Machine Learning and Single-Cell Technology Combined to Drive High-Performance Cell Line Development

OneCyte, which focuses on high-throughput single-cell analysis and cell line development technologies, and Kemp Proteins, which specializes in protein engineering and expression solutions, signed a strategic partnership agreement to deliver cell line development services for biopharmaceutical companies.

The collaboration brings together OneCyte’s proprietary single-cell platform for high-throughput and high-speed clone selection with Kemp Proteins’ molecular engineering capabilities, including its machine learning–driven platform, PROTiQ™.

Biopharma companies continue to face significant challenges in cell line development, including long development cycles, suboptimal yields, and high failure rates, particularly for novel and complex molecules, according to Konstantinos Tsioris, PhD, co-founder and president of OneCyte. These challenges can delay regulatory timelines and slow the progression of therapies into the clinic.

The OneCyte-Kemp partnership addresses these pain points by integrating predictive in silico design with rapid and high throughput experimental validation, say officials at both companies. As part of the workflow, amino acid sequences are evaluated using Kemp’s PROTiQ platform to assess developability risks, identify sequence liabilities, and generate structural insights.

The optimized candidates are then paired with OneCyte’s high-performance cell line development platform, which reportedly enables identification of elite clones with higher productivity.

Unlike traditional, rigid development workflows, this integrated approach is designed to adapt quickly to the evolving needs of new therapeutic modalities, notes Tsioris.

“By combining our single-cell technology with Kemp’s deep expertise in protein expression, we are confident that we can address the hardest challenges associated with new modalities, delivering faster timelines and industry-leading titers,” he continues.

“OneCyte’s class-leading single-cell technology, stacked on top of our molecular design and expression capabilities, will provide a powerful and differentiated solution for our global biopharma customers,” says Michael Keefe, CEO of Kemp Proteins.

The post Machine Learning and Single-Cell Technology Combined to Drive High-Performance Cell Line Development appeared first on GEN – Genetic Engineering and Biotechnology News.

STAT+: Pharmalittle: We’re reading about an FDA delay forcing a biotech to close, a Neurocrine deal, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on cups of stimulation. Our choice today is laced with traces of cocoa. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the U.S. Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late, STAT explains. The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

Americans starting weight loss medicines for the first time want lower cost and greater convenience as they consider pills from Novo Nordisk and Eli Lilly, Reuters says, citing seven doctors who specialize in obesity. Novo’s Wegovy pill ​has been on the market since January, while Lilly’s newly approved Foundayo joins the fray this week. Interviews with the specialists show a promising landscape for oral weight loss drugs as ‌the companies compete for share in the fast-changing obesity treatment market that is seen topping $100 billion a year in the next decade. All seven doctors said they had begun prescribing oral Wegovy, and three said they have prescribed the pill to ⁠about 10% of their patients. Of those patients, most are taking a GLP-1 for the first time, rather than switching from injectables, and have not yet reached the highest dose. 

Continue to STAT+ to read the full story…

STAT+: Stealth biotech Stipple bets on secretive ADCs

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A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!

The need-to-know this morning

  • Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday.

A four-month FDA delay derailed a small biotech. Is it a sign of the times?

FDA delays can happen. For large drugmakers, they can be frustrating; for small drugmakers, they can be existential.

Continue to STAT+ to read the full story…

Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer

Extracting cytoplasmic material such as proteins, RNA, and mitochondria often relies on cell lysis using detergents or enzymes, which destroy the cells. Ultrasound and other sophisticated physical disruption methods need to be carefully tuned to avoid damaging biomolecules, potentially rendering them too time-consuming.

Delivering material into cells presents further challenges. Lipid-based carriers are limited to small molecules, viral vectors are costly, and microinjection techniques are difficult to scale. To date, no approach allows for controlled and efficient cytoplasmic transfer without compromising cell viability, according to researchers from Waseda University in Japan.

The team published a study “A Nanotube Injector for Cytoplasmic Transfer and Enhanced Mitochondrial Function” in Small Science that reports the development of a nanotube membrane-based injector—a platform that combines nanomaterials and fluid physics to directly transfer cytoplasmic contents between cell populations. The system consists of a thin gold membrane with vertically aligned nanotubes mounted on a glass tube. When this membrane is carefully pressed against cultured cells, the nanotubes penetrate the phospholipid bilayer of the living cells without causing significant damage. By adjusting the internal air pressure of the glass tube, the researchers can “suck up” cytoplasmic material from the source cells, hold it as the tube is repositioned over the target cell culture, and gently flush it into this new population using microliters of a buffer solution.

