Researchers’ Spinout Focuses on Simplifying Viral Vector Purification

U.S.-based researchers have developed a portfolio of peptide ligands for purifying viral vectors for gene therapies and have launched a company that develops affinity technologies for biopharmaceutical manufacturers.

ChromaGenix, a spinout from North Carolina State University (NC State), commercializes peptide ligands as an alternative to the traditional protein ligands used in affinity chromatography.

According to Stefano Menegatti, PhD, CSO at ChromaGenix and a professor in the Department of Chemical and Biomolecular Engineering at NC State, the ligands are cheaper and less likely to trigger an immune response in patients than the protein ligands traditionally used.

“Protein ligands have been a fantastic enabler of advanced biological therapies over the past two decades, but they do have shortcomings,” he explains. “Proteins can denature or degrade, potentially releasing immunogenic fragments, which poses a certain level of risk.” As such, Menegatti says, protein ligands have a short lifetime and must be replaced frequently, adding further to production costs. They can also bind too strongly to the product, making it harder to recover it from the chromatographic step.

By contrast, peptide ligands, which are very small proteins, overcome these issues, he says. They can be produced synthetically, making them cheaper than proteins. As they don’t have a complex structure, they can be cleaned under harsh conditions without becoming inactive. They have a longer lifespan and a much lower immunogenicity risk, Menegatti says. Also, as they’re small, he explains,they can be cleared during final product filtration.

This “represents a new frontier of gene therapy manufacturing, says Menegatti, “as it boosts the efficiency of the viral vector manufacturing pipeline.”

Having developed peptide ligands for a wide variety of viral vectors, ChromaGenix is already selling to many companies, Menegatti says. The researchers and the company are now hoping to move beyond gene therapies.

“Our next chapter is going to be developing ligands for the purification of therapeutic cells, starting with CAR [chimeric antigen receptor] T cells,” he says.

The post Researchers’ Spinout Focuses on Simplifying Viral Vector Purification appeared first on GEN – Genetic Engineering and Biotechnology News.

Regulators Should Rely on Peers’ GMP Audits to Cut Inspection Burden

Biopharma is a global industry with drug firms routinely supplying medicines to multiple markets from the same manufacturing plant. But while globalization has helped expand revenues, it has also increased the number of GMP inspections developers undergo.

The average biopharmaceutical production facility has 2.68 good manufacturing practices (GMP) inspections a year, with auditors spending up to nine days on site per visit, according to recent analysis.

Preparing for an inspection typically involves GAP analysis to determine how current practices measure up to regulations, followed by corrective actions.

Companies also need to ensure they have the correct documentation for all operations. How long these preparatory steps take varies for each company. However, according to the U.S. Center for Professional Innovation and Education, getting set up for an audit can take anywhere from six months to a year.

Down with duplication

But drug companies should not have to undergo multiple GMP visits, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which says regulators can cut the number they carry out through collaboration.

Sérgio Cavalheiro Filho, IFPMA’s regulatory affairs manager, tells GEN, “The most pressing compliance challenge relating to good manufacturing practice today is the inefficiency created by duplicative inspections.

“In an increasingly complex and globalized manufacturing landscape, it is critical that we look to reduce unnecessary duplication through greater inspection reliance amongst those national regulatory agencies that belong to the Pharmaceutical Inspection Co-operation Scheme.”

For the uninitiated, the Pharmaceutical Inspection Co-operation Scheme is an informal arrangement between regulators focused on GMP. Its key aims are to harmonize inspections and promote information sharing between regulators.

It also aims to foster trust between regulatory agencies, with the idea being to encourage them to rely on GMP inspections carried out by fellow regulators rather than re-auditing sites themselves each time certification is sought.

“Greater inspection reliance would allow both regulators and companies to focus resources where they matter most: patient safety and product development,” Filho says.

IFPMA made the case for greater inspection reliance in a position paper, arguing that while pilot mutual recognition efforts have shown promise, regulators have yet to fully embrace the approach.

Filho tells GEN, “Regulators have made meaningful progress on GMP harmonization through frameworks such as PIC/S and ICH, but more consistent use of inspection reliance is needed to translate alignment on paper into real efficiency.”

Part of the problem is that advanced modalities, such as mAbs and cell and gene therapies, are often perceived as being higher risk, which means, despite the various mutual recognition agreements, regulators still tend to carry out their own inspections.

However, in such cases, trusting others’ audits is a more efficient option, according to Filho, who says, “Relying on trusted regulatory partners where appropriate is a well‑tested and effective strategy that enables regulators to focus on higher‑risk activities. And, any steps to reduce the incidence of the GMP audits they face would be welcomed by biopharma, Filho adds.

