What's Stopping You Automating Your Cell Therapy Processes Right Now?
I was recently hooked on a Malcolm Gladwell podcast. The guest, Diogo Rau, CDIO at Eli Lilly (an ex-Apple guy, interestingly, with no science background), dropped a truth bomb. He was floored, when in his first strategy meeting, they were discussing a set of forecast numbers. Not for that quarter, not even for that financial year. Nope. Lilly was forecasting for 2036. 2036!
In CGT, we like to think we're playing the long game, right? Access, adoption, the whole shebang. As our recent roundtable revealed, that 'long game' can get easily sidetracked. We gathered six of the sharpest minds in CGT – the CTOs and technical ops folks in the trenches, on the daily grind of manufacturing miracles. The topic? 'What's stopping you from automating your cell therapy processes right now?'
We dove headfirst into the nitty-gritty. Here’s their insight into what’s holding back automation, and more importantly, how we can start kicking those roadblocks to the curb.
The Big Picture: Navigating the CGT Adoption Landscape
It turns out, the barriers to automation aren't just about the nuts and bolts of robotics and software. There's a broader strategic inertia at play. One participant hit the nail on the head, stating,
"Sometimes it feels like we're so focused on getting the first batch out the door, we forget to build the factory for the future."
This sentiment echoed throughout the conversation. The urgency of reaching those initial clinical milestones, while understandable, can inadvertently sideline crucial investments in scalable and automated processes.
Another leader pointed out the inherent complexity: "Every therapy feels like a bespoke creation. Standardisation for automation feels like trying to herd cats – highly skilled, but with their own agenda." This highlights the challenge of moving from highly manual, artisanal processes to robust, automated systems that can handle the inherent variability of cell-based therapies. The fear of losing that "artisanal touch," while perhaps romantic, is a significant hurdle to embracing the efficiency that automation promises.
Interestingly, the conversation also touched upon the crucial link between automation and the ultimate mission: patient access.
"If we truly want to democratize cell therapy and make it accessible to more patients, automation isn't a luxury – it's a necessity."
This reframes the discussion, moving beyond short-term gains to the long-term vision of a scalable and sustainable CGT ecosystem.
Characterisation and Control: The Automation Imperative
The discussion then pivoted to the practicalities of implementing automation, particularly around characterisation, process monitoring, and control. The consensus was clear: relying on manual, often subjective methods simply won't cut it as the field matures. As one technical leader put it bluntly, "We can't keep relying on someone's expert eye and a micropipette as our primary QC strategy. That's not a process, that's an act of faith!"
The group explored the potential of integrating advanced analytical tools and process monitoring technologies directly into automated workflows. This not only promises to enhance data quality and consistency but also to provide a deeper understanding of the critical process parameters that impact product quality. One participant shared enthusiastically, "Imagine a closed, automated system where every critical parameter is continuously monitored and fed back into the process in real-time. That's not science fiction; that's the future we need to build."
However, the conversation also acknowledged the challenges of integrating these sophisticated tools. As another CTO cautioned, "The data deluge can be overwhelming. We need smart systems that can not only collect vast amounts of data but also intelligently analyse it and provide actionable insights." The key here isn't just about collecting data, but about turning that data into knowledge that drives process optimisation and ensures product consistency.
Aligning for Access: Beyond Short-Term Wins
Ultimately, the roundtable underscored the importance of aligning automation strategies with the overarching mission of expanding patient access to these life-changing therapies. It's about looking beyond the immediate pressures of clinical trials and building a foundation for sustainable and scalable manufacturing. As one participant eloquently stated,
"We need to shift our mindset from 'getting to the clinic' to 'getting to everyone who needs it.' And automation is the engine that will drive that journey."
The insights from this virtual think tank were clear: the CGT field stands at a critical juncture.
We need clinical success but it can come at a cost. Neglecting the strategic imperative of automation risks creating bottlenecks down the line, hindering our ability to deliver on the adoption promise of cell therapy. The path forward requires a conscious and concerted effort to integrate automation not as an afterthought, but as a fundamental pillar of CGT development.
Let's keep this dialogue going! What are your thoughts on the automation imperative in CGT?