Infographic from Waseda University in Japan
Credit: Waseda University

Through several experiments using fluorescent dyes and protein assays, the researchers say they confirmed that cytoplasmic contents could be extracted in a pressure-dependent manner. They also found that careful selection of nanotube diameter, nanotube density, and applied pressure was key to minimizing cellular damage. Notably, under optimized conditions, cell viability hovered around 95%, with a cytoplasmic transfer efficiency of well over 90%, note the scientists.

To further test the capabilities of their platform, the team investigated whether it could transfer intact mitochondria. To this end, they labeled mitochondria in donor cells with a fluorescent tag and observed them in the recipient cells via confocal microscopy. They found that dozens of mitochondria could be reliably delivered per cell.

Most importantly, according to Takeo Miyake, PhD, team leader, these mitochondria remained functional, as evidenced by markedly higher levels of adenosine triphosphate (ATP) produced in recipient cells compared to controls.

“This technology establishes a new paradigm for cell manipulation—transforming cells not by genetic modification but by reconstructing intracellular composition itself,” explains Miyake, adding that such controlled cytoplasmic engineering, enabled by the proposed nanotube injector, could support the development of next-generation cell therapies, improved disease models, and more precise drug screening platforms.

“Directly transferring healthy mitochondria or cytoplasmic components into target cells is particularly relevant for regenerative medicine, where therapeutic cells often suffer from reduced metabolic activity or functional heterogeneity after isolation and expansion,” highlights Miyake, “By restoring or augmenting mitochondrial function without genetic modification, the technology offers a new strategy to improve cell quality prior to transplantation.”

Overall, this innovative system paves the way for a new level of control in cell biology research, as well as bioengineering and biomedical applications, points out the research team.

The post Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer appeared first on GEN – Genetic Engineering and Biotechnology News.

STAT+: How a four-month FDA delay forced a small biotech company to close its doors

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late.

The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

It laid off most of its staff of about 60 people. Then, it auctioned off its lab equipment and sold much of its office furniture, except for the table and chairs in one conference room it kept in case the company got its meeting with FDA staff.

Last week — after the meeting and the breakthrough happened — the company said it would be sold. Kezar hopes the buyer, Aurinia Pharmaceuticals, will take the drug forward, though how quickly that can happen, if at all, is not guaranteed.

It’s also not clear why Kezar’s initial meeting was canceled. But to CEO Chris Kirk, the chain of events fits a pattern over the past year in which volatility at the FDA — including staff departures and decision-making seen as inconsistent — has ricocheted across the industry, impacting drugmakers. Those impacts can fall disproportionately on small companies, which, unlike major drugmakers, often operate on one financing to the next. 

“In my career, I’ve often not agreed with what the FDA has said, but I’ve at least relied on their consistency,” said Kirk, who’s worked in biotech for more than two decades. “That doesn’t appear to be what’s happening now. It feels more stochastic and maybe even capricious, what’s going on at the FDA. And this isn’t good for patients. It’s definitely not good for the biotech ecosystem as a whole.”

Continue to STAT+ to read the full story…

Injectable Microgel Developed to Reduce Bleeding in Infants Undergoing Surgery

Biomedical researchers headed by a team at the Lampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill/North Carolina State University, have developed an injectable microgel to help reduce bleeding in infants who require surgical care. Tests in an animal model showed that the hemostatic microgels, known as B-knob-triggered microgels (BK-TriGs), reduced bleeding by at least 50%.

Research lead Ashley Brown, PhD, who is the Lampe Distinguished Professor of Biomedical Engineering, is co-corresponding author of the team’s published paper in Science Advances, titled “Hemostatic B-knob-triggered microgels (BK-TriGs) to address bleeding in neonates.” In their paper the team concluded “This study highlights the potential of BK-TriGs, designed for neonatal-specific clotting mechanisms, to address the heightened bleeding and thrombosis risks in neonates, who face 4.4 times higher postsurgery mortality … Our findings support BK-TriGs as a promising approach for improving hemostasis in neonates, offering a tailored, effective solution for this vulnerable patient population.”

When adults cut themselves, a multi-step process called hemostasis stops the bleeding from the injured blood vessel. But hemostasis in infants is different from hemostasis in adults. This difference can be problematic if infants require surgery to address significant medical problems. In surgeries, neonatal patients normally receive blood from adult donors to compensate for blood lost during the operation. “Current treatments rely on transfusing adult blood products, which may cause complications resulting from structural and functional differences between neonatal and adult fibrinogen,” the authors wrote. “… these transfusions pose serious safety concerns by increasing morbidity, prolonging intensive care unit stays, and elevating posttransfusion thrombosis risks in neonates.”

