Radically different
Nature Biotechnology, Published online: 16 July 2026; doi:10.1038/s41587-026-03225-x
Each year, Nature Biotechnology highlights companies that received sizeable early-stage funding in the previous year. Stylus Medicine is engineering novel recombinases for in vivo CAR T cell cancer therapy.
Nature Biotechnology, Published online: 16 July 2026; doi:10.1038/s41587-026-03248-4
J. Craig Venter 1946–2026
Officials at Autolomous and Cellular Origins say the companies have carried out the end-to-end integration of their respective platforms to bring full automation and digitization to the entire cell therapy manufacturing process. This new scalable approach creates a connected manufacturing environment that gives developers greater standardization, traceability, and control across the entire manufacturing process, according to the companies’ spokespersons.
Cellular Origins’ Constellation® automated platform was created to enable cell therapy manufacturing, integrating mobile robotics, existing bioprocessing technologies, and sterile fluid transfer into a coordinated operation. Its flexible, modular architecture allows developers and manufacturers to scale manufacturing capacity as demand grows while maintaining standardized processes, avoiding therapy redevelopment and reducing scale-up risk, notes Edwin Stone, CEO of Cellular Origins.
Autolomous’ digital autoloMATE® platform was designed to allow real-time data exchange and integration across existing software and AI systems, as well as devices and robotic platforms across the entire manufacturing process and supply chain, while safeguarding intellectual property. The modular architecture allows each deployment to be configured to customer needs.
The combined solution overcomes fragmentation, limited visibility, and the absence of standardized, interoperable data flows without replacing existing processes, enabling manufacturers to scale to commercially viable levels, maintains Alexander Seyf, CEO of Autolomous. First integrations have already been achieved at the Cell and Gene Therapy Catapult Digital and Automation Testbeds, as part of an Innovate UK-funded project.
“Scientific ambition has never been the bottleneck in bringing innovative cell therapy to patients, but the delivery infrastructure has brought many challenges,” continues Seyf. “Together with Cellular Origins, we enable fast and efficient scaling from research through to patient administration, ensuring standardization, automation and digitization across the entire process.”
“Scaling cell therapy manufacturing is not just a question of employing automation. It requires a manufacturing system that can evolve with demand,” adds Stone. “Our collaboration with Autolomous, and joint work with the Cell and Gene Therapy Catapult, clearly demonstrates how robotic platforms and digital infrastructure can operate as one.”
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Eli Lilly is acquiring AtaiBeckley, the developer of psychedelic treatments for mental health conditions, to expand its portfolio of neuroscience medicines, the company said Thursday.
The AtaiBeckley deal is just the latest in a string of acquisitions by the pharma giant, flush with cash from its booming GLP-1 business.
Lilly is paying $2.8 billion in cash upfront for AtaiBeckley, with the potential for another $1 billion payout contingent on certain development and regulatory milestones.
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
Later this quarter, Amylyx Pharmaceuticals will read out results from a study evaluating a new treatment for a rare endocrine disorder. It’s a pivotal moment that could support the drug’s approval and comes two years after Amylyx was rocked — and lauded — for voluntarily pulling a drug for ALS off the market because a follow-on study showed it wasn’t helping patients.
The Amylyx drug, avexitide, is being developed to halt severe, uncontrolled drops in blood sugar that some people experience after undergoing stomach-reducing surgery for weight loss.
Axel Johnson Inc. (AJI) has acquired Fort Wayne Metals and the medtech nitinol supplier’s parent company, Fort Wayne Metals Research Products. Terms of the sale were not disclosed. Founded in 1970 by Ardelle Glaze and most recently led and owned by his son Scott Glaze, Fort Wayne Metals will remain headquartered in Fort Wayne, Indiana.…
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Align Technology disclosed a big pay decrease for its CEO and a sizable compensation increase for its median employee in 2025, according to a recent filing. The dental device developer was the world’s 32nd-largest medical device company on the latest Medical Design & Outsourcing Medtech Big 100 ranking by revenue. That ranking was based on…
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Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.
