They discovered that antibiotics stimulate bacteria to differentiate into groups of what they describe as vesicle-producing, and protein-receiving cells, and that antibiotic “persisters” with reduced protein synthesis acquire proteins released by their neighbors. The discoveries may help to explain why some bacteria are hard to eliminate, and also point to potential future approaches to improve antibiotic effectiveness.

“Antibiotics are designed to kill bacteria or stop them from growing,” said Christophe Herman, PhD, professor of molecular and human genetics and of molecular virology and microbiology at Baylor. “Yet many times, antibiotics leave behind a small group of survivors. These survivors are not genetically resistant; instead, they temporarily shut down certain parts of their metabolism, entering a dormant-like state that allows them to endure treatment and later regrow. Understanding how survivors form and remain is a major challenge in fighting persistent infections.”

Herman is senior and co-corresponding author of the team’s published paper in Science,” (“Antibiotics stimulate protein transfer to persister cells,”) in which the team further explained, “Protein uptake enhanced the antibiotic persistence of recipient cells, revealing that vesicle exchange promotes bacterial survival during antibiotic treatment.”

Scientists have long known that bacteria can help each other resist antibiotics by sharing genes that provide antibiotic resistance. But as the authors pointed out, “Whereas horizontal gene transfer is known to spread antibiotic resistance genes, far less is understood about the mechanisms and effects of horizontal protein transfer.”

Antibiotic treatment stimulates vesicle production, so for their current study, Herman and colleagues investigated whether bacteria could also directly share proteins. Previous studies had indicated that bacteria can share proteins, but the experimental evidence was not clear. “To directly measure horizontal transfer, we constructed a genetic system in Escherichia coli consisting of a donor and a recipient strain.”

First author Alice X. Wen, a Baylor McNair Scholar in the Medical Scientist Training Program (MD/PhD), working in the Herman lab, further explained, “To detect protein transfer, we designed a sensitive system using the bacterium Escherichia coli. We engineered one group of bacteria (donors) to make a special enzyme called Cre, and another group of the same bacteria (recipients) to contain a genetic ‘switch’ that could only flip if Cre protein entered the recipient.”

Using this system, investigators discovered that when donor and recipient bacteria were grown together, protein transfer occurred but was rare under normal conditions. In contrast, when the bacteria were exposed to low, non-lethal levels of antibiotics, protein transfer increased by thousands of times. “We then investigated how proteins were moving from one cell to another,” Wen said. “We found that the transfer still occurred when donor cells were removed, leaving behind only the liquid in which they had grown. This ruled out direct cell-to-cell contact and pointed to something released into the environment.”

By combining biochemical techniques and advanced microscopy, the team discovered that the proteins were transported by tiny membrane vesicles. These structures, which look like tiny bubbles, are made of bacterial membrane that pinch off from cells and float freely. “Bacterial membrane vesicles, which contain proteins, have been proposed as mediators of horizontal protein transfer,” they pointed out. “Additionally, antibiotic treatment stimulates vesicle production.”

Looking closer at their experimental system, the team found that the recipient cells showed strong signs of dormancy—these cells slowed down protein production, reduced their metabolism, and activated genes associated with persistence, such as HipA. “Recipient cells with high HipA activity were more likely to take up protein-carrying vesicles and survive antibiotic treatment,” Wen said. “When HipA was removed, both protein uptake and survival dropped.”

Protein transfer also helped dormant bacteria survive exposure to lethal antibiotic doses after vesicle transfer; that is, exposing cells to an increased concentration of vesicles before antibiotic treatment led to increased survival. “Protein uptake enhanced the antibiotic persistence of recipient cells, revealing that vesicle exchange promotes bacterial survival during antibiotic treatment,” the authors stated. The results suggested that transferred proteins helped dormant cells endure stress while their own protein production was shut down. “Uptake of key proteins, such as ribosomal components, metabolic enzymes, or DNA repair factors, from active neighbors may help persisters endure proteome-damaging stress despite reduced protein synthesis.”

Herman said, “Our study shows that antibiotics cause a genetically identical group of bacteria to differentiate into two distinct groups: donor cells that respond by releasing protein-filled vesicles, and recipient cells that become dormant but capable of taking up proteins from incoming vesicles, which helps them survive,” Herman said. “This teamwork allows vulnerable members of a bacterial population to persist in the face of a potentially deadly antibiotic attack.”

