The cell and gene therapy (CGT) sector is undergoing significant change as demand for CAR T cell therapies increases. Since the first approval of a CAR T therapy in 2017, these treatments have shown strong results for patients with limited options. However, current manufacturing methods are not able to keep up with rising demand.
Manual labor currently makes up about half of the cost of producing cell therapies. According to industry leaders, automation is seen as necessary to scale production effectively.
A former executive involved in launching Novartis’ Kymriah and Johnson & Johnson and Legend Biotech’s Carvykti said, “The way we manufacture cell therapies must be fundamentally reimagined.” The executive noted that changes in regulation, technology, and global politics are pushing the field toward automated and standardized domestic production.
Recent U.S. policy changes like the BIOSECURE Act and new FDA data-security rules aim to strengthen domestic CGT manufacturing. The FDA’s Advanced Manufacturing Technologies (AMT) program is also supporting the adoption of automation platforms designed to improve consistency and scalability in production.
Cellares received the first AMT designation in cell therapy for its Cell Shuttle system, which automates end-to-end manufacturing processes. Two other companies—Oribiotech and Cellino—have since received similar designations for their own automated manufacturing technologies. Ori Biotech’s CEO has stated that prioritization by the FDA could reduce development timelines by up to three years (https://www.biospace.com/article/ori-biotech-wins-fda-designation-for-advanced-manufacturing-in-cell-therapy/).
Clinical advances are expanding eligibility for CAR T therapies; some products like Carvykti are being used earlier in treatment plans, while approvals for autoimmune disease indications may soon increase patient numbers further.
As these therapies move from last-line options to earlier-stage treatments, regulators will require manufacturers to meet broader supply standards similar to those applied to other medicines. Automation and digitalization are becoming essential requirements rather than optional upgrades.
Traditional manufacturing methods rely on semi-automated systems that use expensive cleanrooms and manual processes prone to errors. Newer fully automated platforms such as Cell Shuttle use software-driven single-use cartridges, reducing contamination risk and operator involvement while allowing multiple batches at once.
Digital integration between manufacturing operations and quality control (QC) is also gaining attention due to risks associated with fragmented systems and manual documentation. Automating QC processes can lower error rates, speed up data collection, and create ready-to-audit records.
For drug developers, integrated automation provides consistent results across sites, simplifies technology transfer between locations, shortens development timelines, enables earlier regulatory submissions such as INDs (Investigational New Drug applications), lowers clinical supply costs, and accelerates commercialization efforts. Faster product release can also help recruit trial participants more quickly—a key factor when enrollment can take a significant portion of overall development time.
Patients stand to benefit from quicker access to these potentially life-saving treatments as streamlined science reaches more people who need it.
