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The recent collaboration between Lonza’s Synaffix and BigHat Biosciences exemplifies the growing convergence of biotechnology with machine learning to produce next-generation cancer therapies. < Back Advancing the Future of ADCs through Machine Learning: Lonza’s Synaffix and BigHat Biosciences Collaboration The recent collaboration between Lonza’s Synaffix and BigHat Biosciences exemplifies the growing convergence of biotechnology with machine learning to produce next-generation cancer therapies. Antibody-drug conjugates (ADCs) are at the forefront of oncology treatment, offering a targeted therapeutic approach that delivers potent drugs directly to cancer cells, thereby minimizing systemic toxicity. This partnership combines BigHat’s ML (machine learning)-based antibody design platform, Milliner™ , with Synaffix’s proprietary ADC technology to develop a highly differentiated, effective, and safe ADC pipeline. Synaffix and BigHat Biosciences: Pioneers in ADC Innovation ADCs are designed to selectively deliver cytotoxic agents to cancer cells by harnessing the specificity of antibodies. However, achieving both selectivity and efficacy remains a challenge due to the inherent complexity of the antibody-drug conjugate structure. This is where Synaffix’s ADC technology platform becomes instrumental. Comprised of GlycoConnect™ , HydraSpace® , and toxSYN® technologies, the Synaffix platform provides a comprehensive toolkit that optimizes ADC drug-like properties and enhances efficacy and tolerability. Lonza's acquisition of Synaffix in June 2023 further strengthens this offering, creating an integrated, end-to-end service that accelerates the path from DNA to Investigational New Drug (IND) application. Synaffix's GlycoConnect™ technology provides site-specific payload attachment, utilizing antibody glycan structures to increase stability. This approach, alongside HydraSpace®, which includes a polar spacer to enhance therapeutic index, and toxSYN®, which features a suite of potent cytotoxic agents, positions Synaffix as a leading player in ADC development. These technologies collectively aim to maximize therapeutic index—a crucial parameter in ADC efficacy, denoting the balance between therapeutic effect and side effect profile.\ The Role of Machine Learning in ADC Development BigHat Biosciences brings a powerful AI/ML-driven platform, Milliner™ , to this collaboration, with the potential to redefine ADC design and production speed. Traditional antibody engineering processes can be time-consuming and resource-intensive, requiring extensive laboratory work to develop antibodies with optimal biophysical properties. Milliner™ accelerates this process by integrating synthetic biology with advanced ML models, allowing rapid iteration and optimization of antibody candidates. This platform streamlines antibody design, enabling the development of antibodies with complex functions tailored to withstand the demands of drug conjugation without compromising therapeutic efficacy. Through this collaboration, Synaffix’s GlycoConnect™ technology benefits from BigHat’s precisely engineered antibodies, optimized for stable payload attachment and high binding affinity to target antigens. This union of ML and ADC technology not only facilitates the rapid progression of BigHat’s ADCs but also enhances their therapeutic potential by creating more robust, stable, and effective antibody-drug conjugates. Toward a Fully Integrated ADC Development Pathway The collaboration enables BigHat to leverage Lonza's full suite of ADC services, from antibody production to clinical trial supply. This integration allows BigHat to develop ADC candidates efficiently, reducing the timelines traditionally required for IND-enabling studies. The pathway, facilitated by Lonza’s state-of-the-art facilities, includes bioconjugation, drug product filling, and clinical batch production, all under a single quality system. This seamless, vertically integrated approach underscores Lonza’s commitment to accelerating ADC pipelines and helping biotech partners bring transformative therapies to market more swiftly. The demand for ADCs in the oncology sector continues to rise, spurred by the pressing need for safer, targeted treatments. However, manufacturing and development bottlenecks remain, as the complexity of ADCs requires specialized knowledge and infrastructure at every step of production. The integration offered by Lonza through Synaffix’s platform is a significant advantage, providing companies like BigHat with a streamlined path from initial design to clinical readiness. With Lonza’s recent facility expansion to handle high-potency vial filling, the infrastructure is in place to meet increasing market demands while maintaining the highest quality standards. Potential Impact of the Collaboration on ADC Therapeutics This partnership between Synaffix and BigHat Biosciences has implications far beyond individual drug candidates, potentially influencing the future of ADCs across the oncology landscape. By combining Synaffix’s established technology with BigHat’s AI-driven antibody discovery, the collaboration can produce ADCs that deliver drugs more precisely to tumor cells, thus enhancing both safety and efficacy. This approach directly addresses the unmet medical needs in difficult-to-treat cancers, where traditional therapies often fail due to limited selectivity and high toxicity. With Milliner™ , BigHat can continuously refine and optimize antibodies, leveraging ML to minimize the attrition rate of ADC candidates during preclinical and clinical stages. As ADCs are notoriously challenging to develop, with only a limited number of approved ADCs on the market, such advances in antibody design can lead to higher success rates, faster development timelines, and more accessible treatments for patients. Conclusion The collaboration between Lonza’s Synaffix and BigHat Biosciences is a notable advancement in the ADC field, showcasing how the synergy of machine learning and cutting-edge bioconjugation technology can propel next-generation oncology therapies. Synaffix’s platform offers a streamlined solution for developing ADCs with high stability, selectivity, and safety, while BigHat’s ML-powered Milliner™ platform provides a faster, more effective pathway to antibody design and optimization. This partnership not only strengthens each company’s competitive edge but also highlights the transformative potential of integrating biotechnology with artificial intelligence in cancer treatment innovation. As ADC technology continues to evolve, collaborations such as this set the stage for a future where AI-enhanced biologics bring safer, more effective therapies to patients worldwide. Author BioFocus Newsroom Previous Next

