As cell and gene therapy developers face rising pressure to produce therapies faster and at lower cost, the industry is leaning on robotics, digital systems and partnerships to bridge the gap between innovation and delivery.
Cell and gene therapy (CGT) manufacturing is nearing an inflection point, especially around scale and access, due to labor, cost and speed-to-market pressures.
To address this, developers and manufacturers are increasingly looking to digitize and automate systems and processes to keep up with current and future market demands. Collaboration across the CGT ecosystem is key to expediting production and supporting broader patient access.
Labor, Cost and Data Challenges
Perhaps the most important challenge facing the CGT sector in 2026 is manufacturing scalability. Current production methods are labor-intensive, time-consuming and pricey, with single batches costing upwards of $500,000 to produce.
There are not enough skilled biologists globally to manufacture these therapies, said Edwin Stone, CEO of Cellular Origins. In addition, the repetitive nature of some production tasks means the average tenure of a staff member is only 18 months. In production, humans are inherently a contaminant within a sterile setting, which means more waste equipment and data and quality checks. Humans also allow for the potential for errors, such as crossing a lab floor and accidentally shaking a bioreactor that causes cell loss or even dropping one.
Thus, robotics and automation can be a solution, Stone said.
With much of the current equipment in manufacturing facilities, data is taken via handwritten notes or collected on a USB stick, said Stuart Lowe, head of Advanced Therapies at TTP. The CGT industry is digitizing legacy items, so they can connect with a manufacturing dashboard, he added.
Digital Systems Advancements
Under the old-school framework, the “chasm of scale is quite insurmountable,” said Jason Jones, head of global business development at Cellular Origins. To better address potential patient opportunities, shifting say, annual product capacity from tens of thousands to three times that, production must be “turbo-boosted” while maintaining the same manufacturing process to ensure regulatory approval.
But changing existing hardware is costly and runs the risk of companies having to redo validation and comparability testing, Lowe said. For many companies, it makes sense to make iterative rather than wholesale tech reconfigurations.
Other companies offer standardization across processes. Cellular Origins has a robotic digital platform that allows for automation for scale and standardization across systems, with robotics allowing for a second-by-second digital journey.
Machine learning in turn can parse out this data for potential safety or mechanical signals or faults, as well as clinical outliers. AI can learn to correct errors in the process and suggest useful updates, said Jones and Miguel Forte, president of the International Society for Cell & Gene Therapy (ISCT).
Scalability is crucial to ensure the CGT industry continues to thrive, said Alexander Seyf, founder and CEO of Autolomous, which provides manufacturers with integrated and digitized supply chain software to track the CGT workflow.
CGT Collaboration Necessary
In this brave new world of digital and automation, it’s crucial that all players in the CGT ecosystem collaborate to ensure the field of therapeutics and manufacturing advances, Seyf and Jones agreed. Both noted increased partnerships across manufacturers, device companies and therapy developers.
Jones noted Cellular Origins is co-developing devices with Fresenius, Cytiva and Thermo Fisher Scientific to integrate them with robots and software. There are also discussions with CRO Charles River Laboratories and CDMO Catalent. In terms of outsourced providers, they are keener to collaborate when there is a mutual client versus having to upgrade on their own volition, Jones added.
Autolomous’ collaborations include sponsors, CDMOs, academics, biologics testing and blood centers, Seyf said.
These partnerships are key as they consider the full patient journey, Seyf said. Jones agreed, adding that doing so allows CGTs to be designed for global patient access.
You can hear more on this week’s Denatured podcast episode.