“Industry supports moving from pilots to routine reliance, underpinned by sound legal and data‑sharing frameworks. GMP challenges are also increasingly addressed through collaboration between manufacturers and technology suppliers, and through digitalization, automation, and AI‑enabled tools that strengthen monitoring and quality oversight within robust quality systems,” he says.

The post Regulators Should Rely on Peers’ GMP Audits to Cut Inspection Burden appeared first on GEN – Genetic Engineering and Biotechnology News.

STAT+: Color Health moving deeper into cancer services, complete with virtual ‘tumor boards’

The way Color Health’s CEO Othman Laraki sees it, cancer has a scaling problem. New science regularly sets new standards of care, increasing the intricacy of managing an already complex illness. Cancer patients are multiplying faster than oncologists, Laraki said, and costs, too, are exploding. All this makes it difficult for everyone to receive the best possible therapy. The solution that the Silicon Valley executive sees is inevitable.

“In our mind, the only way this is going to be addressed and solved is in a virtual first, AI-driven manner,” Laraki said. “In the coming years, the biggest cancer centers will be virtual first.”

Virtual care for cancer may sound like an oxymoron. After all, the pillars of cancer treatment are almost all hands-on: surgery, radiation, infusions, and the like. But Color Health has been building out a virtual cancer clinic — including a virtual “tumor board” of multidisciplinary experts —  that the company says can deliver and manage care at a high quality. The company just received a certification from the American Society of Clinical Oncology to back it up.

Continue to STAT+ to read the full story…

Matthew Rabinowitz: Engineering a New Era of Diagnosis

Jonathan D. Grinstein, PhD, North American Editor of Inside Precision Medicine, hosts a new series called Behind the Breakthroughs that features the people shaping the future of medicine. With each episode, Jonathan gives listeners access to his guests’ motivational tales and visions for this emerging, game-changing field.

Matthew Rabinowitz switched from engineering and computational research to medicine after a breakthrough on the Human Genome Project. He realized that telecommunications, aerospace, and machine learning technologies could help him understand human biology. His shift in focus was influenced not only by scientific interest but also by personal loss, including the deaths of family members affected by genetic conditions. These experiences convinced him that current diagnostic methods were inadequate, especially for patients and families in critical situations.

After founding Natera, Rabinowitz and his team developed Panorama Prenatal Test, a noninvasive prenatal test. This technology uses DNA variant analysis, Bayesian statistical methods, and machine learning to detect genetic conditions in cell-free fetal DNA in maternal blood samples. It increased accuracy, accessibility, and reduced invasive procedures. Myome, his new project, uses whole genome sequencing to find rare diseases. Myome uses AI models to assess cancer and cardiovascular disease risks using genomic and clinical data to improve early detection and prevention.

In this episode, Rabinowitz discusses regulatory constraints, fragmented data systems, and difficulties translating complex genetic information into clinical decisions. In the long run, he wants to create blood test diagnostics that can predict health and allow proactive medical intervention.

Rabinowitz uses several technical engineering and computational concepts, including:

  • Packet Switching: a method of dividing data into smaller units that are transmitted independently and reassembled at their destination
  • Transformer Model: a type of artificial intelligence system that processes entire datasets simultaneously to identify relationships between elements, widely used in modern AI systems such as GPT
  • Gradient Descent: an iterative method used in machine learning to minimize error by adjusting model parameters

This interview has been edited for length and clarity.

 

IPM: What originally drew you into applying engineering and machine learning to genetics and clinical diagnostics?

Rabinowitz: There was all this incredible work happening in the early 2000s around the Human Genome Project, along with applications of signal processing and machine learning, which is what I focused on during my electrical engineering training.

There were really three catalysts for me.

One was in 2003, when my sister gave birth to a child with Down syndrome at one of the top hospitals in the country, and they didn’t know until he was born. I spent six days flying around trying to help. They went through one procedure after another and after six days, the baby died from complications. It was absolutely horrific.

Second, I couldn’t believe that we had all these advanced technologies in our phones, laptops, and spacecraft, but they hadn’t made their way into clinical diagnostics. At that point, I felt I had to apply my background in signal processing and early machine learning to these problems.

The third reason was about 15 years ago, I lost a child due to a genetic condition, an absolutely devastating experience. After going through that, I felt there was a path I needed to follow.

The engineer in me took over. It felt like a problem I had to solve. It was like being struck twice: unrelated events, but the same kind of tragedy.

