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Aim higher to reach new peaks. Preparing your cell culture workflow to scale for success. As workflows scale up toward clinical and commercial production volumes, failures or unexpected outcomes can result in costly delays for biologics developers. This article shares how to proactively consider factors such as the medium and feed system, the manufacturing workflow, and the choice of supplier, to help reduce the risk of delays, mitigate unforeseen costs, and rapidly deliver the needed therapeutic to patients. Learn more on how you can aim higher, reach new peaks, and scale your processes with confidence, download now. First name Last name Country Email Institution City Would you like to have a Thermo Fisher Scientific bioprocessing specialist contact you for a quote, demo, sample, or to provide technical support? Choose an option I acknowledge and agree to the use of my contact information to receive messages about offerings by BioFocus, its brands, affiliates and/or third-party partners, consistent with the BioFocus Privacy Policy Read article

Agreement enhances Lonza’s bioprocessing and QC solutions with validated four-day sterility testing. < Back Lonza Strengthens Rapid Microbiology Portfolio With Planned Acquisition of Redberry Agreement enhances Lonza’s bioprocessing and QC solutions with validated four-day sterility testing. Lonza has announced that it has signed an agreement to acquire Redberry SAS, a company known for its rapid microbiology testing solutions powered by solid-phase cytometry (SPC). The move will expand Lonza’s bioscience testing capabilities and add the Red One system, a platform designed for rapid sterility and bioburden testing, to its growing suite of automated pharmaceutical quality control tools. Redberry has established itself as a leader in SPC technology, offering highly sensitive and precise microbial detection solutions for the pharmaceutical sector. Its Red One platform is engineered to meet the industry’s increasing need for speed and simplicity in microbiological testing. The system delivers rapid sterility and bioburden results, with strong potential to streamline QC workflows. In April 2025, Redberry announced the successful validation of its Red One rapid sterility testing method, which can generate results in just four days. Traditional sterility testing typically requires a minimum incubation period of 14 days, making Redberry’s approach a notable advancement for manufacturers seeking faster product release without compromising safety or compliance. Lonza already provides a wide portfolio of QC testing services, including industry-leading endotoxin detection. The acquisition will integrate Redberry’s rapid detection technology into Lonza’s global offering, helping customers bring products to market more quickly while maintaining rigorous quality standards, especially in biologics and cell and gene therapy manufacturing. Mike Goetter, Head of Bioscience, Specialized Modalities at Lonza, said: “Our agreement to acquire Redberry marks a significant milestone in our commitment to advancing QC microbiology solutions in line with growing industry demand for rapid testing platforms. By integrating this cutting-edge technology into our portfolio, we are empowering customers with faster and simpler tools that lower compliance costs. It will also support scale-up, process, and product integrity for biologics and cell and gene therapy production. It is a strategic step forward in reducing risk, ensuring right first time delivery, and enhancing efficiency across the industry.” Jonathan Macron, CEO of Redberry, said: "Joining Lonza is a natural next step in Redberry’s journey. Since its creation, Redberry has been dedicated to delivering faster, simpler, and reliable microbiological control. By combining Red One™ with Lonza’s global reach and expertise, we will scale our innovation to meet the growing needs of pharmaceutical and industrial manufacturers, accelerate product release and benefit patients worldwide, while together setting a new standard in pharmaceutical quality control." The transaction is expected to close in the fourth quarter of 2025, subject to customary closing conditions, and is not considered financially material to Lonza’s financial guidance. Author BioFocus Newsroom Previous Next

A BioFocus educational piece discussing important considerations when implementig perfusion and traditional bioprocessing workflows. < Back Comparing Perfusion Bioprocessing and Traditional Bioprocessing Methods A BioFocus educational piece discussing important considerations when implementig perfusion and traditional bioprocessing workflows. Bioprocessing is fundamental to the production of biologics, such as vaccines, monoclonal antibodies, and other therapeutic proteins. Traditional bioprocessing methods, including batch and fed-batch processes, have been the industry standard for decades. However, perfusion bioprocessing is gaining attention as a more efficient and productive alternative. This article compares perfusion bioprocessing with traditional methods, highlighting the key differences and advantages of each. Traditional bioprocessing methods Batch bioprocessing In batch bioprocessing, cells are grown in a fixed volume of nutrient medium, and the process runs until the nutrients are depleted or inhibitory waste products accumulate. The product is then harvested at the end of the cycle. Advantages: Simplicity: Easy to set up and manage. Lower initial investment: Requires simpler infrastructure and equipment. Disadvantages: Lower productivity: Limited by the volume of the initial nutrient medium. Variability: Greater batch-to-batch variability in product quality. Downtime: Requires time for setup, sterilization, and cleaning between batches. Fed-Batch bioprocessing Fed-batch bioprocessing improves upon batch processing by periodically adding fresh nutrients to the culture, which extends the growth phase and increases product yield. Advantages: Improved productivity: Extending the growth phase leads to higher product yields. Better control: Allows for more precise control over nutrient levels and growth conditions. Disadvantages: Intermediate complexity: More complex than batch processing. Still limited: While better than batch, it still experiences downtime and variability. Perfusion bioprocessing Perfusion bioprocessing is a continuous culture system where cells are constantly supplied with fresh nutrient medium while waste products and spent medium are simultaneously removed. This creates a steady-state environment conducive to optimal cell growth and consistent product production. Advantages: High Productivity: Continuous operation supports high cell densities, resulting in significantly higher yields. Consistent Product Quality: The steady-state environment minimizes batch-to-batch variability, ensuring consistent product quality. Efficiency: Smaller bioreactors can achieve the same production levels as larger batch systems, reducing costs. Real-Time Control: Advanced monitoring systems enable real-time adjustments to maintain optimal conditions. Scalability: Easily scalable from laboratory to commercial production. Sustainability: More efficient use of resources and reduced waste generation. Disadvantages: Complexity: Requires sophisticated equipment and control systems. Initial Investment: Higher initial capital investment for setup and equipment. Comparison Productivity and Yield Traditional Methods: Limited by the nutrient medium's initial volume and the growth phase's duration. Productivity is inherently lower. Perfusion: Continuous nutrient supply and waste removal support higher cell densities and extended production periods, significantly increasing overall yield. Product Quality Traditional Methods: Batch and fed-batch processes can lead to variability in product quality due to fluctuating growth conditions and nutrient levels. Perfusion: The steady-state environment ensures consistent conditions, leading to more uniform product quality. Operational Efficiency Traditional Methods: Require downtime for cleaning, sterilization, and setup between batches, reducing overall efficiency. Perfusion: Continuous operation eliminates downtime, maximizing bioreactor usage and operational efficiency. Resource Utilization Traditional Methods: Generally involve higher consumption of raw materials and generation of waste due to less efficient use of nutrients. Perfusion: More efficient nutrient use and continuous waste removal reduce raw material consumption and waste production. Scalability Traditional Methods: Scaling up involves larger bioreactors and more complex nutrient management, which can be challenging and costly. Perfusion: Easier to scale, as the process is continuous and can be maintained in smaller, more efficient bioreactors. Cost Implications Traditional Methods: Lower initial setup costs but higher operational costs due to inefficiencies and downtime. Perfusion: Higher initial capital investment but lower operational costs and higher long-term savings due to increased efficiency and productivity. Both traditional and perfusion bioprocessing methods have their respective advantages and disadvantages. Traditional methods offer simplicity and lower initial costs, making them suitable for smaller-scale operations or processes where high yield and consistency are less critical. However, for large-scale production and applications requiring high productivity and consistent product quality, perfusion bioprocessing presents a compelling alternative. As the biotechnology industry continues to evolve, the adoption of perfusion bioprocessing is likely to increase, driven by its superior efficiency, scalability, and sustainability. Author BioFocus Newsroom Previous Next

Collaboration leverages AI-driven predictive modeling to cut AAV stable cell line development timelines by up to 70%, reducing cost and accelerating path to clinic. < Back Cytiva and WhiteLab Genomics Partner to Accelerate AI-Driven Stable Cell Line Development for AAV Collaboration leverages AI-driven predictive modeling to cut AAV stable cell line development timelines by up to 70%, reducing cost and accelerating path to clinic. Stable cell line development has long been a bottleneck in AAV-based genomic medicine manufacturing. A new collaboration between Cytiva and WhiteLab Genomics aims to change that, using artificial intelligence to cut development timelines and costs by as much as 70%. WhiteLab Genomics will apply its proprietary AI-driven predictive modeling platform to improve stable cell line clone selection through in silico simulations, enabling faster and more reliable outcomes. Coupled with Cytiva’s established expertise in AAV production platforms, the collaboration is designed to help drug developers move candidates into the clinic and toward commercialization more efficiently. “Through the integration of AI-driven predictive modeling into AAV development workflows, we aim to reduce development timelines and associated costs