Strategic partnerships in immuno-cncology propel Innovation, highlighting ProBio’s role in the $3.3 billion LM-299 cancer therapy breakthrough. < Back GenScript’s ProBio Pioneers Exciting Innovation in Immuno-Oncology Strategic partnerships in immuno-cncology propel Innovation, highlighting ProBio’s role in the $3.3 billion LM-299 cancer therapy breakthrough. The announcement that ProBio, a subsidiary of GenScript Biotech, has successfully licensed its PD-1 new molecular entity (NME) to LaNova Medicines marks a significant milestone in the biotech industry's ongoing battle against cancer. This collaboration, bolstered by LaNova’s subsequent $3.3 billion agreement with Merck & Co. for the development of the PD-1/VEGF bispecific antibody (LM-299 program), exemplifies the transformative power of strategic partnerships and innovation in immuno-oncology. The Role of PD-1 in Cancer Therapy The licensed PD-1 molecule developed by ProBio represents a cornerstone in next-generation cancer treatments. Programmed death-1 (PD-1) inhibitors are integral in immunotherapy, empowering the immune system to recognize and combat cancer cells. By pairing PD-1 with vascular endothelial growth factor (VEGF) inhibition in a bispecific antibody, LaNova aims to create a dual-action therapy capable of modulating the tumor microenvironment while directly enhancing immune response. This approach aligns with the broader industry trend of advancing combination therapies to tackle complex cancers more effectively. ProBio’s Business Model: A Competitive Edge ProBio’s integrated Contract Development and Manufacturing Organization (CDMO) model sets it apart from competitors. By combining the development of proprietary NMEs with collaborative process development and manufacturing, ProBio positions itself as a partner of choice for biotech companies aiming to bring novel therapies to market. The success of this partnership with LaNova not only reinforces ProBio’s commitment to cutting-edge research but also showcases its ability to execute high-value deals, such as the Merck-LaNova agreement. The financial implications of this partnership are significant. Beyond immediate revenue projections, the collaboration is poised to generate long-term value by demonstrating the scalability and market potential of ProBio’s innovative molecules. This reinforces its leadership in the immuno-oncology CDMO space. Strategic Growth for GenScript and ProBio The financial boost from the LaNova-Merck deal aligns with GenScript’s strategic plans to expand ProBio’s global manufacturing footprint, particularly at its Hopewell, NJ site. Such expansions are crucial for meeting the rising demand for advanced biologics and ensuring the company remains competitive in a fast-evolving landscape. GenScript’s diversified business model, encompassing life sciences, biologics manufacturing, and synthetic biology, provides a robust platform for sustained growth. The company’s reputation, supported by its extensive customer base and substantial contributions to scientific literature, underscores its ability to deliver high-quality products and services. Implications for the Biotech Industry This development exemplifies a broader trend in the biotech industry: the increasing reliance on collaborative ecosystems to drive innovation. Companies like ProBio and LaNova leverage complementary strengths, from early-stage molecule development to late-stage commercialization, accelerating time-to-market for potentially life-saving therapies. Moreover, the agreement underscores the growing interest in immuno-oncology as a therapeutic area with both high clinical impact and lucrative market potential. The PD-1/VEGF bispecific antibody highlights the shift toward multifunctional biologics, which hold the promise of addressing unmet medical needs in oncology. The licensing of ProBio’s PD-1 molecule and the subsequent deal between LaNova Medicines and Merck exemplify the biotech industry's ability to translate scientific innovation into meaningful therapeutic advances. By fostering collaborative partnerships and strategically expanding its capabilities, GenScript’s ProBio is not only advancing the fight against cancer but also redefining the role of CDMOs in the pharmaceutical value chain. This achievement is a testament to the power of innovation and partnership in shaping the future of healthcare. Author BioFocus Newsroom Previous Next

$8B acquisition brings late-stage bispecific antibody petosemtamab into Genmab’s pipeline, accelerating shift to a wholly owned model with potential blockbuster launches by 2027. < Back Genmab to Acquire Merus in $8B Deal, Adding Breakthrough Oncology Asset to Late-Stage Pipeline $8B acquisition brings late-stage bispecific antibody petosemtamab into Genmab’s pipeline, accelerating shift to a wholly owned model with potential blockbuster launches by 2027. Genmab A/S (Nasdaq: GMAB) has announced plans to acquire Merus N.V. (Nasdaq: MRUS) in an all-cash transaction valued at approximately $8.0 billion, marking a major step in Genmab’s evolution toward a fully owned, late-stage pipeline model. Under the agreement, Genmab will acquire all outstanding shares of Merus for $97.00 per share, a 41% premium over Merus’ September 26 closing price. The deal, unanimously approved by both companies’ boards, is expected to close in early Q1 2026 pending customary conditions, including a minimum 80% tender of shares. Strategic fit: strengthening Genmab’s late-stage pipeline The acquisition brings Merus’ petosemtamab, an EGFRxLGR5 bispecific antibody currently in Phase 3 trials for head and neck cancer, into Genmab’s portfolio. The asset has already received two Breakthrough Therapy Designations from the FDA and showed promising Phase 2 data at ASCO 2025, with both response rates and median progression-free survival outperforming standard of care. Genmab expects petosemtamab to launch as early as 2027, subject to trial outcomes and regulatory approvals, with blockbuster potential and a forecast of at least $1 billion in annual sales by 2029. The company also plans to expand development into earlier lines of therapy and additional indications. “This acquisition clearly aligns with our long-term strategy,” said Jan van de Winkel, Ph.D., President and CEO of Genmab. “Petosemtamab has the potential to be a transformational therapy for patients living with head and neck cancer. With our proven track record in clinical development and commercialization, we are confident we can unlock its promise while accelerating Genmab’s evolution into a global biotechnology leader.” Bill Lundberg, M.D., President and CEO of Merus, added: “Genmab has the right vision and experience to advance petosemtamab in recurrent and metastatic head and neck cancer and beyond. I’m proud of the Merus team for pioneering our Multiclonics® platform and advancing a product candidate with the potential to make a real difference for patients.” Financial details and outlook The acquisition will be funded through a mix of cash on hand and approximately $5.5 billion in non-convertible debt financing underwritten by Morgan Stanley. Genmab expects the transaction to be EBITDA accretive by 2029, while maintaining its target to deleverage to under 3x gross leverage within two years of closing. The transaction does not affect Genmab’s FY2025 guidance, with an updated 2026 outlook to be shared alongside year-end results in February 2026. Industry impact The deal underscores a broader industry trend of biopharma companies seeking to consolidate late-stage oncology assets with strong commercial potential. For Genmab, best known for its antibody expertise and collaborative business model, the acquisition of Merus signals a decisive pivot toward a wholly owned portfolio, with four proprietary programs on track to support multiple launches by 2027. Author BioFocus Newsroom Previous Next