That’s when we used a pregnancy sample to apply for NIH funding to improve prenatal testing. We got that grant, then several others, and ultimately built Panorama, which has transformed pregnancy care globally.

From there, one thing led to another. Now, through Myome and companies like Natera, we’re working on projects that could save the U.S. healthcare system around $200 billion per year. It’s been a very personal mission. 

 

IPM: What are you seeing today with whole genome analysis that feels fundamentally new or different?

Rabinowitz: We’re now diagnosing conditions with whole genome analysis that simply weren’t detectable before. Myome has largely led the charge.

When I look at these case studies today, I get the same feeling I had 20 years ago. How were we not able to see this before?

We’ve spent a lot of time extracting signal from noise so you don’t need multiple sequential tests. You can start with the whole genome and layer analyses. This includes SNPs, CNVs, difficult deletions, tandem repeats, mitochondrial DNA, and methylation.

One example: an eight-year-old with developmental delay, autism, and hypotonia had already undergone exome sequencing with no findings. We identified a subtle deletion about one kilobase involving a single exon too large for short-read breakpoints and too small for coverage changes. That finding completely changed the child’s life.

Another example: a man in his mid-20s with dystonia, convulsions, and vomiting had undergone standard neuromuscular panels. They missed a tandem repeat very difficult to detect with short-read or exome sequencing. We developed new statistical methods and identified the breakpoints, which changed his life.

More broadly, rare disease costs in the U.S. are about $1 trillion annually with ~47 physicians involved over a 4–7 year diagnostic journey and massive lost productivity. The fact that we can now catch these cases is remarkable.

On the pregnancy side the belief was that the issue was solvable, but the technologies were limited. People at the time used shotgun sequencing and looked at DNA quantity. We instead analyzed SNPs between individuals.

We built a massively multiplexed PCR system ~20,000 primers in a single reaction. The challenge is noise, cross reactions, and primer dimers. We developed a machine learning optimization so every primer is tuned relative to every other, standardizing thermodynamics across the system.

From there, we built a statistical framework integrating across trillions of hypotheses, crossover events, noise, and fetal fraction. When it converges, you see a clear maximum likelihood peak that tells you what’s happening. If not, you know something is wrong.

This allowed us to detect things others couldn’t: very high sensitivity for aneuploidy and structural variants like microdeletions.

We could detect triploidy and vanishing twins, determine zygosity, and even de novo mutations, which are more than five times as common as Down syndrome. It was a completely new approach combining passion, engineering, and statistics.

 

IPM: Why can’t we have one universal test that does everything?

Rabinowitz: The short answer is that there’s so much more we can extract from each sample, especially with AI.

These transformer models trained to predict the next word require learning enormous context. With gradient descent, backpropagation, and large datasets, the performance is extraordinary. We didn’t fully appreciate the significance early on but today the possibilities are enormous.

That said, you can’t have one universal test. First, sample context matters. In pregnancy, you’re analyzing fetal cell-free DNA very different from adult disease testing. Second, it’s not just blood. There are many analytes. Beyond DNA, you need methylation, RNA, proteins. Most diseases require a multi-analyte approach. Third, regulation. You need to validate each test rigorously. You can’t validate everything at once across the genome. We also have variants of unknown significance. If you look for everything, interpretation becomes a problem.

So you have to focus your inquiry and ensure results are validated and actionable. That said, from a single blood draw, we can already do an incredible amount.

 

IPM: How has cfDNA and noninvasive testing evolved with AI?

Rabinowitz: Around 2017–2018, Natera began applying deep learning to diagnostics. [It was] one of the first large-scale uses in genetic testing. We had used neural networks earlier (e.g., in HIV mutation analysis) but this was different.

We applied convolutional neural networks to detect microdeletions in low fractions of cell-free DNA. A key example is 22q11.2 deletion syndrome. This occurs in about one in every 1,500 to 2,000 pregnancies. It’s more common than many screened conditions. Early detection allows intervention at birth. We initially used classical statistics, but after generating millions of samples, we trained deep learning models. The AI learned noise patterns and edge cases better than we could model, like Kasparov versus Deep Blue.

In a study of ~20,000 patients, we saw 100% sensitivity for larger deletions and ~83% for smaller ones, with a specificity of 99.95%. That translated to a positive predictive value (PPV) of ~53%, compared to 3–5% clinicians are used to.

Despite this, adoption has been slow due to reimbursement and guidelines, which is frustrating, because many children still miss early diagnosis.

