Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.
The cell and gene therapy (CGT) field has reached a pivotal moment—one many of us saw coming when the first CAR T cell therapy was approved in 2017. The efficacy of these therapies is undeniable, with curative outcomes for patients who have exhausted every other option. Yet the existing manufacturing infrastructure simply wasn’t built to meet the scale of patient demand.
Today, manual labor is estimated to account for 50% of cell therapy manufacturing cost. In my view, streamlined automation is the only path forward to unlocking scale.
Before joining Cellares as Chief Operating Officer, I spent more than two decades bringing life-saving medicines to patients—leading the commercialization and global capacity ramp-up of Novartis’ Kymriah, the first commercially approved cell therapy, and later Johnson & Johnson and Legend Biotech’s Carvykti, which has been called the most successful cell therapy launch to date. Along the way, one truth became clear: the way we manufacture cell therapies must be fundamentally reimagined.
That reimagination is now underway. A wave of regulatory, technological and geopolitical changes has converged to push the field toward automated, standardized and domestically anchored production.
A Changing Landscape and Growing Urgency
Recent U.S. policy shifts, such as the BIOSECURE Act and the FDA’s new data-security rules, underscore an urgent move to strengthen domestic CGT manufacturing. At the same time, the FDA’s Advanced Manufacturing Technologies (AMT) program is accelerating the adoption of automation platforms that improve product consistency and scalability.
We received the very first AMT designation in cell therapy, for Cellares’ Cell Shuttle, a fully closed, end-to-end automated manufacturing system purpose-built to overcome commercialization challenges. Since then, two others have been handed out to Oribiotech and Cellino, also involving cell-based manufacturing techniques.
Meanwhile, clinical success is expanding patient eligibility. CAR T therapies such as Carvykti are now moving earlier in the treatment journey, and approvals in autoimmune diseases are approaching fast, potentially expanding the addressable population by orders of magnitude.
Until now, CAR T therapies have benefited from regulatory flexibility as last-line therapies. As they move earlier, regulators will expect developers to meet the same universal-supply standard applied to other medicines—a tall order under today’s limited capacity. Automation and digitalization are no longer optional; they are prerequisites for sustainable access.
Automated Solutions for an Unscalable System
Legacy cell therapy manufacturing remains constrained by semi-automated systems that depend on expensive cleanrooms and error-prone manual handling that require costly revalidation for even minor process changes. The next generation of fully automated platforms, such as Cell Shuttle, leverage flexible, software-defined manufacturing within single-use cartridges to reduce contamination risk, minimize operator touchpoints and enable parallel batch processing across multiple patient runs.
Equally important is the digital integration of manufacturing with quality control (QC), a hidden bottleneck for cell therapy commercialization that is starting to gain notice. Fragmented analytical instruments and manual documentation risk batch failure and delayed drug product release. Automation of in-process and drug product release testing reduces error, allows real-time data capture and generation of audit-ready batch records.
For drug developers, integrated automation delivers consistent manufacturing across sites, simplifies tech transfer and shortens development timelines. Faster, more reproducible production enables earlier IND submissions, lower clinical supply costs and a more efficient path to commercialization. In competitive indications, where trial enrollment can take up to 30% of total development time, the ability to manufacture and release products faster accelerates recruitment, data generation and approval.
For patients, these gains mean faster access to potentially curative therapies and a future where breakthrough science reaches everyone who needs it.