AstraZeneca announces acquisition of EsoBiotec for $1 billion, aiming to advance its cell therapy capabilities with EsoBiotec's in vivo genetic programming platform for cancer and immune-mediated diseases. < Back AstraZeneca to Acquire EsoBiotec in $1B Deal to Drive Next-Generation Cell Therapy AstraZeneca announces acquisition of EsoBiotec for $1 billion, aiming to advance its cell therapy capabilities with EsoBiotec's in vivo genetic programming platform for cancer and immune-mediated diseases. AstraZeneca (LSE/STO/Nasdaq: AZN) has announced the acquisition of EsoBiotec, a leader in pioneering in vivo cell therapies. The acquisition centers around EsoBiotec’s innovative Engineered NanoBody Lentiviral (ENaBL) platform, which offers a transformative approach to cancer treatment and immune-mediated diseases. EsoBiotec's cutting-edge technology delivers genetic instructions directly to immune cells like T cells using targeted lentiviruses, enabling rapid, on-site programming without the need for cell removal and extended processing. This method can deliver cell therapies in a matter of minutes through a simple IV injection—reducing the complexities and timelines associated with traditional treatments that can take weeks. AstraZeneca’s Executive Vice President of Oncology Haematology R&D, Susan Galbraith, expressed her enthusiasm, stating, “We are excited to advance EsoBiotec’s promising in vivo platform, which has the potential to transform cell therapy and enable greater patient access globally.” The deal, valued at up to $1 billion, includes an initial payment of $425 million and additional contingent payments based on development and regulatory milestones. The acquisition will bolster AstraZeneca's cell therapy portfolio, aligning with the company’s mission to expand access to transformative therapies worldwide. With operations based in Belgium, EsoBiotec will operate as a wholly owned subsidiary of AstraZeneca. The acquisition is expected to close in the second quarter of 2025, pending regulatory approvals. Author BioFocus Newsroom Previous Next

What do Protein Evolution, Stella McCartney and Sustainability have in common? We explore how Protein Evolution is shaping a circular economy for plastics and fashion. < Back Protein Evolution: Revolutionizing Recycling with Biotechnology What do Protein Evolution, Stella McCartney and Sustainability have in common? We explore how Protein Evolution is shaping a circular economy for plastics and fashion. Protein Evolution is an innovative biotechnology company that is transforming the recycling industry with its breakthrough Biopure™ technology. The company’s mission is to reduce plastic waste and fossil fuel consumption by creating infinitely recyclable polyester materials. Protein Evolution’s process uses waste-derived precursors to replace petroleum-based ones, revolutionizing traditional recycling methods and offering a sustainable alternative to linear production cycles. Founded in 2021 by Connor Lynn and Jonathan Rothberg, Ph.D., Protein Evolution is committed to advancing circular economy solutions for industries heavily reliant on plastic materials. Its technology aims to create new materials that can be infinitely recycled, thus reducing the environmental impact of plastic production and waste. Innovative Partnerships and Impact Protein Evolution’s impact extends beyond just technological innovation—it has formed strategic collaborations with influential players in both the fashion and sustainability sectors. One notable partnership is with the iconic fashion brand Stella McCartney, where Protein Evolution’s technology has been employed to produce garments using 100% recycled fibers. Together, Protein Evolution and Stella McCartney crafted the world’s first garments from this novel material, introduced at The 2023 United Nations Climate Change Conference or Conference of the Parties of the UNFCCC, more commonly known as COP28. Protein Evolution is also supported by the SOS Fund , a $200 million investment fund, co-founded by Stella McCartney, that is designed to support and empower the next generation of innovators. This collaboration underscores the growing demand for sustainable practices in the fashion industry and highlights Protein Evolution’s role in shaping future material supply chains. The company’s commitment to sustainability is also evident in its partnerships with research institutions and other biotechnology innovators, including Basecamp Research. You can read more about the work Basecamp Research is doing in our article . These collaborations further propel the development of new recycling technologies and sustainable materials that are crucial for mitigating the ongoing plastic pollution crisis. Driving Change in Plastic and Textile Industries In addition to its work in fashion, Protein Evolution is positioning itself as a key player in the broader plastics industry. The company’s innovations have the potential to transform how industries across the globe approach waste management and material recycling. By making plastic production more sustainable, Protein Evolution is contributing to the reduction of carbon footprints and helping companies transition to a more sustainable business model. The company’s efforts go beyond just producing recyclable materials—they are working to create a new, more sustainable approach to plastic and textile production. Their technology is poised to be a game changer, offering new possibilities for closed-loop recycling systems across various sectors. Looking to the Future Protein Evolution’s journey is just beginning, but the impact of its technology is already significant. With a team of experts, a growing number of high-profile partnerships, and ongoing research, the company is paving the way for a future where plastics and textiles are no longer a source of pollution but an integral part of a sustainable, circular economy. As Protein Evolution continues to expand its reach and refine its technology, the company is set to play a leading role in the future of industrial biotechnology. With its mission to decarbonize plastic production and create infinitely recyclable materials, Protein Evolution is not just advancing a scientific innovation—it is shaping the future of sustainable materials on a global scale. For more information about Protein Evolution’s mission, technology, and partnerships, visit their website . Author BioFocus Newsroom Previous Next