by up to 70%,” said David Del Bourgo, CEO and Co-Founder of WhiteLab Genomics. “That efficiency is critical as the industry pushes toward more scalable, commercially viable genomic therapies.” According to Cytiva, the approach will not only save time and cost but also help manufacturers meet regulatory expectations around consistency and scalability. “Genomic medicines will be critical to address some of the world’s greatest health challenges,” said Emmanuel Abate, President of Genomic Medicine at Cytiva. “By combining Cytiva’s experience with WhiteLab’s technology, we intend to help manufacturers reach clinical and regulatory milestones faster, ultimately benefiting patients worldwide.” With mounting pressure across the industry to shorten time to IND and accelerate commercialization, the partnership highlights the increasing role of AI in optimizing advanced therapy workflows. Author BioFocus Newsroom Previous Next

< Back Strategic Partnership Between UK Government and Oxford Nanopore Set to Advance Genomics-Driven Healthcare Oxford Nanopore x UK Biobank x Genomics England x NHS England x UK Government: a landmark collaboration for UK healthcare In a bold move that aligns with the UK Government's vision of creating a healthcare system "fit for the future," a strategic partnership has been forged between Oxford Nanopore, UK Biobank, Genomics England, and NHS England. This collaboration marks a new chapter in biomedical research, leveraging cutting-edge genomic and epigenomic technologies to improve patient outcomes and bolster national biosecurity. The partnership aims to revolutionise healthcare, not only through the development of advanced diagnostic tools but also by enhancing the UK's pandemic preparedness, making it a global leader in genomic innovation. Advancing Patient Care through Genomic Research At the heart of this partnership lies the ambition to transform the diagnosis and treatment of diseases, particularly cancer, rare genetic disorders, and infectious diseases. Genomic insights, which involve the study of DNA to understand genetic diseases and predispositions, have already shown significant promise in personalizing treatments. The integration of Oxford Nanopore’s high-performance nanopore sequencing technology into clinical practice will enable faster, more affordable, and more accessible genomic sequencing, ensuring that healthcare providers can make more precise treatment decisions. Oxford Nanopore's technology excels in providing rich, high-resolution genomic data, capable of uncovering both genetic and epigenetic alterations. These insights are crucial in understanding how changes in DNA contribute to disease. For cancer, this means more accurate identification of mutations that can guide personalized treatment plans, potentially leading to earlier diagnoses and better survival rates. For rare genetic diseases, the ability to pinpoint even the smallest genetic mutations could drastically improve diagnostic accuracy, reducing diagnostic odysseys, and speeding up intervention. The partnership’s focus on pharmacogenomics, where genetic information is used to tailor medications to an individual’s genetic profile, has the potential to significantly improve patient safety and treatment efficacy. This would address a long-standing challenge in medicine, where trial-and-error approaches to prescribing medications often lead to adverse reactions and inefficiencies in care. Preparing for Future Pandemics: Real-Time Pathogen Surveillance Perhaps one of the most ambitious and timely aspects of the partnership is the establishment of a real-time, pathogen-agnostic biosurveillance system, which will span up to 30 NHS sites. This initiative is a response to the lessons learned during the COVID-19 pandemic, where the UK’s life sciences sector demonstrated the power of genomics in tracking viral evolution and identifying emerging threats. By creating a rapid pathogen identification system, this partnership aims to ensure that the NHS can respond quickly to future pandemics and other biological threats. The project will build on successful pilots, particularly in respiratory metagenomics, a program led by Guy's and St Thomas' NHS Foundation Trust. The integration of Oxford Nanopore’s sequencing technology into this system will allow for the rapid characterization of respiratory diseases, including identifying drug-resistant pathogens. By reducing the time it takes to diagnose such diseases from days to just six hours, this program has the potential to transform patient care, allowing for faster, more targeted treatments. This biosurveillance system will not only improve patient outcomes by ensuring timely diagnosis and treatment but also enhance the UK's biosecurity, aligning with the UK Biological Security Strategy . By providing real-time data to the UK Health Security Agency (UKHSA), this partnership aims to place UK scientists and decision-makers ahead of emerging infectious diseases, providing them with critical information to make informed decisions on public health measures and interventions. Strengthening the UK’s Life Sciences Sector Beyond the immediate healthcare benefits, the partnership represents a strategic investment in the UK's life sciences sector, which is poised to become a global leader in genomic and biotechnological innovation. The collaboration should help catalyze economic growth, supporting the development of high-value jobs and fostering a skilled workforce trained in genomics and personalized medicine. With access to cutting-edge technology and training, NHS staff and researchers will be better equipped to navigate the complexities of genomics in clinical practice. It is hoped the initiative will also create opportunities for collaboration between the private and public sectors, further positioning the UK as a biotechnology hub. By accelerating the adoption of innovative genomic technologies into the NHS, this partnership will bridge the gap between scientific discovery and its translation into real-world applications. Author BioFocus Newsroom Previous Next