The researchers are interested in identifying the proteins in vesicles that contribute to recipient persistence. Understanding donor-recipient interactions among bacteria opens new doors in the fight against chronic and persistent infections. In conclusion, the authors stated that their work “… reveals that antibiotics stimulate the differentiation of bacteria into distinct groups of vesicle-producing and protein-receiving cells, which allows antibiotic persisters with decreased protein synthesis to acquire proteins secreted from active neighbors. New strategies to eliminate persisters could be developed by inhibiting or hijacking horizontal protein transfer.”

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The deal would add Bio-Techne’s multiomics offerings, analytical technologies, and integrated workflow solutions to German Merck’s platforms and services in research, bioprocessing and advanced therapeutics, with the aim of creating a combined company capable of helping customers from discovery and translational research through development, testing and commercial manufacturing.

Merck KGaA added that acquiring Bio-Techne would directly deliver on its mid- to long-term strategic agenda, which focuses on adding to its high-growth value drivers, integrated workflows, platformed capabilities—as well as scaling and sourcing innovation through merger-and-acquisition (M&A) deals like the Bio-Techne transaction.

That transaction is the latest in a series of acquisitions for Merck KGaA totaling more than $35 billion, including in the U.S. with acquisitions such as Millipore (for about $7 billion in 2010), as well as Sigma-Aldrich (for $17 billion in a deal announced in 2014 and completed the following year), Versum Materials (for €5.8 billion [about $6.6 billion] in 2019), and last year, SpringWorks Therapeutics (for $3.95 billion).

Merck KGaA said it would also benefit from Bio-Techne’s position as a leading provider of materials, analytics, and process technologies to cell therapy developers. Bio-Techne expects to acquire the ownership in Wilson Wolf it does not own immediately following the end of calendar year 2027 under the terms of a two-part forward contract between the company and Wilson Wolf, a manufacturer of cell culture devices, including the G-Rex product line. Bio-Techne holds 19.9% of Wilson Wolf that it acquired in the fiscal year that ended June 30, 2023.

Merck KGaA employs more than 14,000 people in the U.S. across over 70 company and customer sites.

The $11.3 billion Bio-Techne acquisition is the new third largest biopharma merger-and-acquisition (M&A) deal announced so far this year, behind the €10.7 billion ($12.268 billion) cash buyout offer for Italian-based Recordati being pursued by CVC Capital Partners and Groupe Bruxelles Lambert, which aim to take the company private; and Sun Pharmaceutical Industries’ planned $11.75 billion purchase of Organon, the women’s health drug developer spun out of Merck & Co., in a deal expected to close in early 2027.

The previous third-largest M&A deal this year, now fourth-largest, is the $10.9 billion AbbVie purchase of Apogee Therapeutics, announced on Monday. The fifth largest deal is GlaxoSmithKline (GSK)’s planned $10.6 billion buyout of Nuvalent,  announced June 9 and expected to close in the third quarter.

“Outstanding fit”

“Bio-Techne is an outstanding fit that directly supports our strategic direction focused on delivering cutting-edge products and solutions across the entire industry value chain—from lab customers to those manufacturing in the biotech and pharmaceutical industries,” Kai Beckmann, chairman of the executive board and group CEO of Merck KGaA, Darmstadt, Germany, said in a statement.

“By combining Bio-Techne’s scientific depth, innovation engine and differentiated portfolio with the global scale, manufacturing excellence and customer reach of Merck KGaA, Darmstadt, Germany, we are in a strong position to address some of the most important opportunities in life sciences and support our customers in accelerating the next generation of scientific discovery and therapeutic innovation. This positions us to deliver compelling strategic and financial benefits for shareholders, customers and employees,” Beckmann added.

Those benefits, according to German Merck, include immediate accretion to the company’s earnings before interest, taxes, depreciation, and amortization (EBITDA) pre margin for both the Group as a while and its Life Science business segment upon closing of the acquisition deal.

The Life Sciences segment finished last year with €8.98 billion ($10.36 billion) in revenue.  Merck KGaA does not break down its businesses further than its three segments, which also include healthcare (drug development, focused on oncology, neurology and immunology, and “global health” treatments such as for malaria) and electronics (high-tech materials).

The deal is expected to close by late 2026 or early 2027, subject to satisfying customary closing conditions that include obtaining regulatory approvals and approval by Bio-Techne shareholders.

Bio-Techne’s board of directors and the corporate bodies overseeing Merck KGaA, Darmstadt, Germany, have already approved the transaction, which will also add to earnings per share (EPS) by year three after closing, German Merck said.