IGM Biosciences is discontinuing its lead autoimmune programs, imvotamab and IGM-2644, following disappointing clinical results, and implementing a 73% workforce reduction while reevaluating its strategic direction. < Back IGM Biosciences Halts Lead Autoimmune Programs, Cuts Workforce by 73% IGM Biosciences is discontinuing its lead autoimmune programs, imvotamab and IGM-2644, following disappointing clinical results, and implementing a 73% workforce reduction while reevaluating its strategic direction. IGM Biosciences , a clinical-stage biotechnology company, has announced a major shift in its strategic direction, discontinuing its lead autoimmune programs and implementing significant workforce reductions. The company cited disappointing interim results from clinical studies as the primary reason behind its decision. Key Programs Discontinued The company’s lead program, imvotamab, a CD20 x CD3 bispecific IgM antibody, was being developed to treat rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Phase 1b trials revealed inconsistent and insufficient B cell depletion, a critical mechanism for the treatment of these autoimmune conditions. The company also discontinued its IGM-2644 program, a targeted effort to develop therapies for autoimmune and inflammatory diseases. Workforce and Financial Impact In response to these developments, IGM Biosciences announced a 73% workforce reduction, affecting approximately 144 employees. This restructuring is intended to conserve resources as the company re-evaluates its strategy. As of December 31, 2024, IGM reported $183.8 million in cash and investments, which will support the transition. Strategic Reevaluation Underway Dr. Mary Beth Harler, CEO of IGM Biosciences, expressed gratitude to the patients, investigators, and employees who contributed to the discontinued programs. She acknowledged the difficult but necessary decision to halt these projects and emphasized the company’s commitment to identifying new pathways to address unmet medical needs. IGM is now focused on assessing internal opportunities and exploring potential strategic alternatives to maximize shareholder value. Industry Implications The decision reflects the challenges of translating innovative therapeutic approaches into consistent clinical success. Analysts suggest that the company’s focus on IgM antibody technology, though promising, has struggled to deliver the required efficacy in autoimmune indications. Looking Forward While the discontinuation of these programs marks a setback, IGM’s proprietary IgM platform remains a potential asset for addressing other medical conditions. The company is expected to provide further updates as it refines its strategic priorities. This announcement follows a broader industry trend of biotech firms reassessing pipelines and conserving cash amid uncertain economic conditions and rising development costs. Author BioFocus Newsroom Previous Next

We sit down with Sepmag's Lluís M. Martinez, Founder & CSO, and Josep-Maria Simó, Managing Director, to discuss the current state and future of magnetic separation technology. < Back Magnetic Bead Separation: More Than Just a Magnet We sit down with Sepmag's Lluís M. Martinez, Founder & CSO, and Josep-Maria Simó, Managing Director, to discuss the current state and future of magnetic separation technology. Magnetic bead separation has become a cornerstone technique in life science research and industrial applications, enabling the isolation of proteins, nucleic acids, cells, and other biomolecules with high specificity and efficiency. Despite its widespread adoption, many researchers encounter inconsistent results, leading to frustration and inefficiencies. The root cause of these inconsistencies often lies in an incomplete understanding of the three equally critical components required for effective magnetic bead separation: The magnetic bead The ligand The magnetic bead separator To guide us to success with magnetic bead separation, we spoke with Lluís M. Martinez, Founder & CSO, and Josep-Maria Simó, Managing Director, at Barcelona-based Sepmag , to understand the challenges of traditional approaches, and how advancements in magnetic separation technology are revolutionizing the field. Applications for Life Science Research The benefits of advanced magnetic separation technology extend across a wide range of applications, aimed at improving efficiency, reproducibility, and scalability. Cell Isolation Magnetic bead separation is widely used to isolate specific cell populations from complex mixtures, such as blood or tissue samples. In immunotherapy research, scientists isolate CD4+ or CD8+ T cells from patient blood samples to study immune responses or develop CAR-T cell therapies. Protein Purification Optimized magnetic separation enables higher purity and recovery rates of target proteins, a critical step in drug development and biochemical research. For example, in biopharmaceutical production, researchers use magnetic beads coated with antibodies to isolate monoclonal antibodies (mAbs) from cell culture supernatants. Nucleic Acid Extraction Advanced magnetic separation systems enable efficient isolation of DNA and RNA, ensuring high yield and purity even from complex clinical samples. In liquid biopsy testing, circulating tumor DNA (ctDNA) and RNA are extracted from patient blood samples to detect cancer-related mutations. Because these nucleic acids are often present in very low concentrations, a constant magnetic force ensures consistent separation, minimising loss and maximising sensitivity. Diagnostics Consistent and reproducible separations are essential for diagnostic assays, where precision and reliability directly impact patient outcomes. Magnetic bead-based immunoassays are widely used in point-of-care testing for infectious diseases such as HIV, tuberculosis, and COVID-19. However, in order for magnetic bead separation to be effective across these applications—and many more—scientists must truly understand how the separation process works in order to maximise the efficiency and effectiveness of their research. The Three Pillars of Magnetic Bead Separation 1. The Magnetic Bead: The Foundation of the Process Magnetic beads are the workhorses of separation protocols. Typically composed of superparamagnetic materials, beads exhibit strong magnetic responsiveness in the presence of a magnetic field. Importantly, they retain no residual magnetism once the field is removed—allowing the magnetic beads to move when a magnetic force is applied, and enable resuspension when no magnetic field is present. However, not all magnetic bead suspensions are equal. The size, surface chemistry, and magnetic properties of the beads can significantly impact separation efficiency. Additionally, the bead concentration and buffer composition also play a critical role. For instance, smaller beads may offer higher surface area for ligand binding but require longer separation times due to slower migration. Conversely, larger beads may separate faster, but risk aggregation if the magnetic force is too strong. Reducing the bead concentration implies a larger separation time, and the buffer composition will also have a significant influence. The separation process is a competition between magnetic and drag force, where viscosity (directly related to temperature) plays a major role, as does the ionicity of the medium. 