< Back Sanome Partners With NHS Trusts to Deploy AI-Powered Clinical Intelligence for Earlier Infection Detection MEMORI, a CE-marked AI clinical decision support tool, is being rolled out at two UK NHS hospitals to help clinicians spot hospital-acquired infections sooner. Sanome , the London-based health tech company behind MEMORI, an AI-powered clinical decision support tool that helps clinicians detect hospital-acquired infections (HAIs) earlier, has announced two major hospital partnerships to improve patient care. Earlier this year, MEMORI became the UK’s first multimodal Class IIb CE-marked AI Software as a Medical Device for infection prediction. The Royal Hospital for Neuro-disability and East Kent Hospitals University NHS Foundation Trust have each selected Sanome’s MEMORI platform to support earlier detection of HAIs and clinical decision-making. This comes at a time when health services prepare for soaring pressures during the winter months, with rising admissions, workforce shortages, and seasonal infection spikes placing clinicians under mounting pressure to take swift and decisive action to prevent serious conditions like hospital-acquired infections from escalating. HAIs remain one of the most serious and costly challenges facing the NHS, contributing to over seven million additional patient bed days and £2.7 billion in annual care costs. Early detection is critical for preventing deterioration, easing clinical pressures, and improving patient outcomes. MEMORI analyses real-time patient data using explainable clinical AI to identify emerging infection risk, with early studies showing the potential to surface life-threatening HAI predictions up to three days earlier than standard practice. By flagging high-risk patients sooner and providing clear, actionable insights, the platform helps clinicians recognise deterioration earlier and deliver the right care at the right moment. Embedded directly within electronic patient records (EPRs), MEMORI brings these insights into clinicians’ existing workflows, enabling earlier, more confident decision-making. The Royal Hospital for Neuro-disability, one of the UK’s leading specialist centres for long-term and complex neurological conditions, will become the first specialist neuro facility to embed MEMORI into routine patient care. Patients with complex neurological conditions are among the most vulnerable to infections and associated complications; in fact, more than six in ten of those admitted to intensive care units contract at least one HAI during their stay. Through integration with the PatientSource EPR, MEMORI will support earlier detection across four wards initially, enabling clinicians to intervene sooner for a highly vulnerable patient population where timely action is essential. In addition to the deployment of MEMORI in specialist neurological care, East Kent Hospitals University NHS Foundation Trust, one of England’s largest acute trusts, is also partnering with Sanome to integrate real-time AI insights directly into its EPR system to support early recognition of deteriorating patients. This collaboration lays the groundwork for a scalable new model for safe, secure access to real-time NHS data, supporting thousands of patients across multiple hospital sites. “Partnering with leading healthcare organisations like the Royal Hospital for Neuro-disability and East Kent Hospitals University NHS Foundation Trust marks another major step towards bringing earlier, data-driven infection detection into everyday care for every patient,” said Benedikt von Thüngen, Founder and CEO of Sanome. “Working closely with clinicians, we’ve co-created a platform that not only flags those at risk but fits seamlessly into existing workflows. Our aim is to equip frontline teams with the actionable insights they need to intervene sooner and protect patients, at the same time relieving pressure on already-stretched resources.” Bedside go-live dates at both sites in specialist neurological care are scheduled for the coming months, with additional NHS deployments planned throughout 2026 as Sanome continues to expand its footprint across UK healthcare. Author BioFocus Newsroom Previous Next