Brown noted, “… if you give adult blood to an infant, the difference in adult hemostasis versus infant hemostasis can lead to too much clotting. That can increase the likelihood of thrombosis, where blood clots form in the lungs or elsewhere and put the baby at risk … “My research team has done a lot of work on surgery-related bleeding in newborns, and we wanted to develop a therapeutic intervention that would reduce bleeding and—by extension—reduce the need for infants to receive adult blood transfusions during surgery.”

The scientists have now reported on their development of a material called B-knob triggered microgels (BK-TriGs). “Fibrin is the main clotting protein in human blood,” Brown explains. “There is a short amino acid sequence called a ‘B peptide’ that links together fibrin molecules to create blood clots where they are needed—and these B peptides play a particularly important role in hemostasis for infants. The BK-TriGs are engineered particles that are studded with those B peptides.”

The particles can absorb water and become squishy hydrogels, which mimic the mechanical properties of natural platelets in a way that maximizes the ability of the B peptides to create fibrin networks and stanch bleeding. “Functionalized with a fibrin hole b–specific peptide, BK-TriGs enhance clot density and resistance to degradation,” the team noted.

The researchers first tested the BK-TriGs by using microfluidic devices that allowed them to conduct in vitro testing to see how the microgels affected clotting in blood plasma from human adults and infants. “In vitro studies using neonatal platelet-poor plasma (PPP) showed that at an optimal concentration, BK-TriGs increased clot density by more than 100% and improved stability by reducing fibrinolysis,” they wrote in summary. “Under flow conditions BK-TriGs promoted robust clot formation compared to plasma-only controls.” Brown noted, “We found that BK-TriGs worked better at improving blood clotting in infant plasma than in adult plasma, which was what we expected to see.”

To further test the efficacy of the BK-TriGs, the researchers worked with lab mice that were genetically engineered to not make fibrinogen, the precursor to fibrin. This allowed the researchers to first introduce infant fibrinogen into the lab mice so that the mice exhibit a form of hemostasis similar to infants. “This innovative model enabled the evaluation of BK-TriGs in a setting that replicates key aspects of neonatal fibrinogen polymerization and fibrinolytic sensitivity, providing preliminary insights into their potential clinical utility.”

Brown added, “We found that the BK-TriGs outperformed any of the other options we tested at reducing blood loss. Specifically, the BK-TriGs reduced blood loss by 50-60% compared to the control group.”

The authors further stated, “The findings highlight the potential of BK-TriGs as a promising synthetic platelet-mimetic approach for enhancing clot density and stability, particularly in neonatal plasma where traditional blood products may pose risks … A fibrin-targeted approach like BK-TriGs, which enhances clot formation without introducing systemic thrombotic risk, may offer a safer alternative to adult fibrinogen transfusions.”

Next steps for the work are to see how BK-TriGs compare to other hemostatic therapeutics that are on the market, either on their own or when used in conjunction with BK-TriGs. “The results we’re reporting here are exciting, but we are still far removed from clinical use,” Brown, acknowledged. “We need to make sure there are no unforeseen risks associated with blood clotting.” The team also commented, “Expanding this research to include different clinical bleeding scenarios will be essential to advancing these materials toward therapeutic applications.”

“This is particularly relevant in neonates, where the most severe bleeding complications often arise in critical sites such as the gastrointestinal tract and the brain,” Brown continued, “But if we do find BK-TriGs are safe and effective, we’re optimistic this could be a cost-effective way to make surgery safer for infants. Manufacturing the BK-TriG particles would be relatively inexpensive—certainly in comparison to blood products.”

The post Injectable Microgel Developed to Reduce Bleeding in Infants Undergoing Surgery appeared first on GEN – Genetic Engineering and Biotechnology News.

Four things we’d need to put data centers in space

MIT Technology Review Explains: Let our writers untangle the complex, messy world of technology to help you understand what’s coming next. You can read more from the series here.

In January, Elon Musk’s SpaceX filed an application with the US Federal Communications Commission to launch up to one million data centers into Earth’s orbit. The goal? To fully unleash the potential of AI without triggering an environmental crisis on Earth. But could it work?

SpaceX is the latest in a string of high-tech companies extolling the potential of orbital computing infrastructure. Last year, Amazon founder Jeff Bezos said that the tech industry will move toward large-scale computing in space. Google has plans to loft data-crunching satellites, aiming to launch a test constellation of 80 as early as next year. And last November Starcloud, a startup based in Washington State, launched a satellite fitted with a high-performance Nvidia H100 GPU, marking the first orbital test of an advanced AI chip. The company envisions orbiting data centers as large as those on Earth by 2030.