2. The Ligand: Ensuring Specificity and Binding Efficiency The ligand is the molecule attached to the magnetic bead that confers specificity to the separation process. Whether it’s an antibody, nucleic acid probe, or affinity tag, the ligand must exhibit high affinity and specificity for the target molecule, with a well-designed ligand ensuring that the target is efficiently captured, while minimizing non-specific binding. However, even the most perfect ligand can fail if it is not properly conjugated to the magnetic bead. Inconsistent conjugation can lead to uneven binding capacity, reducing the overall yield and reproducibility of the separation. The ligand’s performance can be influenced by buffer composition, pH, and temperature, further demanding the need for careful optimization. The separation process must also balance separation times and retention forces to avoid bead loss or irreversible aggregation, both of which are known to introduce inconsistencies during the conjugation process. 3. The Magnetic Bead Separator: The Tool That Makes It All Work The magnetic bead separator is often the most overlooked component of the separation process, yet it plays a pivotal role in determining the success of the protocol. Failure in determining the right separation time results in the loss of magnetic beads: weak magnetic retention forces may also lead to the beads being carried away when the supernatant is removed, whilst excessive magnetic force may generate clumps of beads and/or damage the captured cells. Traditional separators, such as simple permanent magnets, generate irregular magnetic fields where the force varies significantly with distance from the magnet with this variability leading to inconsistent bead migration. Beads near the magnet are captured quickly and retained with strong magnetic force, while those farther away move more slowly because the force they experience is very weak. Over even relatively short distances, the magnetic force may fail to overcome the thermal agitation and the drag force, completely preventing the capture of the beads. As a result, many users discard using magnetic separation for processing involving larger volumes. When working with smaller volumes, users often rely on subjective, time-based protocols that fail to account for changes in bead concentration, buffer viscosity, or vessel geometry, leading to inconsistent protocols when the magnet or the vessel is changed. Feature Traditional Separators Smart Magnetic Bead Separators Magnetic Force Distribution Irregular, weakens with distance Constant across the separation area Bead Migration Inconsistent; beads near the magnet move faster, while others may not move at all Uniform movement for all beads Volume Handling Struggles with larger volumes; inefficient capture Works consistently across different volumes Protocol Reproducibility Time-based, inconsistent when vessel or conditions change Transferable by adjusting separation time Real-Time Monitoring Not available Measures opacity changes for precise separation timing Buffer Composition Sensitivity Low; variations often unnoticed High; allows quantification of buffer effects Lot-to-Lot Consistency Difficult to monitor Detects variations via time-dependent opacity changes Table 1: Comparison of traditional magnetic separators vs smart magnetic bead separators. Smart magnetic bead separators address these challenges by focusing on the key parameter of the process: generating a constant magnetic force across the entire separation area. This ensures that all beads experience the same force, regardless of their position in the vessel, leading to more predictable and reproducible separations. A constant magnetic force implies all the beads in a specific suspension will move at the same speed, regardless of the volume. Protocols can be transferred to different vessels simply by adjusting the separation time to account for the length of the path travelled by the farthest magnetic beads. Additionally, smart systems incorporate real-time monitoring capabilities. Changes to the opacity of the suspension allow for the objective and precise determination of the separation time for any suspension and vessel—as magnetic beads move at the same speed under constant magnetic force, any variations in buffer composition become highly detectable. This enables researchers to quantify the impact of changes in magnetic beads and buffers on the magnetic separation process, giving manufacturers a powerful tool to check the lot-to-lot consistency, and serving as an early alert for changes in the suspension. Smart Magnetic Bead Separation Technology The last 20 years of development in magnetic bead separation technology have addressed many of the limitations of traditional methods, allowing users to adopt a well-controlled process at any volume; from microliter well-plates to tens of liters in carboys and bioreactors. At Sepmag, we encourage our clients to focus on the following three key principles, and have seen firsthand how smart magnetic bead systems have transformed the way researchers approach magnetic bead separation: Constant Magnetic Force : Uniform magnetic force across the separation area ensures that all beads migrate at the same speed, reducing the risk of aggregation and improving reproducibility. Real-Time Monitoring : Optical monitoring allows users to track the separation process in real time, generating separation curves that provide objective data on bead migration kinetics, calculates separation times and provides detailed information about the magnetic bead suspension composition. Process Standardization : Defining separation protocols in terms of magnetic force rather than time enables the development of universal methods that can be applied across different scales and applications. For a given magnetic bead suspension, a specific magnetic force determines a separation speed which predicts the separation times of different volumes to facilitate the planning of experiments and procedures in advance. Enhancing Separation with Sepmag As life science research continues to advance, the demand for precise, reproducible, and scalable separation methods will only grow. Recent innovations in magnetic separation technology have made a significant step forward to meet demands across scientific discovery and industrial applications. At Sepmag, we provide solutions across small scale, large scale and customised magnetic separation. Our technology provides monitoring and measuring in real time, can be fully automated, and works with magnetic beads from all the major manufacturers. If you would like to learn more about magnetic separation technology, and how it can progress your research and processing challenges, reach out to Lluís M. Martinez and Josep-Maria Simó or visit the Sepmag website . Author BioFocus Newsroom Previous Next