€140M in “synergies”

Merck KGaA said it will carry out cost-cutting “synergies” of approximately €140 million (about $159.3 million) that are expected to be fully realized by the third year after closing.

The planned acquisition will be funded through a combination of existing cash on hand and proceeds from new debt, Merck KGaA said, adding that it will preserve its “strong” investment-grade credit rating.

For Minneapolis-based Bio-Techne, the acquisition is expected to increase its geographic and omnichannel access for its customers through integration of its offerings with those of Merck KGaA through a synergistic platform.

Bio-Techne has more than 3,000 employees, with approximately 2,300 employees based in the U.S. The company operates 34 global locations and 15 manufacturing facilities across the U.S., Canada, the U.K., Switzerland and China, and generated net sales of more than $1.2 billion in the fiscal year that ended June 30, 2025.

A leader in recombinant proteins with a half-century of heritage in next-generation R&D and new modalities, Bio-Techne said it would bring to German Merck a globally recognized portfolio of cytokines, growth factors, antibodies, and immunoassay kits. Bio-Techne is expected to strengthen the analytical and bioprocess solutions of Merck KGaA by adding to its offerings ProteinSimple, a leader in automated protein detection and analysis instruments. Bio-Techne added that its RNAscope and related in situ hybridization technologies would strengthen the capabilities of Merck KGaA, in spatial biology and diagnostics.

“For 50 years, Bio-Techne has enabled scientific breakthroughs across proteomics, spatial biology, and novel therapeutics,” stated Kim Kelderman, president and CEO of Bio-Techne. “This transaction is a testament to the remarkable company our team has built and to the enduring value we create for our customers and stakeholders.”

Muted enthusiasm

Bio-Techne investors appeared to share only muted enthusiasm for the deal, as the company’s shares traded on Nasdaq rose just 19.8% to $70.53 as of 12:48 pm ET, from Wednesday’s close of $58.88 per share. Merck KGaA shares traded on XETRA rose 4.93% to €147.00 ($167.25).

Puneet Souda, senior managing director, life science tools and diagnostics, and a senior research analyst with Leerink Partners, offered a possible explanation in a research note today: “The acquisition appears to be only a 24% premium to yesterday’s close and 26x the Street’s forecast for FY27 [enterprise value]/EBITDA compared to 16x for its LST [life science technologies] peer group.”

“We see the acquisition multiple undervaluing what is a highly accretive asset in our view,” Souda wrote. “Historically, TECH [Bio-Techne’s stock ticker] traded at much higher multiples given their highly accretive consumables profile (80%+ consumables) of consistent 70%+ gross margins and operating margin potential.”

One rival company in particular may benefit from the deal, Souda said: “The announcement is likely to be viewed positive for peer LST companies today, especially RVTY [Revvity] in our view.”

At $73 per share cash, the deal price represents a 36% premium to Bio-Techne’s one-month volume weighted average trading price.

“As part of Merck KGaA, Darmstadt, Germany, we will have greater scale and expanded capabilities to accelerate innovation and deepen our impact. Together, we will empower our customers to tackle the most important challenges in science and healthcare, helping to improve outcomes worldwide,” Kelderman added.

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Those were some of the major themes that emerged from a town hall that took place at this year’s Biotechnology Innovation Organization (BIO) meeting in San Diego, which featured members of the current FDA leadership team. 

John Crowley, BIO president and CEO, moderated the discussion with the acting directors of Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and the acting chief of staff at the FDA. During the hour-long conversation in a room packed to the hilt with BIO attendees, they spoke about the agency’s current priorities and its plans to increase its headcount, among other initiatives. 

Much of the discussion centered on ongoing plans to stabilize the agency’s workforce following the massive reduction in staffing implemented by the Department of Government Efficiency (DOGE) as well as departures of several leaders in rapid succession. The panelists acknowledged the disruptions to operations, the loss of institutional knowledge, and the past unpredictability at the agency, but did not dwell on it.  

The consensus seems to be that stabilizing the agency’s workforce is an important prerequisite for successfully launching several planned initiatives. In fact, Michael Davis, MD, PhD, acting director of CDER, noted that this has been one of his top priorities. His initial efforts were aimed at “fortifying the center and specifically the workforce” as well as finding ways to retain staff retention and boost recruitment.  

The conversation covered plans to improve overall morale, boost staff numbers, and to refocus on executing the agency’s mission. That includes implementing “some initiatives that were announced” or “have been in discussion for some time” and thinking through what is needed to support those programs, said Lowell Zeta, JD, acting chief of staff at the FDA.  