< Back Digital Health Gains Still Out of Reach, BMJ Commission Finds Despite heavy investment, a BMJ Future Health Commission survey finds digital health has yet to ease workloads or cut costs, with EHR usability, interoperability, and training gaps undermining clinician trust. The BMJ Future Health Commission has published new findings suggesting that Europe’s rapid investment in digital health infrastructure is yet to yield the anticipated productivity benefits. Drawing on survey data from over 300 healthcare professionals (HCPs) and qualitative interviews across diverse care settings, the report documents a striking gap between optimism for digital transformation and its lived impact on clinical workflows. Fewer than half of respondents reported that digital systems had eased administrative burden (47%), reduced delivery costs (44%), or decreased clinical workload (38%). In contrast, a majority (80%) acknowledged improvements in care delivery, and 76% expressed optimism about healthcare’s digital future. Usability challenges with EHRs Electronic health records (EHRs), the most entrenched digital platform in European health systems, emerged as a paradoxical case. HCPs with the highest exposure to EHRs were significantly less likely to perceive efficiency benefits than their peers. This suggests that while EHRs have succeeded in digitising information, shortcomings in design, interoperability, and integration with clinical practice have limited their capacity to reduce workload. “These findings indicate that poor experiences with EHRs may erode clinician confidence in digital health more broadly, slowing adoption of emerging tools such as predictive analytics, patient-flow optimisation, and remote monitoring systems,” the Commission notes. Trust as a critical determinant The report positions trust as the decisive factor in digital health adoption. It distinguishes between: Foundational trust , established through transparent regulatory standards and certification processes. Operational trust , earned when frontline clinicians are actively involved in the design, selection, and training for new systems. Stephen McAdam, Segment Director for Digital Health at DNV, commented: “Trust is the critical currency of digital health. Rigorous standards ensure baseline safety, but confidence is ultimately secured on the ward, where usability and workflow fit determine whether technologies accelerate or obstruct care.” Five priorities for digital transformation The Commission sets out five evidence-based recommendations for closing the expectation–reality gap: Evaluate organisational confidence in EHRs , addressing usability deficits before scaling. Implement interoperability standards to facilitate secure, seamless data exchange. Commit to longitudinal training programmes that extend beyond deployment and target both clinical and non-clinical staff. Institutionalise clinician and patient involvement in procurement and design decisions to align systems with real-world practice. Strengthen risk management frameworks for data quality, security, and emergent threats. Implications for research and policy The findings arrive as European governments, including the UK, advance long-term digital strategies aimed at alleviating workforce shortages and rising demand. Yet, the Commission cautions that investment in infrastructure alone is insufficient. “Digital health’s promise will only be realised through rigorous implementation science, participatory design, and systematic evaluation of outcomes,” said Dr Helen Surana, Editor in Chief of BMJ Innovations. “Without these, digital transformation risks remaining a policy ambition rather than a clinical reality.” For researchers and policymakers, the report highlights a pressing need for translational studies that evaluate not only the technical capabilities of digital systems but also their impact on workflow, safety, and sustainability in practice. Author BioFocus Newsroom Previous Next

Fujifilm has rebranded key life sciences companies under a unified "Partners for Life" strategy to offer integrated, end-to-end solutions across the drug development lifecycle. < Back Fujifilm Rebrands Life Sciences Units to Strengthen Unified Market Presence Under ‘Partners for Life’ Strategy Fujifilm has rebranded key life sciences companies under a unified "Partners for Life" strategy to offer integrated, end-to-end solutions across the drug development lifecycle. Fujifilm Corporation announced today a strategic rebranding of its life sciences companies aimed at unifying its offerings under a single, integrated identity to better serve customers across the full spectrum of drug development. As part of the overhaul, FUJIFILM Irvine Scientific becomes FUJIFILM Biosciences, and FUJIFILM Diosynth Biotechnologies rebrands as FUJIFILM Biotechnologies. The move is part of a broader initiative to align the company's growing life sciences portfolio under the Fujifilm Life Sciences umbrella with a new tagline: “Partners for Life.” This restructuring is intended to streamline customer engagement and reflect Fujifilm’s growing role as an end-to-end provider of solutions for the biopharmaceutical industry—from discovery through to commercial manufacturing. A unified vision across the drug development lifecycle “By redefining our Life Sciences Group, we also support Fujifilm’s growth strategy for the life sciences sector,” said Toshihisa Iida, corporate vice president and general manager of Life Sciences Strategy Headquarters. “Unifying under a single banner simplifies engagement for our global customers and ensures shared strategy and purpose across all our life sciences teams.” FUJIFILM Biosciences, based in Santa Ana, California, will continue its legacy as a pioneer in cell culture media, building on a 55-year history of innovation. The newly named entity will broaden its scope with a comprehensive portfolio that includes research reagents, recombinant proteins, specialty chemicals, and assay materials. While the new brand takes effect immediately, the legal name change is slated for January 1, 2026. “We’re excited about this evolution,” said Brandon Pence, president and COO of FUJIFILM Biosciences. “By expanding our capabilities and staying true to our core principles—innovation, service, and people—we aim to deepen our impact in