Universities help commercialize life science research by turning discoveries into market-ready innovations through patents, spin-offs, and industry partnerships. < Back The Role of Universities in Commercializing Life Science Research Universities help commercialize life science research by turning discoveries into market-ready innovations through patents, spin-offs, and industry partnerships. Did you know that CRISPR technology , one of the most transformative breakthroughs in genetic engineering, was born in a university lab? What started as a quest to understand bacterial immune systems evolved into a revolutionary tool for precise DNA editing. This journey from academic curiosity to a world-changing application underscores the pivotal role of universities in advancing life sciences research. Universities serve as hotbeds of innovation, nurturing ideas that push the boundaries of knowledge. Beyond discovery, these institutions bridge the gap between fundamental research and practical application, ensuring groundbreaking insights become transformative technologies. By fostering partnerships, patenting discoveries, and supporting startups, universities amplify their impact, shaping industries and improving lives. This article looks into the commercialization of life sciences research within universities, exploring the pathways from lab to market, the success stories that inspire innovation, and the challenges that require creative solutions. The Importance of Academic Research in Life Sciences Catalysts for Innovation Academic research is the foundation of breakthroughs in life sciences , driving advancements in healthcare, biotechnology, and diagnostics. Universities foster curiosity-driven research that lays the groundwork for transformative technologies: CRISPR-Cas9 Gene Editing : Initially discovered through studies of bacterial immune systems, this tool has revolutionized genetics, enabling unprecedented precision in DNA modification. DNA double helix : The iconic discovery by Watson and Crick formed the basis for modern molecular biology and biotechnology. Such discoveries often take decades to mature into practical applications. On average, 17 years elapse from initial research to commercialization, yet the long-term rewards are substantial. Transforming Healthcare University research drives critical advancements in medicine, such as: New treatments and vaccines : The Oxford/AstraZeneca COVID-19 vaccine, developed in record time , is a prime example of university-industry collaboration saving millions of lives. Diagnostics : Innovations like liquid biopsies enable early detection and monitoring of diseases, reshaping healthcare paradigms. Biotechnology products : Bioengineered foods enriched with essential nutrients address global nutritional challenges, showcasing the broad impact of academic research. The commercialization process Bridging academia and industry Technology Transfer Offices (TTOs) are pivotal in transforming research into market-ready innovations. Established at most research-focused universities, TTOs ensure discoveries transcend academic journals to benefit society. Core functions of TTOs: Patenting : TTOs guide researchers in securing intellectual property rights, ensuring discoveries are protected and commercially viable. Market research : By evaluating market potential, TTOs align innovations with industry needs. Licensing : TTOs negotiate agreements, granting companies the rights to develop and market university-owned technologies. Spin-off support : TTOs assist in forming new companies to commercialize research when direct licensing isn't feasible. Networking : Connecting researchers with industry experts and investors expands the ecosystem necessary for innovation. Funding : Many TTOs provide seed funding , addressing the critical "valley of death" where early-stage projects often stall. Patents and licensing Patents are the cornerstone of research commercialization, protecting novel inventions and making them attractive to investors. The Bayh Dole Act of 1980 transformed this landscape by allowing universities to retain ownership of federally funded research. Since its enactment: University-filed patents increased substantially between 1980 and 2009. Licensing revenues have fueled further research and development. Spin-offs and startups based on patented technologies have flourished, exemplified by advancements like CRISPR-Cas9 and mRNA vaccines. Spin-Off Companies When licensing isn’t viable, universities often foster spin-offs—new companies dedicated to commercializing academic discoveries. There are several key steps in spin off creation: Identifying opportunities : Researchers and TTOs assess the commercial potential of discoveries. Building a business case : This involves crafting a strategy, identifying funding sources, and securing stakeholder buy-in. Securing IP : Robust intellectual property protections form the foundation for successful commercialization. Launching the company : Spin-offs often start in university incubators, benefiting from mentorship and initial funding. Examples of Success: Genentech : A pioneer in recombinant DNA technology, Genentech’s university roots catalyzed the biotech industry. Moderna : Founded on mRNA research , Moderna’s COVID-19 vaccine is a testament to the transformative power of university-led innovation. Challenges and Opportunities Addressing the "Valley of Death" Funding gaps between research and commercialization—known as the " valley of death "—pose significant barriers. Proposed solutions include: Proof-of-Concept Grants : Targeted funding to support early-stage projects. University Venture Funds : Internal funding mechanisms to de-risk innovations. Bridging cultural and skill gaps Diverging priorities between academia (publishing) and industry (profitability) can hinder partnerships. Solutions include: Entrepreneurial training : Programs such as NSF Innovation Corps train researchers in business fundamentals. Collaborative networks : Formalized university-industry partnerships ensure alignment of goals. Navigating regulatory complexities Compliance with stringent regulations requires expertise and resources. Universities can address this by engaging regulatory consultants and creating in-house teams to guide commercialization efforts. Conclusion Universities are vital engines of innovation in the life sciences, transforming foundational research into real-world applications that improve lives and drive economic growth. Despite challenges, strategic initiatives like enhanced TTOs, targeted funding, and strengthened industry partnerships are paving the way for more efficient commercialization. By fostering environments where academic discoveries thrive, universities will continue to be at the forefront of life sciences innovation, shaping a healthier and more sustainable future for all. Author Ramya Nadig , freelance contributor Previous Next

