How Automation Puts Patients First in Cell Therapy
During a recent roundtable, Adva Biotechnology CEO, Ohad Karnielli and other industry leaders from around the globe gathered for what became an incredibly candid examination of automation's true value proposition in cell therapy production. The conversation quickly moved beyond typical buzzwords, directly addressing the core question: when does automation actually deliver tangible ROI versus theoretical efficiency?
Where Automation Creates Real Value
The most compelling automation cases center on strategic commercial alignment. As one leader eloquently put it, "How do you align automation efforts directly with what actually moves the needle commercially? It's not just about throughput; it's about patient access and market adoption." This perspective reframes automation from a manufacturing efficiency play to a patient access enabler.
When implemented with this commercial lens, automation delivers measurable strengths: reducing critical path bottlenecks that delay patient treatment, enabling consistent quality that supports regulatory confidence, and creating scalable capacity that matches commercial demand curves. "More controls and data will allow us to make tactical changes later on. It's clear, this could really bridge that gap to scaling down the road," shared another participant.
The Hidden Costs of Poor Implementation
However, the discussion revealed uncomfortable truths about automation's pitfalls. "What really is lacking in the way that we look at automation” one leader emphasized. “The fundamental weakness isn't the technology itself, it's implementing automation before understanding what we're actually trying to automate.”
The characterization bottleneck emerged as a critical vulnerability. "I think the short answer will be characterization, process characterization, making sure we have enough data of the right data," noted a participant. "Sometimes we measure a lot of data, but what is the right data?" Without this foundation, automation amplifies uncertainty rather than reducing it, destroying rather than creating ROI.
The cost of poor implementation is very real. But in the volatile landscape of cell and gene therapy, where every batch is a patient's hope and every delay can be devastating, the cost of inflexible automation is catastrophic. The consensus wasn't just a need for automation, but a profound yearning for systems agile enough to evolve with the science, enabling real-time process development, precise control, and continuous optimization during the critical development stage—not as a post-development afterthought. Because in this race against time and disease, rigidity isn't just inefficient; it's a barrier to breakthroughs.
The Strategic Inflection Point
The shift in investor mindset presents automation's greatest opportunity. "I think now we're seeing more and more investors and management saying we have to be correct, we have to be in the right pricing. We have to be able to scale," observed one roundtable member. This evolution from "first to market" to "correct and scalable" creates space for intelligent automation investments.
The concept of "adaptive controls for cells" emerged as a game-changer. Rather than automating fixed processes, we're building systems that intelligently respond to human cell variability. This shifts thinking from rigid automation to flexible, intelligent systems that can deliver consistent outcomes despite biological variability, a true competitive advantage.
Where Automation Destroys Value
Technology fragmentation is more than a mere inconvenience; it's a profound drain on ROI. A striking pattern is emerging: despite adopting automation, sites frequently find themselves wrestling with disparate technologies for each product. This operational complexity isn't just inefficient; it actively undermines the very benefits automation is meant to deliver. As one participant underscored, "We need to be getting to a place where we are using one platform, not three different technologies." The true cost of this sprawl extends far beyond capital expenditure, impacting focus, training, and ultimately, the pace of innovation
The human integration challenge represents perhaps the biggest overlooked threat. As one participant captured it: "The biggest barrier isn't the tech itself, but integrating it seamlessly with our human talent and existing workflows. Automation should augment, not alienate, our teams." When automation displaces rather than empowers human expertise, it creates resistance that undermines ROI.
Speed-to-market in cell and gene therapy creates a fundamental tension in automation strategy. One CAR-T leader emphasized, the imperative to be "first to market" often means manual steps become strategically superior. When patient outcomes are paramount and competitive advantage hinges on speed, premature automation can delay market entry, introducing operational complexity without commercial upside. This "first to market" philosophy recognizes that even perfect automation, if implemented too late, has no patient impact. However, as the industry matures, so does the technology; new efficiencies are becoming available, shifting this critical balance.
The participants circulated on five ROI-focused priorities:
Implement comprehensive process analytics before scaling - Measure the right data that correlates with commercial outcomes
Develop platform strategies to avoid technology fragmentation - Consolidation creates operational leverage
Plan for adaptive manufacturing that accommodates patient variability - Intelligent flexibility drives consistent commercial outcomes
Implement in phases - Modular approaches minimize risk
Design human-machine interfaces that augment talent - Empowerment, not replacement, drives sustainable ROI
The inflection point is no longer about choosing between manual and automated processes. It's about strategically leveraging next-generation, flexible technologies to implement smart automation early. The goal is to maximize patient impact and commercial value by ensuring efficiency and quality from the outset, rather than falling into the trap of past "first to market" strategies that, while quick, often resulted in commercially unviable processes. The most sophisticated strategy now lies in recognizing that integrating controlled, adaptable automation delivers enduring value, ensuring that life-saving therapies are not only available swiftly but also sustainably.