Proponents believe that putting data centers in space makes sense. The current AI boom is straining energy grids and adding to the demand for water, which is needed to cool the computers. Communities in the vicinity of large-scale data centers worry about increasing prices for those resources as a result of the growing demand, among other issues.

In space, advocates say, the water and energy problems would be solved. In constantly illuminated sun-synchronous orbits, space-borne data centers would have uninterrupted access to solar power. At the same time, the excess heat they produce would be easily expelled into the cold vacuum of space. And with the cost of space launches decreasing, and mega-rockets such as SpaceX’s Starship promising to push prices even lower, there could be a point at which moving the world’s data centers into space makes sound business sense. Detractors, on the other hand, tell a different story and point to a variety of technological hurdles, though some say it’s possible they may be surmountable in the not-so-distant future. Here are four of the must-haves we’d need to make space-based data centers a reality. 

A way to carry away heat 

AI data centers produce a lot of heat. Space might seem like a great place to dispel that heat without using up massive amounts of water. But it’s not so simple. To get the power needed to run 24-7, a space-based data center would have to be in a constantly illuminated orbit, circling the planet from pole to pole, and never hide in Earth’s shadow. And in that orbit, the temperature of the equipment would never drop below 80 °C, which is way too hot for electronics to operate safely in the long term. 

Getting the heat out of such a system is surprisingly challenging. “Thermal management and cooling in space is generally a huge problem,” says Lilly Eichinger, CEO of the Austrian space tech startup Satellives.

On Earth, heat dissipates mostly through the natural process of convection, which relies on the movement of gases and liquids like air and water. In the vacuum of space, heat has to be removed through the far less efficient process of radiation. Safely removing the heat produced by the computers, as well as what’s absorbed from the sun, requires large radiative surfaces. The bulkier the satellite, the harder it is to send all the heat inside it out into space.

But Yves Durand, former director of technology at the European aerospace giant Thales Alenia Space, says that technology already exists to tackle the problem.

The company previously developed a system for large telecommunications satellites that can pipe refrigerant fluid through a network of tubing using a mechanical pump, ultimately transferring heat from within a spacecraft to radiators on the exterior. Durand led a 2024 feasibility study on space-based data centers, which found that although challenges exist, it should be possible for Europe to put gigawatt-scale data centers (on par with the largest Earthbound facilities) into orbit before 2050. These would be considerably larger than those envisioned by SpaceX, featuring solar arrays hundreds of meters in size—larger than the International Space Station.

Computer chips that can withstand a radiation onslaught

The space around Earth is constantly battered by cosmic particles and lashed by solar radiation. On Earth’s surface, humans and their electronic devices are protected from this corrosive soup of charged particles by the planet’s atmosphere and magnetosphere. But the farther away from Earth you venture, the weaker that protection becomes. Studies show that aircraft crews have a higher risk of developing cancer because of their frequent exposure to high radiation at cruising altitude, where the atmosphere is thin and less protective.

Electronics in space are at risk of three types of problems caused by high radiation levels, says Ken Mai, a principal systems scientist in electrical and computer engineering at Carnegie Mellon University. Phenomena known as single-event upsets can cause bit flips and corrupt stored data when charged particles hit chips and memory devices. Over time, electronics in space accumulate damage from ionizing radiation that degrades their performance. And sometimes a charged particle can strike the component in a way that physically displaces atoms on the chip, creating permanent damage, Mai explains.

Traditionally, computers launched to space had to undergo years of testing and were specifically designed to withstand the intense radiation present in Earth’s orbit. These space-hardened electronics are much more expensive, though, and their performance is also years behind the state-of-the-art devices for Earth-based computing. Launching conventional chips is a gamble. But Durand says cutting-edge computer chips use technologies that are by default more resistant to radiation than past systems. And in mid-March, Nvidia touted hardware, including a new GPU, that is “bringing AI compute to orbital data centers.” 

Nvidia’s head of edge AI marketing, Chen Su, told MIT Technology Review, that “Nvidia systems are inherently commercial off the shelf, with radiation resilience achieved at the system level rather than through radiation‑hardened silicon alone.” He added that satellite makers increase the chips’ resiliency with the help of shielding, advanced software for error detection, and architectures that combine the consumer-grade devices with bespoke, hardened technologies.

Still, Mai says that the data-crunching chips are only one issue. The data centers would also need memory and storage devices, both of which are vulnerable to damage by excessive radiation. And operators would need the ability to swap things out or adapt when issues arise. The feasibility and affordability of using robots or astronaut missions for maintenance is a major question mark hanging over the idea of large-scale orbiting data centers.