AI-powered 3D lung imaging to accelerate assessment of CAL101, a first-in-class antibody targeting a key driver of fibrosis. < Back Qureight AI to Power Calluna’s Phase 2 IPF Study AI-powered 3D lung imaging to accelerate assessment of CAL101, a first-in-class antibody targeting a key driver of fibrosis. Qureight, a leading techbio company transforming clinical imaging through AI, today announced it will provide its advanced 3D imaging platform to support Calluna Pharma’s Phase 2 AURORA trial of CAL101, a novel investigational therapy for idiopathic pulmonary fibrosis (IPF). The partnership brings together cutting-edge imaging analytics and innovative drug development to tackle one of the most challenging and life-limiting lung diseases. IPF is a progressive and currently incurable condition with limited treatment options. CAL101, Calluna’s lead monoclonal antibody, targets S100A4, a protein that acts as an upstream amplifier of multiple pro-fibrotic pathways involved in IPF. Qureight’s platform will be used throughout the trial to deliver high-resolution, quantitative assessments of lung anatomy, including fibrosis volume and other imaging biomarkers. These insights will inform both patient selection and ongoing efficacy evaluation. “Calluna’s decision to work with us on this pivotal trial reflects the power of our AI platform to deliver real-time, clinically meaningful data,” said Steven Bishop, Chief Data Officer at Qureight. “IPF is a disease where time matters, for both patients and drug developers. Our technology enables faster, more precise evaluation of how new therapies impact lung structure, helping accelerate progress in this high-need area.” The AURORA study is a randomised, double-blind, placebo-controlled trial enrolling 150 IPF patients across more than 50 global sites in the US, UK, EU, Turkey, and South Korea. Participants will receive seven monthly infusions of CAL101 or placebo, with forced vital capacity (FVC), a key measure of lung function, serving as the primary endpoint. Qureight’s AI tools will allow researchers to detect subtle changes in lung fibrosis that are often missed by conventional image interpretation. Unlike traditional methods, which are manual, slow, and susceptible to human variability, Qureight’s platform delivers standardised, high-fidelity results that can be acted on quickly. “Dosing the first patient in AURORA marked a major milestone for Calluna and our mission to transform outcomes for people living with IPF,” said Dr. Jonas Hallén, Co-Founder and Chief Medical Officer at Calluna Pharma. “Qureight’s imaging technology is an integral part of the study, giving us critical, data-driven insight into how CAL101 may halt or slow lung function decline.” The collaboration underscores a growing trend in clinical research: integrating AI and digital health tools to de-risk development and accelerate timelines. Qureight’s role in AURORA highlights how advanced imaging analytics can enhance both the scientific rigor and efficiency of trials in complex diseases like IPF. About Qureight Qureight is a Cambridge-based techbio company using AI and cloud-based platforms to curate, analyze, and interpret imaging and clinical data in complex lung and heart diseases. Its technology enables real-time insights to support faster, more accurate clinical decision-making and drug development. About Calluna Pharma Calluna Pharma is a clinical-stage biopharmaceutical company developing novel therapies for fibrotic and inflammatory diseases. Its lead candidate, CAL101, is a first-in-class monoclonal antibody targeting S100A4, a key molecular driver of fibrosis. Author BioFocus Newsroom Previous Next

SpliceBio has raised €130M in Series B funding to advance its gene therapy for Stargardt disease and expand its pipeline using a proprietary protein splicing platform. < Back SpliceBio Raises €130M Series B to Advance Stargardt Gene Therapy and Expand Genetic Medicines SpliceBio has raised €130M in Series B funding to advance its gene therapy for Stargardt disease and expand its pipeline using a proprietary protein splicing platform. Barcelona-based biotech SpliceBio has secured €130 million in Series B financing to accelerate the development of its lead gene therapy candidate for Stargardt disease and expand its pipeline of genetic medicines. The raise marks a major milestone for the company’s proprietary protein splicing platform, which is designed to overcome key limitations in gene delivery. The round was co-led by Forbion and UCB Ventures, with participation from a strong syndicate of new and existing investors including Andera Partners, EQT Life Sciences, Invivo Capital, Ysios Capital, Kurma Partners, and the European Innovation Council (EIC) Fund. The funding will primarily support the advancement of SB-007, SpliceBio’s lead program targeting Stargardt disease, a debilitating inherited retinal disorder caused by mutations in the ABCA4 gene. Because of the gene’s large size, it has long been out of reach for conventional AAV-based gene therapies. SpliceBio’s technology provides a way to address this challenge and meet a significant unmet medical need. “Our protein splicing platform opens the door to treating diseases that have been out of reach for traditional gene therapy,” said Miquel Vila-Perelló, CEO and co-founder of SpliceBio. “With this financing, we’re taking a significant step toward bringing SB-007 into the clinic and expanding our pipeline into other indications where large genes have been a limiting factor.” SpliceBio’s proprietary Protein Splicing technology allows for the reassembly of large functional proteins from smaller gene fragments delivered via standard AAV vectors. This approach could significantly expand the range of diseases that gene therapy can effectively address, particularly those involving mutations in oversized genes that cannot be packaged into a single vector. In addition to advancing SB-007 into clinical development, the Series B funding will support internal manufacturing capabilities and accelerate the company’s discovery programs in both ocular and systemic genetic diseases. As gene therapy continues to evolve, safe and efficient delivery remains one of the field’s biggest challenges. With its innovative platform and strong investor backing, SpliceBio is positioning itself as a leader in the next generation of genetic medicines, aiming to deliver transformative therapies where existing approaches have yet to succeed. Author BioFocus Newsroom Previous Next

New review highlights the environmental impact of AI in healthcare and urges for sustainable practices < Back Sustainable Artificial Intelligence in Healthcare Amidst Climate Change New review highlights the environmental impact of AI in healthcare and urges for sustainable practices Introduction Climate change poses significant challenges to various sectors, including healthcare, which is responsible for a substantial portion of global greenhouse gas emissions. Artificial Intelligence (AI), particularly in radiology, has revolutionized diagnostic and therapeutic practices but raises concerns about its environmental impact. Researchers at Osaka Metropolitan University have conducted an investigation of the environmental costs of AI within the medical field, examining the intersection of climate change and AI in healthcare, focusing on both the environmental burdens and potential solutions for mitigating these impacts. Their review emphasizes the dual nature of AI’s role in modern medicine—both as a transformative tool and a contributor to environmental challenges. Environmental Costs of AI AI systems, especially those utilizing deep learning, require considerable computational resources and energy, which contribute to the carbon footprint of healthcare. Training large AI models can emit as much CO₂ as five cars over their lifetimes. Data centers, essential for AI infrastructure, further exacerbate this issue due to their high energy