for cell therapies
Success in cell therapy now depends as much on operational excellence as on scientific promise. Organizations that focus on reliability and productivity will be best positioned to break through long-standing industry challenges and reach sustainable commercialization.
Your teams already understand where the real opportunities lie—from open processes to labor‑intensive steps that slow delivery and limit scale. By embracing targeted, high‑impact improvements such as digitized documentation, closed systems, real‑time monitoring, and smarter workflow design, organizations can achieve higher batch success and more predictable performance.
Efficient manufacturing is the foundation for the industry’s next stage of maturity. Those who modernize now will set the pace—delivering advanced therapies consistently, affordably, and at the speed patients deserve.
References
- Ranck J. Bioprocessing sees continued improvements in batch failure reductions in 2022. Bioprocess Online. bioprocessonline.com/doc/bioprocessing-sees-continued-improvements-in-batch-failure-reductions-in-0001. Published July 13, 2022. Accessed February 2, 2026.