Karim Mikhail, CBER acting director, stated that in addition to working through existing submissions, his team is also planning for future challenges and ways to address them quickly to avoid backlogs.  

In terms of recruitment, the agency is looking to fill more than 2,200 authorized positions across the agency, Zeta said. About 600 people are currently being onboarded as part of the hiring push “so we feel like we’re making good progress.” CDER’s Davis said he is open to “bringing back good people” who would be interested in returning, as well as recruiting new candidates interested in public health who have the requisite skills.  

The agency is also intentional about its efforts to minimize attrition, including offering opportunities for staff to meet with leadership to discuss challenges and support needs. And those efforts may be working. In CDER, for example, staff attrition has slowed to its historical rate. 

Modernizing clinical development 

 Earlier this week, the FDA announced a slate of early actions aimed at “modernizing” and expediting early and late-stage clinical development. These were unveiled as part of Operation TrailBlazer, a U.S. Department of Health and Human Services initiative. The proposed changes are aimed at streamlining Phase I submission requirements so that drug developers have more clarity about what is necessary at this stage and what can be deferred. The agency is seeking public comments from the scientific community on some of these proposed actions.  

 The panelists positioned the proposed actions as a fundamental shift from the traditional comprehensive review approach to drug development towards a more adaptive design process. “Everybody understands the challenge we have,” Mikhail said. “We have incredible rigor” but “we need to make sure that we’re also as fast as we are rigorous.”   

Importantly, the agency is also seeking to make patient perspectives more central to the drug development process. Asked by Crowley how this will work, Davis shared an anecdote about taking part in a listening session coordinated by the FDA for parents of patients with the rare disorder, Smith-Magenis syndrome. Asking questions like “What is it like to have children with this condition? What effect does that have on the children? What effect does that have on the family dynamic?” makes it “more real when connecting the data to what families and patients are experiencing.”  

China crisis  

Another major theme here and indeed throughout the conference was maintaining U.S. competitiveness and leadership in biotech. The panelists acknowledged China’s current competitive advantage in terms of the development of its biotech infrastructure and the reality of clinical trials moving overseas due to increasing costs and the regulatory burden in the U.S.  

As Crowley put it, “China frankly is eating our lunch” and “we’re forcing so many of our innovators and companies to go to China” for early-stage clinical trials. In this climate, he noted that the FDA has a crucial role to play.  

The FDA has traditionally been viewed as the “guardian of public health, which is an important, primary role,” Crowley said, but “this notion of being a beacon of innovation and U.S. competitiveness tied to our national security is a new and important role.” The panelists also highlighted the growing use of artificial intelligence tools, digital health technologies, and wearable sensors as an important source of innovation within the agency

The FDA has recently signaled a willingness to revisit decisions it made over the past several months if those companies whose applications were rejected choose to resubmit them. “I want to make sure that we’re getting the decisions right in a way they have the confidence of the American public,” Davis said. “I think the public really trusts the FDA to make the right decisions” and “doing this closely with the multidisciplinary expert staff that we have.” 

To be clear, the agency is not going to approve everything, Mikhail said. But it will make sure that patient safety is prioritized, and that a multidisciplinary group of scientific experts at the FDA provide critical input.  

“I think everybody wants what is best for the patients,” he said. So “making sure that safety is paramount” and that “everybody is on the same page with regards to that second chance.”  

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InduPro will combine its proprietary bispecific antibody capabilities with Lonza’s ADC platform. By leveraging these complementary technologies, the companies aim to develop differentiated therapeutic approaches designed to address complex diseases such as cancer, where precision targeting and efficacy remain critically important, notes Jan Vertommen, vice president of commercial development, advanced synthesis, Lonza.

“By combining our expertise in bioconjugation technologies and manufacturing with InduPro’s innovative proximity guided antibody platform, we reinforce our commitment to enabling our licensing partners and supporting the advancement of next-generation ADC programs,” says Vertommen.

“This agreement represents an important step in advancing our pipeline of proximity-driven bispecific ADCs,” adds Prakash Raman, CEO, InduPro. “By combining InduPro’s ability to identify novel, disease-specific co-target pairs with Lonza’s industry-leading ADC technologies, we aim to develop differentiated, first-in-class therapeutics that improve selectivity, expand therapeutic windows, and ultimately deliver better outcomes for patients with hard-to-treat tumors.”