consumption, often sourced from non-renewable methods. Additionally, the rapid turnover of hardware generates significant electronic waste (e-waste) and depletes natural resources. The indirect environmental effects of AI, such as habitat destruction from mining rare earth elements, also need consideration. Mitigation Strategies Several strategies can mitigate the environmental impact of AI in healthcare: Energy-efficient AI Models : Techniques like model compression, quantization, and pruning can reduce energy consumption during AI training and deployment. Green Computing Practices : Adopting energy-efficient hardware, optimizing software, and integrating renewable energy sources into data centers can lower carbon footprints. Lifecycle Assessments : Evaluating the environmental impact of AI systems throughout their lifecycle helps in making sustainable design and disposal decisions. AI's Role Beyond Sustainability AI not only has an environmental impact but can also offer solutions to reduce the healthcare sector’s carbon footprint: Workflow Optimization : AI can streamline radiological workflows, reduce unnecessary imaging, and enhance resource utilization. Telemedicine : AI can facilitate remote consultations , reducing the need for patient travel and associated emissions. Emerging Technologies : Innovations like nuclear fusion , with AI's help, could provide sustainable energy sources, further reducing reliance on fossil fuels. Policy and Governance Effective policy and governance are crucial for managing AI's environmental impact: Regulatory Frameworks : Policymakers need to develop regulations that address the lifecycle impact of AI, including energy efficiency and e-waste management. Global Initiatives : International efforts, such as the WHO's Digital Health Initiative and ITU's "AI for Good" are vital for promoting sustainable AI practices. Collaborative Research : Platforms like the Green AI Consortium facilitate knowledge sharing and innovation in sustainable AI. Best Practices for Sustainable AI To promote sustainability in AI deployment, best practices include: Eco-Design : Designing AI systems with lifecycle assessments to minimize environmental impact. Energy Efficiency : Developing models and infrastructure that reduce energy consumption. Responsible Data Management : Implementing efficient data storage and processing practices. Collaborative Efforts : Encouraging joint research and sharing of sustainable practices. Continuous Improvement : Monitoring and refining sustainability measures regularly. Sustainable Procurement and Disposal : Prioritizing eco-friendly hardware and responsible e-waste disposal. Education and Awareness : Raising awareness about the environmental impacts and best practices for sustainable AI. Conclusion The convergence of AI and climate change in healthcare presents both challenges and opportunities. By prioritizing sustainable practices, the healthcare industry can harness AI's transformative potential while mitigating its environmental impact. Radiologists and other healthcare professionals have a critical role in leading by example, advocating for energy-efficient AI algorithms, and integrating environmental considerations into AI deployment. Embracing sustainability in AI will help drive positive change, ensuring that advancements in healthcare contribute to both improved patient outcomes and environmental stewardship. Continuous dialogue among stakeholders is essential for aligning AI development with broader sustainability goals, aiming for a future where technology benefits both human health and the planet. Author BioFocus Newsroom Previous Next

Explore how eDNA analysis transforms wildlife monitoring, aiding in the detection of invasive species and safeguarding ecosystem health. < Back Unveiling Biodiversity: The Power of eDNA Analysis Explore how eDNA analysis transforms wildlife monitoring, aiding in the detection of invasive species and safeguarding ecosystem health. Why is measuring biodiversity important? Nature provides us with ‘ecosystem services’ (e.g., clean water, raw materials, carbon sequestration) which underpin healthy societies and economies. Biodiversity, which drives ecosystem function and resilience, is inherent to deriving these ecosystem benefits. There is an estimated USD $700 billion funding gap for nature restoration. The development of biodiversity credits, alongside blue bonds and carbon credits, could be a potential financial tool to monetise the recovery of ecosystems. It is therefore essential that we are able to measure biodiversity with a certain degree of confidence, so Environmentalists, Scientists and Policymakers can understand how populations are changing over time and between habitats. But how can we measure biodiversity? Until recently, measuring biodiversity would mean physically looking for flora and fauna and recording direct observations. This could involve visual surveys, trawls, seines and tissue biopsies. As well as being costly, time-consuming and invasive, these methods have obvious flaws when considering cryptic, rare or elusive species. Similarly, smaller organisms can be hard to identify in the field. So how can we measure what we cannot see? What is eDNA? Fortunately, as organisms move around their environment they are constantly shedding bits of themselves, in the form of dead skin cells, mucus and faeces. All of this organic matter contains DNA, known as environmental DNA (eDNA). Water, air, soil and sediment samples can be tested for the presence of eDNA, which indicates the recent presence of an organism in that environment, even if that organism has never been directly observed. This can be particularly significant if IUCN Red List species are captured in the samples, indicating the presence of threatened species. It can also notify the presence of invasive species, which are damaging to the ecosystem and commonly result in a loss of native biodiversity. Thus, eDNA analysis has allowed researchers to generate a much more robust and holistic picture of true biodiversity within an ecosystem, while also causing less environmental disturbance. Figure 1. The benefits of eDNA as a tool to measure biodiversity (NatureMetrics, 2024) Limitations of eDNA eDNA has never been well characterised and does have its limitations as a tool. It can allow us to gather information on the presence or absence of a target species, but is unable to provide any information on factors such as species life stage, reproduction or fitness. However, DNA-based methods complement—rather than replace—traditional surveys. Methodologies such as bioacoustics, satellites, cameras and LiDAR can be used in tandem with eDNA to broaden and deepen the evidence base. Conclusion eDNA has the potential to make significant contributions to the detection of invasive species, community and ecosystem biodiversity, functional diversity, wildlife, and conservation biology. As technology and ideas for the use of eDNA continue to develop, eDNA has the potential to continue opening up innovative and creative ways to study and help to protect the wildlife around us. Author Francesca Read Cutting , freelance contributor Previous Next