With an increasingly promising roster of approved cell therapies still burdened by complex manufacturing, multiple companies have emerged in recent years on a mission to simplify production for the class of advanced therapeutics.
Led by the likes of Cellares and Ori Biotech, technology developers have pushed forward automated closed systems, often dovetailing with other tech like robotics and artificial intelligence, to help reduce manual touchpoints across the cell therapy manufacturing chain. Ultimately, the companies’ goal is to crank out cell therapies more consistently at scale, and often at the promise of lower cost, too.
With industry and venture capital interest in automated cell therapy production beginning to build from about 2016 onward, some 23 companies working in the field have now raised a collective $1.1 billion across 34 rounds through April 24, data intelligence platform Tracxn wrote in a new report.
The bulk of that capital (81%) is held by Cellares and Ori Biotech, which have raised $612 million and $281 million respectively, according to the firm’s analysis. The “central finding” of the report, according to Tracxn, is “capital concentration,” with the remaining $205 million of tracked funds split between 21 other automation firms.
The report looked at a total of 23 companies spread across 11 countries, though Cellares and Ori have certainly been the most prominent faces of the industry’s automated cell therapy manufacturing push. That notoriety has been amplified by regulatory wins and notable Big Pharma tie-ups for the two companies in recent years, as well, with both Ori and Cellares’ platforms now the only ones in the automation game to hold the FDA’s coveted Advanced Manufacturing Technology (AMT) designation.
Cellares’ approach, dubbed the Cell Shuttle, is an end-to-end manufacturing system, about the size of a truck, that combines all the technologies needed to complete a cell therapy production run in a single piece of kit.
For its part, Ori has advanced its IRO platform, a similar approach that the company has described as a fully closed system that strives to automate, digitize and standardize the most labor-intensive steps of cell and gene therapy manufacturing.
The need for cell therapy production improvements is acute, which in turn lends support to approaches like Cellares’ and Ori’s, Tracxn argued in its report.
While approved cell therapies like CAR-Ts, natural killer (NK) cells and stem cell-derived products have emerged as potent treatment options across a swathe of indications, they “are also, by any industrial standard, the most expensive and fragile to manufacture,” Tracxn noted, pointing to the manual, operator-intensive processes that must be performed in highly sterile environments where patients’ cells are handled at “virtually every step.”
The report further flagged an up to 18% batch failure rate tracked across conventional manufacturing methods for the class of personalized medicines. Meanwhile, a large quantity of cell therapies in the industry pipeline could eventually strain existing manufacturing capacity “if even a fraction of these trials reach approval,” Tracxn cautioned.
Cell therapy factory platforms, meanwhile, offer improvements through a mix of closed systems, which reduce direct operator contact and contamination risk.
As part of its analysis, Tracxn further looked at the geographic spread of cell therapy automation efforts.
At present, the U.S. and the United Kingdom host the bulk of these efforts, with 13 of 23 companies spread across the two.
Rather unsurprisingly, China represents the next-biggest geography for the approach by disclosed equity, followed by Europe, where companies have footprints in France, Switzerland and the Netherlands, per Tracxn.
Tracxn broke its company coverage down across three broad categories: fully integrated end-to-end manufacturing systems like those used by Ori and Cellares; robotic automation clusters that operate existing instruments, such as the approaches utilized by Multiply Labs and Cellular Origins; and automated single unit-operation hardware that tackles specific steps in the production chain.
The data intelligence outfit also assessed a fourth category around software and AI optimization, which it said it included as “an enabling layer that makes the hardware smarter.”
As for where cell therapy automation is headed, Tracxn noted that the AMT designations secured by Cellares and Ori represent a “meaningful signal of regulatory support” for the approach. As it stands, only Cellares and Ori have both commercial-scale capacity on tap and the key AMT designation, which allows developers using tagged platforms to engage quicker with the FDA and establish a clearer pathway with the agency for production parameters.
Still, as the field comes into its own, several key challenges remain for cell therapy automation, Tracxn caveated.
If an approved product is already made manually, switching to an automated platform could come with steep comparability requirements. In addition, end-to-end platforms also require substantial upfront investment, both from the platform developers and their clients, which limits adoption to “well-capitalized therapy developers and CDMOs,” per Tracxn.
Moreover, getting manufacturing sign-off for a novel platform takes time, and for early-stage companies—even those with “technically compelling platforms”—the gap may not be “easily compressed,” the report states.