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“We’ve known for a long time that a high-cholesterol diet reduces the liver’s ability to clear cholesterol from the blood, but we didn’t fully understand why,” said Alan Saltiel, PhD, professor of medicine at UC San Diego School of Medicine and director of the UC San Diego/UCLA Diabetes Research Center. “This new discovery explains a critical piece of that puzzle.” Saltiel is senior author of the researchers’ published paper in Nature, titled “Dietary cholesterol activates a Ral-dependent pathway driving LDLR turnover,” in which they concluded, “Together, our findings reveal a Ral-dependent signalling pathway as a key regulator of LDLR turnover and cholesterol homeostasis.”

Disruptions in cholesterol homeostasis are closely linked to an increased risk of atherosclerosis and cardiovascular disease (CVD), the authors wrote. “Elevated low-density lipoprotein cholesterol (LDL-C) significantly contributes to CVD by promoting the formation of atherosclerotic plaques in arteries.”

The liver is the main organ involved in removing cholesterol from the blood so it can be broken down and used elsewhere. This is done through LDL receptors (LDLRs), which sit on the surface of liver cells and act like docking stations, grabbing LDL cholesterol from the bloodstream and pulling it inside the cell for processing. “LDLRs have a crucial role in the uptake of LDL-C from the circulation by hepatocytes,” the investigators continued. The more LDL receptors on liver cells, the more cholesterol gets cleared from the blood, which is why most cholesterol-lowering drugs, such as statins or PCSK9 inhibitors, work by preserving or increasing the number of these receptors. However, the team noted, such treatments have their limitations. “The molecular switches that coordinate LDLR trafficking and turnover in response to nutritional cues, including high dietary cholesterol, remain poorly defined.”

The new research, carried out in mice and in human cells, reveals a previously unknown mechanism that quietly works against the cholesterol removal process, slowly reducing the number of LDL receptors and contributing to high blood cholesterol. The team found that this process begins when a protein called Ral—which Saltiel has previously studied in fat cells—is activated by high dietary cholesterol. “We describe here a previously unrecognized role for Ral signaling in orchestrating LDLR cellular trafficking and lysosomal routing in hepatocytes under chronic cholesterol stress,” the team stated.

Their studies showed that the more Ral is activated, the fewer LDL receptors remain available to clear cholesterol from the blood. This depletion process ultimately relies on a lysosomal protease enzyme called cathepsin A (CTSA). They further explained, “Ral engages the endocytic RalBP1–REPS1 complex to promote LDLR internalization and lysosomal routing, where LDLR is degraded by the lysosomal protease cathepsin A (CTSA).”

The researchers also found that blocking CTSA with a selective small molecule inhibitor (SAR164653) was enough to stabilize LDL receptors and dramatically lower circulating LDL cholesterol in mice. “Pharmacological inhibition of CTSA activity increases hepatic LDLR function and improves cholesterol clearance, offering a potential new therapeutic strategy for hypercholesterolaemia and cardiovascular disease,” they stated.

“There’s still a real need for new cholesterol-lowering options, since some people can’t get to safe levels even with the drugs we have now,” said Saltiel. “This new pathway we discovered is completely separate from anything that existing drugs target, so it gives us a new opportunity to fill that gap.”

After a fundamental biological breakthrough, it typically takes significant additional research to find drugs that target it. However, in this case, a CTSA inhibitor has already been through the early stages of drug development, with the initial goal of treating heart failure. While it was eventually shelved for strategic reasons, the drug had previously advanced to a Phase I clinical trial, where it was successfully tested for safety.

This discovery suggests that the investigational drug is already ready for testing in a Phase II trial for high cholesterol. “Luckily, there’s an experimental drug sitting on the shelf that’s already been shown to be safe in humans,” said Saltiel. “We hope to test whether this might be effective by conducting a clinical trial, which could potentially bring a new treatment option to patients much sooner than would have been expected.”

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Huntington’s disease is a fatal, progressive genetic disorder that gradually destroys brain cells. It usually begins between the ages of 35 and 50 with symptoms that include involuntary movements, difficulty thinking and planning daily tasks, and mood changes such as depression. If successful, this therapy could prolong independent living and significantly reduce long-term care costs.

“This clinical trial highlights the important role that an interdisciplinary academic and clinical team together with the HD families, plays in advancing medicine,” said Leslie M. Thompson, PhD, professor of psychiatry and human behavior at UC Irvine. “We are grateful to our patients and their incredible families for their bravery to provide hope for others with very few options.”