This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”
“Ketogenic diets have distinct effects on different tissues even within the gastrointestinal tract. I think the message here is that we need to be very careful in generalizing the effects that these diets can have, because what might be beneficial for one tissue may be detrimental for another tissue,” says Omer Yilmaz, PhD, director of the MIT Stem Cell Initiative, an associate professor of biology at MIT, and a member of MIT’s Koch Institute for Integrative Cancer Research.
A 2022 study in Nature suggested that ketogenic diets have a protective effect against colon cancer and that BHB—the most abundant ketone body—is responsible for this effect. In the new study, the MIT team wanted to explore whether ketogenic diets might have a similar protective effect in the small intestine.
The researchers fed mice who were genetically predisposed to developing intestinal cancer either a ketogenic diet, a control diet, or a high fat/high calorie diet. They found that mice on a ketogenic diet were more likely to develop tumors of the small intestine than those on a control diet. While they did not become obese, mice on the ketogenic diet developed tumors at rates similar to or even higher than those of mice on an obesogenic high fat/high calorie diet.
Additional studies revealed that ketone bodies did not play a role in tumor development. Instead, tumor growth was driven by fatty acid oxidation. This pathway activates the PPAR family of proteins, which signal stem cells to multiply more rapidly, increasing the chance that some become cancerous.
Surprisingly, the same ketogenic diet that promoted tumors in the small intestine had the opposite effect in the colon. The researchers found, similar to the earlier study back in 2022, that a ketogenic diet suppressed the development of colon tumors. However, the new findings suggest that ketone bodies are not responsible for this protective effect.
“Given how much attention has been paid to ketone bodies like BHB, both as a commercial health trend and in recent high-profile studies suggesting BHB suppresses colon cancer, we fully expected them to be the direct drivers. Instead, our experiments in genetically engineered mice revealed that these molecules are essentially metabolic bystanders. The real surprise is that tumor acceleration is driven entirely by how stem cells process and burn the heavy influx of dietary fat itself,” Yilmaz says.
The researchers now hope to further study why ketogenic diets have such different effects in the colon and the small intestine. As ketogenic diets continue to gain popularity, understanding these tissue-specific effects will be critical for guiding their use, the researchers say.
The findings carry practical implications. Because the diet’s effects—both the tumor acceleration in the small intestine and the protection in the colon—are driven entirely by fat metabolism rather than the ketones themselves, commercial ketone supplements or drinks would not be expected to mimic either the risks or the benefits discovered in this study. This may be especially relevant given that small intestinal tumors have been rising in incidence in recent decades, with the greatest impact on patients with inherited conditions that predispose them to intestinal cancer, such as familial adenomatous polyposis.
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Researchers are increasingly turning to modular mechanistic models to unlock greater efficiency and robustness in mRNA manufacturing, offering a more flexible way to optimize in vitro transcription (IVT) while reducing costly experimental work. According to Wei Xie, PhD, associate professor of mechanical and industrial engineering at Northeastern University, and her colleagues, modular approaches can increase productivity and product quality.
“A modular modeling approach simplifies the complex IVT reaction network by dividing it into discrete, reusable, mechanistically defined steps,” Xie said. “This structure improves mechanistic understanding by clarifying how each step impacts key quality attributes, including yield, capping efficiency, and transcript integrity.”
Rather than relying on a single monolithic model, the framework separates IVT into individual components, such as initiation, elongation, and termination, as well as parallel processes including mRNA degradation and precipitation. Each module can be independently calibrated, validated, and refined as new experimental data become available, allowing researchers to continuously improve predictive performance without rebuilding the entire model.
The modular architecture also lends itself to the evolving nature of mRNA therapeutics. Because the framework mirrors the modular structure of nucleic-acid sequences, it can be rapidly adapted for new constructs, accelerating process development for emerging vaccines and therapeutic candidates while minimizing redevelopment effort. Beyond improving process understanding, the model provides a powerful diagnostic platform for identifying production bottlenecks that constrain yield, productivity, or product quality.
The framework combines Shapley value-based sensitivity analysis, residual analysis, and simulated reaction trajectories to pinpoint limiting process variables. Sensitivity analysis identifies parameters with the greatest influence on performance, while comparisons between predicted and experimental results reveal missing mechanisms or model deficiencies. Simulated reaction profiles can also highlight issues such as nucleotide depletion or suboptimal magnesium-to-nucleotide ratios before they become significant manufacturing challenges.