 

IPM: Looking forward, how is AI transforming broader healthcare and genomics?

Rabinowitz: Today, we’re combining whole genome sequencing with AI and clinical data to predict disease risk far more accurately than even five years ago.

Across ~30 major diseases we can now predict susceptibility at a transformative level. If applied broadly, for example to people over 45, we could save over $200 billion annually by catching diseases earlier. Many interventions are simple like diet and lifestyle. Even small improvements matter. Every 1% increase in sensitivity can mean ~$7 billion in savings.

We’re also predicting neoantigens for personalized cancer vaccines, training on real patient outcomes—something that wasn’t possible before. And we’re building foundational genomic models, like language models, that learn the structure of the genome itself.

So across diagnostics, treatment, and prevention, AI is fundamentally transforming the field.

 

IPM: You mentioned earlier that you underestimated neural networks. What changed your perspective?

Rabinowitz: Around 2005, we were applying machine learning to genetics. We weren’t wrong, but we underestimated neural networks. We worked on HIV drug resistance. predicting which mutations respond to which therapies.

We used lasso regression, support vector machines, [and] carefully constrained models. Neural networks didn’t perform as well, which is what we expected. Our mindset was to control complexity to avoid overfitting. What we didn’t anticipate was massive data, stochastic training, and compute power, which allowed neural networks to escape local minima and scale. 

In 2010, I had a patent on training neural networks with memory. It lapsed because Stanford didn’t maintain it. That was right before Google Brain scaled these approaches. The lesson is to stay open-minded. Technology can open possibilities you don’t see coming.

 

IPM: How do you see the future of diagnostics evolving from a single blood draw?

Rabinowitz: We’re moving toward a world where a single blood draw can tell us an enormous amount. Historically, progress was slow: blood cell counting in the 1800s, automation in the mid-1900s, cell-free DNA in the 1990s. Since then, progress has been explosive. From one sample, we can identify incidental findings (e.g., rare diseases, pharmacogenomics, and predictive risk) across many conditions. We can also detect cancer noninvasively through circulating DNA.

The capabilities are remarkable, but the genome is complex—three billion bases, with interactions that require enormous data to model.

 

IPM: What challenges remain in making these technologies widely usable?

Rabinowitz: Two main challenges. First, data, standardizing and aggregating clinical data across institutions, is historically very fragmented. AI is helping, but more coordination is needed.

Second, education. As we generate more information, explaining it to doctors and patients becomes harder. What’s known, what’s uncertain, and what action to take. At Myome and Natera, we invest heavily in genetic counseling. But across the field, there’s a tendency to simplify by withholding information. That won’t scale. We need better ways to communicate complexity responsibly.

 

IPM: How important is diversity and multi-ethnic data in building accurate models?

Rabinowitz: It’s absolutely critical and still underserved. Many models were trained on homogeneous populations, limiting accuracy. We’ve focused on building multi-ethnic models using diverse datasets and functional genomics, but we still need more data from underrepresented populations.

For example, in cardiovascular disease, we built a multi-ethnic model using large datasets.

We were able to reclassify ~50% of patients in the intermediate-risk category, identifying who is truly high risk (>20%) versus low risk (<5%). That improved decision-making significantly with over 10% improvement in classification. When followed over time, outcomes matched predictions closely.

This has huge implications for individuals and for healthcare systems. By identifying risk earlier and intervening, often with simple lifestyle changes, we can reduce costs and improve outcomes at scale. That’s why building diverse, high-quality datasets is so important. It’s one of the most powerful ways to improve healthcare globally.

 

The post Matthew Rabinowitz: Engineering a New Era of Diagnosis appeared first on Inside Precision Medicine.

The Download: seafloor science and military chatbots

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

Inexpensive seafloor-hopping submersibles could stoke deep-sea science—and mining

Last week, two oblong neon submersibles started to descend nearly 6,000 meters into the Pacific Ocean. Throughout the rest of May, they will map the seafloor in search of critical mineral deposits. 

If all goes well, the vehicles, built by Orpheus Ocean, could help scientists probe the vastly understudied deep sea—and the resources it holds—at a fraction of the cost of existing systems.

But the same submersibles are also attracting deep-sea mining companies, raising concerns about environmental impacts. Find out why they’re drawing so much attention.

—Hannah Richter

The new war room: 10 Things That Matter in AI Right Now 

A new kind of system has entered the war room: conversational AI tools that commanders turn to not just for analysis, but for advice. 

One US defense official told MIT Technology Review that personnel might give these advice engines a list of potential targets to help decide which to strike first. China is commissioning similar tools too.