The first patient received the intervention at UCI Health Irvine (home to Orange County’s first adult bone marrow/stem cell transplant and cellular therapy program) in May. A second patient is scheduled to receive the intervention in July.

“The first patient intervention went very well. To date, they haven’t reported any serious adverse events,” said Ravi Rajmohan, MD, UCI Health neurologist. “This trial may help us move one step closer to a future with available treatments that could potentially slow the progression of Huntington’s disease.”

The therapy, hNSC-01, uses pluripotent neural stem cells derived from embryonic stem cells, which were manufactured through the UC Davis GMP facility. In animal studies, the cells have been shown to protect existing brain cells, replace lost cells, rebuild impaired brain circuits, release helpful proteins, such as brain-derived neurotrophic factor (BDNF), and reduce harmful protein accumulations that damage brain cells. The stem cells were also shown to be safe over long periods in mice.

The clinical trial will enroll 21 people ages 18 to 65 with early-stage Huntington’s disease. Twelve participants will be enrolled into a Phase Ib dose-escalation group and nine in a Phase IIa expansion group.

The stem cells are implanted during a roughly six-hour surgical procedure done under general anesthesia. While lying face down in an MRI scanner, the patient receives stem cells implanted directly into the striatum deep in the brain, using a purchased proprietary therapy-enabling platform for navigation and surgical delivery. Damage to the striatum, which is responsible for motor control, decision-making, motivation and more, causes Huntington’s disease symptoms. Subjects will be closely monitored for safety as well as preliminary signs of potential benefit.

The clinical trial is made possible by a $12 million grant from the California Institute of Regenerative Medicine (CIRM), and the trial is coordinated through the UC Irvine Alpha Clinic.

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At the 2026 BIO International Convention in San Diego this week—which drew “roughly 20,000 attendees,” according to the organizers—Crowley outlined a vision for the future of biotechnology centered on accelerating clinical research, embracing artificial intelligence, and maintaining U.S. leadership in a rapidly evolving global bioeconomy.

The grassroots gauntlet

Crowley’s personal journey as a father shaped his path into biotechnology. In the late 1990s, two of his children were diagnosed with a rare form of muscular dystrophy. He left Bristol-Myers Squibb’s marketing department to co-found a biotechnology company with an Oklahoma academic researcher over scientific progress.

The struggle to get funding was immense. Crowley reflected on his first BIO convention in 2000 amidst the excitement of the Human Genome Project: “I came and there were tens of thousands of people partnering as there is today, still a quarter of a century later. Being the 31-year-old CEO of a small startup in Oklahoma City with no money, literally nobody signed up to meet with me and nobody accepted my meeting request.”

Crowley recalled going to the main stage, where a gentleman, rendered quadriplegic through a horse accident, came out on the stage and said, “Biotechnology—it’s a great big word that just means hope. It’s my hope that someday I can hold my wife’s hand on the beach or throw a ball to my kids.”

Crowley, empty-handed, returned to Oklahoma City and was able to scrounge up the funds for his startup, Novazyme Pharmaceuticals, which was ultimately funded by home equity loans and credit card advances to develop rare disease treatments. Just one year later, Novazyme was acquired by Genzyme Corporation for $225 million.

The experience engrained in Crowley two main concepts: first, developing therapeutics doesn’t always start in big pharma but, rather, often has grassroots origins; second, and relatedly, it’s an almost impossible battle for anyone outside of big pharma to fight.

“That’s the way so much of our science happens,” Crowley said. “It comes out of great universities, and it’s a scientist and entrepreneur—and increasingly, families, patients, and patient advocates—leading the way and going through the whole journey, running that gauntlet of making medicines.”

Modernizing clinical trials and accessible AI

To achieve the vision of maximizing the development and reach of biotechnology, Crowley identified a handful of problems, including the need to change the current system of clinical trials. Crowley praised the FDA’s new “Project Trailblazer” initiative to modernize experimental therapy human testing. He argued that clinical trials have become excessively burdensome and costly, limiting innovation and delaying patient access to new treatments.

Over the past year, Crowley and BIO have worked with regulators and industry stakeholders to identify development bottlenecks. “The FDA needs to continue to be the gold standard of the world,” he said, while emphasizing that modernization is necessary to make the agency a stronger “beacon of innovation.” BIO has proposed several reforms, including measures designed to streamline trial approvals and improve the efficiency of regulatory review.

Describing recent discussions among BIO’s board of directors, which includes executives from both major pharmaceutical companies and small biotechnology startups, Crowley said there were two major strategic topics that emerged that dominated the conversation: China and AI.