“You not only need to throw up a data center to space that meets your current needs; you need redundancy, extra parts, and reconfigurability, so when stuff breaks, you can just change your configuration and continue working,” says Mai. “It’s a very challenging problem because on one hand you have free energy and power in space, but there are a lot of disadvantages. It’s quite possible that those problems will outweigh the advantages that you get from putting a data center into space.”

In addition to the need for regular maintenance, there’s also the potential for catastrophic loss. During periods of intense space weather, satellites can be flooded with enough radiation to kill all their electronics. The sun has just passed the most active phase of its 11-year cycle with relatively little impact on satellites. Still, experts warn that since the space age began, the planet has not experienced the worst the sun is capable of. Many doubt whether the low-cost new space systems that dominate Earth’s orbits today are prepared for that.

A plan to dodge space debris

Both large-scale orbiting data centers such as those envisioned by Thales Alenia Space and the mega-constellations of smaller satellites as proposed by SpaceX give a headache to space sustainability experts. The space around Earth is already quite crowded with satellites. Starlink satellites alone perform hundreds of thousands of collision avoidance maneuvers every year to dodge debris and other spacecraft. The more stuff in space, the higher the likelihood of a devastating collision that would clutter the orbit with thousands of dangerous fragments.

Large structures with hundreds of square meters of solar arrays would quickly suffer damage from small pieces of space debris and meteorites, which would over time degrade the performance of their solar panels and create more debris in orbit. Operating one million satellites in low Earth orbit, the region of space at the altitude of up to 2,000 kilometers, might be impossible to do safely unless all satellites in that area are part of the same network so they can communicate effectively to maneuver around each other, Greg Vialle, the founder of the orbital recycling startup Lunexus Space, told MIT Technology Review.

“You can fit roughly four to five thousand satellites in one orbital shell,” Vialle says. “If you count all the shells in low Earth orbit, you get to a number of around 240,000 satellites maximum.”

And spacecraft must be able to pass each other at a safe distance to avoid collisions, he says. 

“You also need to be able to get stuff up to higher orbits and back down to de-orbit,” he adds. “So you need to have gaps of at least 10 kilometers between the satellites to do that safely. Mega-constellations like Starlink can be packed more tightly because the satellites communicate with each other. But you can’t have one million satellites around Earth unless it’s a monopoly.”

On top of that, Starlink would likely want to regularly upgrade its orbiting data centers with more modern technology. Replacing a million satellites perhaps every five years would mean even more orbital traffic—and it could increase the rate of debris reentry into Earth’s atmosphere from around three or four pieces of junk a day to about one every three minutes, according to a group of astronomers who filed objections against SpaceX’s FCC application. Some scientists are concerned that reentering debris could damage the ozone layer and alter Earth’s thermal balance. 

Economical launch and assembly

The longer hardware survives in orbit, the better the return on investment. But for orbital data centers to make economic sense, companies will have to find a relatively cheap way to get that hardware in orbit. SpaceX is betting on its upcoming Starship mega-rocket, which will be able to carry up to six times as much payload as the current workhorse, Falcon 9. The Thales Alenia Space study concluded that if Europe were to build its own orbital data centers, it would have to develop a similarly potent launcher. 

But launch is only part of the equation. A large-scale orbital data center won’t fit in a rocket—even a mega-rocket. It will need to be assembled in orbit. And that will likely require advanced robotic systems that do not exist yet. Various companies have conducted Earth-based tests with precursors of such systems, but they are still far from real-world use.

Durand says that in the short term, smaller-scale data centers are likely to establish themselves as an integral part of the orbital infrastructure, by processing images from Earth-observing satellites directly in space without having to send them to Earth. That would be a huge help for companies selling insights from space, as many of these data sets are extremely large, and competition for opportunities to downlink them to Earth for processing via ground stations is growing.

“The good thing with orbital data centers is that you can start with small servers and gradually increase and build up larger data centers,” says Durand. “You can use modularity. You can learn little by little and gradually develop industrial capacity in space. We have all the technology, and the demand for space-based data processing infrastructure is huge, so it makes sense to think about it.”

Smaller facilities probably won’t do much to offset the strain that terrestrial data centers are placing on the planet’s water and electricity, though. That vision of the future might take decades to come to fruition, some critics think—if it even gets off the ground at all. 

STAT+: Biotech investors’ plea to Trump, and a busy M&A week

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The Trump administration is using newly announced 100% tariffs as leverage to push both large and small drugmakers into confidential pricing and manufacturing agreements.

Also, the burgeoning peptide craze is highlighting a trust gap in medicine, in which patients increasingly favor unproven treatments over well-established drugs.

Continue to STAT+ to read the full story…