“Together, these tools provide a data-driven, mechanistic approach to quickly diagnose constraints and guide targeted process optimization,” Xie explains.
The approach also offers significant advantages during scale-up, one of the most challenging phases of bioprocess development. Because the model is grounded in fundamental molecular reactions and biochemical mechanisms rather than empirical correlations, it maintains predictive capability across different manufacturing scales and can be readily applied to new mRNA sequences, all without extensive redevelopment.
Xie says the framework supports predictive design of scale-dependent control strategies, including dynamic pH regulation and fed-batch nucleotide feeding schemes, helping manufacturers reduce development timelines while improving process robustness during technology transfer.
“A key advantage of the modular architecture is its flexibility and interoperability” Xie says. “New enzymes, reagents, or process steps can be incorporated by simply updating or adding the relevant module, without recalibrating the entire model. The framework’s ability to accommodate heterogeneous datasets generated under varying process conditions further supports rapid evaluation of manufacturing innovations while maintaining model consistency.
Perhaps the greatest impact of Xie’s approach lies in advancing quality-by-design (QbD). Acting as an in silico development platform, the modular model enables researchers to evaluate process variables before entering the laboratory. Coupled with digital twin-based Bayesian optimization, the platform narrows the experimental search space, reducing trial-and-error studies while conserving expensive reagents, such as T7 RNA polymerase.
As mRNA pipelines continue to expand beyond vaccines into broader therapeutic applications, modular mechanistic modeling is emerging as a valuable digital bioprocessing tool, enabling manufacturers to accelerate development, strengthen process understanding, and deliver more consistent product quality with fewer experimental resources.
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The static, mounted monitoring systems currently used inside fermentation vats are poised to be replaced in the near future with a network of free-floating bioelectronic sensors, if the vision of researchers from Boston University and Capra Biosciences reaches fruition.
Designed for both vat and continuous bioprocessing systems, this bioelectronic sensor network could, ideally “provide spatial information about where they are in a heterogeneous bioreactor platform…as well as multiple measurements of things such as temperature, pH, dissolved oxygen, and dissolved carbon dioxide,” Rabia Yazicigil, PhD, associate professor, Boston University (BU), and lead principal investigator for this project, tells GEN.
Consequently, the network will report data that enable biomanufacturers to determine whether the solution is mixing properly and to identify transit times throughout the process, in addition to specific processing parameters.
“The key innovation…is that these systems integrate living cells into the electronics,” Miguel Jimenez, PhD, assistant professor, BU, emphasizes. The inclusion of microbes—bacteria or yeast cells, for example—“supercharges the sensors,” enabling them to monitor more parameters that are directly relevant to biomanufacturing.
Roughly the size of a chickpea, these sensors never leave the bioreactor. “That allows us to get measurements throughout the reactor… which helps us build a really rich data set that we can then feed into models to help us monitor and predict performance,” notes Mark Poole, PhD, senior director of manufacturing and applied AI, Capra Biosciences.
“Having lots of high-quality measurements at different points in the reactor is game-changing for any biomanufacturing company,” Poole says.
Jon Valdez, program manager at BioMADE, which funded the project as part of a $21.4 million investment in 14 projects to advance the bioindustrial manufacturing industry, agrees, calling it potentially paradigm-shifting. Potential applications extend to clinical monitoring—where a prior collaboration focused on human gut monitoring. The technology is solvent-agnostic but may be most effective in a water-based environment, enabling applications that may include soil and water quality monitoring. Benefits, he says, include lower costs per sensor (estimated at $10−$100) and decreased risk of contamination.
The project is two-tiered. The first tier, the electronics-only sensor, is the nearest to commercialization. Industrial-scale testing will be conducted soon at Capra facilities. “That [alone] would signify a big advance,” Jimenez says, citing the ability to field networked sensors capable of measuring multiple conditions throughout a bioreactor or continuous production process.
The second tier adds the bio component to those sensors. This feature is in academic development. Primary challenges are how to design biohybrid sensors that can be autoclaved or cleaned-in-place, and strategies to stabilize and encapsulate the microbes to be compatible with industrial requirements. The researchers are considering possible approaches now.
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