For AI, the question wasn’t about whether it could revolutionize biotechnology; rather, it had to do with making AI capabilities accessible to companies of all sizes. Crowley noted a major disparity. “Our biggest companies have the resources and the focus to think about AI. They’ve got hundreds or more people focused on this. Our small companies don’t have those resources,” he said.

Crowly continued, “It’s also a challenge because in our industry we would work on such long timelines, and it’s hard for an entrepreneur and biotech of a small or a mid-sized company who’s invested years to get to…starting Phase III, and all of a sudden you’ve got this massive disruptive technology. That’s exactly what AI is going to be.”

The solution, according to Crowley, is for BIO to be at the forefront to enable the rapid implementation of AI into drug development paradigms, clinical trials, and the regulatory review process.

Challenging China

Crowley’s most stressed point was that the United States must remain competitive against growing international rivals, particularly China. “Drug development has just gotten too costly and burdensome, and it takes too much time,” said Crowley. In this [global] bioeconomy where we need to compete and outcompete countries like China, these are reforms that are needed.”

He characterized biotechnology as a matter of national security and argued that the United States should treat the industry as a strategic asset. While supporting bipartisan efforts in Washington to strengthen domestic biotechnology capabilities, he cautioned against policies that could create unintended consequences or limit access to potentially life-saving technologies.

“The world is a better, safer, healthier, and more prosperous place when the United States and its allies continue to lead in biotechnology,” Crowley said.

China has identified biotechnology as a strategic priority through multiple national development plans and has invested heavily in scientific infrastructure, manufacturing capacity, and research capabilities. Crowley argued that the most effective response is not isolation but improving the competitiveness of the U.S. innovation ecosystem.

Crowley repeatedly returned to what he described as “man-made problems” holding the industry back. While scientific challenges will always exist, Crowley said barriers such as complex regulations, insufficient research funding, delays in patient access, and rising out-of-pocket healthcare costs are obstacles that policymakers can address. “We can’t come to this convention and cure every cancer,” he said. “But if we get together with policymakers and lawmakers, we can pretty quickly solve a lot of these man-made problems if we have the will.”

50 years down, 50 years ahead

As biotechnology celebrates more than 50 years of innovation, Crowley argued that the industry’s future will depend not only on scientific breakthroughs but also on its ability to modernize the systems that govern how those breakthroughs reach patients.

“I hope you see, when you’re here at this convention, that it captures that entrepreneurial spirit,” said Crowley. “It has to be grounded in great science and research, and it’s an exciting time to be in biotech, not just reflecting about all our successes and our many failures and challenges along the way in 50 years and looking out in the months, years, and next 50 years about what biotechnology can do to extend and enhance life and to alleviate an enormous amount of human suffering.”

With advances in gene editing, genomic medicine, artificial intelligence, and cell therapies accelerating simultaneously, Crowley believes the next era of biotechnology could surpass anything seen before—provided the industry can remove the barriers standing in its way.

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Researchers led by Sang-Ki Kim, DVM, PhD, professor, Kongju National University in Korea, and CSO at Vaxcell Bio, along with Seung-Hwan Lee, PhD, professor, University of Ottawa, appear to have solved that bottleneck with an engineered version of the feeder cell line known as ARH-77, a B-lymphoblast cell line that stimulates NK cells. Even in its unmodified form, ARH-77 cells expanded NK cells extracted from peripheral blood samples 681-fold after 28 days. In contrast, K562, the cell line typically used, enabled 155-fold expansion during that time.

That expansion pales in comparison to that of the engineered cell line. The now-modified ARH-77 cells, modified to express four specific stimulatory ligands, expanded NK cells by 101,241-fold in 28 days. Making the same modifications to the K562 cells, however, improved production only 4.4-fold. In each of the cell lines, purity and cytotoxicity were considered equivalent.

Kim, Lee, and colleagues chose the ligands B7-H6, CD137L, IL-15, and IL-15Rα to provide multi-axis stimulation to enhance NK cell activation and proliferation as well as to enhance persistence. For example, B7-H6 stimulates production and exhibits early cytotoxic benefits, but those benefits dissipated by week four. CD137L appears to compensate for that attenuation, the scientists report. Notably, the feeder performance was consistent across donors.

While these ligands were more effective than other ligands the team considered, they stress that more work is needed to “formally establish the added value of each ligand.” They also want to evaluate the engineered ARH-77 in terms of in vivo persistence and anti-tumor activity against additional models. Large-scale manufacturing constraints also should be considered in future studies.