But as the systems gain traction, they’re also sparking concerns about AI-generated errors, a lack of transparency, and Big Tech gaining undue influence over what information gets seen. 

Here’s how these AI advice engines could impact the battlefield.

—James O’Donnell

The new war room is one of the 10 Things That Matter in AI Right Now, our list of the big ideas, trends, and advances in the field that are driving progress today—and will shape what’s possible tomorrow.

MIT Technology Review Narrated: is fake grass a bad idea? The AstroTurf wars are far from over. 

In 2001, Americans installed just over 7 million square meters of synthetic turf. By 2024, that number was 79 million square meters—enough to carpet all of Manhattan and then some. The increase worries folks who study microplastics and environmental pollution.  

While the plastic-making industry insists that synthetic fields are safe if properly installed, lots of researchers think that isn’t so. 

—Douglas Main 

This is our latest story to be turned into an MIT Technology Review Narrated podcast, which we publish each week on Spotify and Apple Podcasts. Just navigate to MIT Technology Review Narrated on either platform, and follow us to get all our new content as it’s released.

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 Elon Musk pushed OpenAI to go commercial, its president has testified
Greg Brockman said Musk tried to turn it into a for-profit company years ago. (NYT $)
+ Musk allegedly wanted full control so he could raise $80 billion to colonize Mars. (Reuters $)
+ The Tesla CEO claims he intended for OpenAI to remain a non-profit. (BBC)
+ Here’s what happened in week one of Musk v. Altman. (MIT Technology Review)

2 Google and Meta are building AI agents to rival OpenClaw
Google’s Gemini agent will take actions on the users’ behalf. (Business Insider)
+ Meta’s will be powered by its Muse Spark AI model. (FT $)
+ Hustlers are cashing in on China’s OpenClaw AI craze. (MIT Technology Review)

3 Anthropic will spend $200 billion on Google’s cloud and chips
The investment will be spread across five years. (The Information $)
+ It’s part of a broader AI compute war. (Axios) 

4 DeepSeek is nearing a $45 billion valuation
A state-backed “Big Fund” will lead a new investment round in the company. (FT $)
+ Beijing is pushing to build alternatives to Nvidia and OpenAI. (Bloomberg $)
+ Here’s why DeepSeek’s new model matters. (MIT Technology Review)

5 Anthropic is launching AI agents for banks and financial firms
The 10 tools cover a broad mix of financial services tasks. (WSJ $)
+ They’re part of a push to win over Wall Street. (Bloomberg $)

6 Apple will pay $250 million to settle an AI lawsuit
It was accused of misleading iPhone buyers about Apple Intelligence. (BBC)
+ Some iPhone owners are eligible to receive up to $95. (NYT $)

7 Cheap laptops and phones may be disappearing because of AI demand
 Competition for memory chips is driving up gadget prices worldwide. (The Guardian)

8 Google DeepMind workers in the UK have voted to unionize
As a result of Google’s work with the Pentagon. (Wired $)

9 Pennsylvania is suing Character.AI over chatbots posing as doctors
Investigators say the bots claimed to hold medical licenses. (NPR)
+ How well do AI health tools work? (MIT Technology Review)

10 Scientists created a “living” plastic that destroys itself on command
It could help to eliminate microplastics. (Gizmodo)

Quote of the day

“I want AI to benefit humanity, not to facilitate a genocide.” 

—An anonymous Google DeepMind worker tells the Guardian that Google’s work with the Israel Defense Forces had motivated their vote to unionize.

One More Thing

a tiger shark seen underwater with a camera on its flank

COURTESY OF BENEATH THE WAVES


How tracking animal movement may save the planet

For decades, wildlife researchers have dreamed of building an “Internet of Animals”—a big-data system that monitors and analyzes animal behavior to help us understand the planet. Advances in sensors, AI, and satellite technology are now bringing that vision to reality.

Scientists want the system to track 100,000 sensor-tagged animals. They believe it could reveal how species respond to climate change and ecosystem loss—and even predict environmental disasters. Read the full story on how their idea could save our planet.

—Matthew Ponsford

We can still have nice things

A place for comfort, fun and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ Master the art of fried chicken with this definitive chef’s guide.
+ Find out why some birds hop and others walk in this breakdown of avian lifestyles.
+ This vintage Hollywood map shows how California’s landscape stood in for everything from the Nile to the Alps.
+ Here’s a fascinating look at the “Flatbed” airplane that was surprisingly efficient on paper but never left the hangar.