Because feeder cell performance is considered stable across the donor population, Kim and Lee suggest their engineered ARH-77 cell line may be a reliable option for NK cell expansion as therapeutic production scales up. As the scientists note, “These findings establish ARH-77 as a promising alternative feeder cell platform that could enhance the scalability, consistency, and potency of allogeneic NK cell manufacturing for clinical adoptive immunotherapy.”

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The fully recoded E. coli, designed to use only 61 codons to synthesize proteins, is now being rolled out as a new method for manufacturing peptides with non-natural chemistries.

That’s according to Constructive Bio, the company that recoded the E.coli and now hopes this synthetic strain will transform the production of some high-volume hard-to-manufacture protein/peptide therapeutics.

“Our key message is that we’re able to produce long peptides containing non-canonical amino acids to deliver therapeutic proteins at scale by biomanufacturing,” explains Rob Salmon, PhD, head of bioprocess at Constructive Bio.

“And our key differentiator is there’s currently a market in, for example, weight loss drugs.”

According to Salmon, glucagon-like peptide-1 (GLP-1) agonists for weight loss are currently produced using chemical synthesis approaches such as solid phase peptide synthesis, which is hard to scale and generates high volumes of toxic waste.

By contrast, the synthetic E. coli strain can potentially produce these peptides using fermentation via standardized industrial processes, he says.

“We want to fit into standardized industrial unit operations and, through that, scale to thousands of liters of product that we can sell to the market,” he explains.

The strain was developed as part of research into reducing the number of codons needed to synthesize proteins in an organism from 64 to 61, allowing slots for three new non-canonical amino acids, according to the company.

Since then, the optimized strain has been taken through some industrial fermentations and demonstrated promising titers, he explains, adding that he will present results at the upcoming Bioprocessing Summit in Boston.

“We’re challenging some of the assumptions from chemists that biology can’t be used to do this,” he says.

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According to Kevin Cyrys and Robert Zweigerdt, PhD, both of Hannover Medical School in Germany, the field has entered a new phase. Rather than simply demonstrating that stem cells can be grown in bioreactors, researchers are increasingly focused on creating robust production platforms that can deliver consistent quality across facilities and patient populations.

“Human pluripotent stem cells can serve as an unlimited, renewable ‘raw material’ for essentially any therapeutic cell product,” the authors wrote, highlighting the technology’s potential to overcome limitations associated with donor-derived tissues and organs.

The manufacturing challenge is substantial. While some therapies, such as treatments for age-related macular degeneration, require only tens of thousands of cells per dose, others may demand billions of cells for a single patient treatment. Conventional laboratory-scale methods are unlikely to meet such requirements efficiently.

To address this gap, developers are increasingly adopting three-dimensional suspension cultures in bioreactors. Compared with traditional two-dimensional cell culture systems, bioreactors provide tighter control over temperature, oxygen levels, pH, and carbon dioxide while supporting automated, closed-system manufacturing compatible with good manufacturing practice (GMP) standards.

The field has already demonstrated notable progress across multiple therapeutic areas. Researchers have developed scalable processes for producing cardiomyocytes, pancreatic islet cells, hepatocyte-like cells, neural tissues, and immune effectors derived from hPSCs. Some cardiac manufacturing platforms have reported production of billions of cardiomyocytes in liter-scale bioreactors, while immune-cell manufacturing programs have successfully expanded induced pluripotent stem cell-derived natural killer cells in 1–10 L systems while maintaining product quality.

Yet scaling production involves more than increasing cell yields. “Industrial-scale success depends on more than headline totals,” Cyrys and Zweigerdt note, citing the importance of volumetric productivity, production time, reproducibility, and integration of expansion, differentiation, and downstream processing into a coherent GMP-ready workflow.

Looking ahead, Cyrys and Zweigerdt argue that the next generation of stem-cell manufacturing will be defined by data-driven process control. They predict that AI-enabled systems will help move the industry from retrospective quality analysis toward real-time decision support, ultimately improving comparability between batches and strengthening product definitions across manufacturing networks.

Despite ongoing challenges involving cost, quality control, and regulatory compliance, the authors conclude that stem-cell bioprocessing has already crossed an important threshold. Scalable culture systems are no longer the primary obstacle. Instead, the focus has shifted toward engineering reliable industrial processes capable of transforming complex stem-cell biology into reproducible therapeutic products.

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