the life sciences community.” FUJIFILM Biotechnologies, formerly FUJIFILM Diosynth Biotechnologies, remains a top global CDMO (contract development and manufacturing organization), offering development-to-commercialization services for biologics, advanced therapies, and vaccines. The company retains its legal name but will now operate under the new brand identity. “At FUJIFILM Biotechnologies, we take immense pride in helping bring life-changing medicines to patients,” said Lars Petersen, president and CEO. “This rebrand is about greater coordination and focus—offering our customers scientific rigor, speed, and flexibility.” A $10 billion commitment to life sciences Fujifilm has invested over $10 billion in life sciences over the past 15 years through acquisitions and facility expansions. The company aims to integrate its proprietary technologies—such as AI, imaging, and sensing—with biopharma innovation to drive new value for partners and patients. Alongside the rebranded entities, the Fujifilm Life Sciences Group includes FUJIFILM Cellular Dynamics, FUJIFILM Wako Pure Chemical Corporation, and FUJIFILM Toyama Chemical Co., Ltd., each contributing specialized capabilities to the unified platform. Meet Fujifilm Life Sciences at BIO International The newly rebranded group will showcase its integrated offerings at BIO International Convention 2025 in Boston, June 16–19, at Booths 2334 and 2234. You can find out more aboit BIO International and other upcoming events on the BioFocus event spotlight page . Author BioFocus Newsroom Previous Next

Journey through the story of cell culture media in biopharmaceutical manufacturing - once considered mere cellular 'broth', now a critical component of modern medicine. < Back How Cell Culture Media Feeds the Future of Medicine Journey through the story of cell culture media in biopharmaceutical manufacturing - once considered mere cellular 'broth', now a critical component of modern medicine. Every vial of monoclonal antibody, every bag of viral vector, and every single-use bioreactor relies on an invisible constant: the cells at the heart of biopharmaceutical production must be properly nourished. The liquid that sustains them, the culture medium, is far more than a background ingredient. It is the marrow of the process, driving cell growth and subsequently what the cells produce, which ultimately influences how the final therapy behaves in patients. It is a critical product in the path of a modern biopharmaceutical from lab to patient. In the past, media were often thought of as recipes, an afterthought to the 'real' process of cell culture. Today, they are recognised as one of the most critical levers in biomanufacturing, influencing yield, quality, and even regulatory approval. At the most basic level, cell culture media supply sugars, amino acids, salts, vitamins and lipids. The influence of the medium goes beyond mere nutrition - it dictates how cells use energy, how long they remain viable, and how faithfully they can produce complex proteins. Subtle changes in formulation can alter productivity by orders of magnitude, or shift glycosylation patterns in ways that directly affect potency and safety. The fingerprints of the medium are found in every stage downstream. Cells that are stressed by inadequate feeding release more host cell proteins, which in turn complicate purification. Media that tilt metabolism away from lactate accumulation can ease scale-up and improve process robustness. Essentially, choices in cell culture matter significantly, as they reverberate through manufacturing economics and ultimately patient outcomes. One of the most significant shifts in the past two decades has been the move away from serum. Serum is a fluid supplement added to basal cell culture media that provides a complex mixture of growth factors, hormones, lipids, and minerals crucial for cell proliferation, attachment, and overall survival. The most widely used type is fetal bovine serum, a rich source of necessary macromolecules that are not supplied in the basal medium. Once considered indispensable, serum now poses unacceptable levels of variability and regulatory risk. Today, chemically defined media dominate industrial use. These formulations strip away animal-derived components in favour of precisely measured nutrients, recombinant proteins and controlled additives. Chemically defined formulations are often tailored to a particular cell line, for example, CHO (Chinese hamster ovary) for antibodies, HEK 293 for viral vectors, or primary T cells for cell therapies. The design of these media reflects nutritional needs and the metabolic quirks and stress responses of each system. Companies now treat media as proprietary intellectual property, developed with as much care as any other step in the process. Further to this, companies now offer services that enable clients to customise a unique medium and process for increased titers, quality, and manufacturability by using a multi-omics media development workflow, incorporating insights from the analyses of thousands of components (proteins and metabolites) within the cell, in addition to traditional spent media analysis, to fully understand the nutritional requirements of a cell line. Media development has moved from the bench to the realm of engineering. High-throughput mini-bioreactors and robotic plate assays allow hundreds of candidate blends to be tested in parallel. Statistical methods such as design of experiments help map out the interactions between nutrients, while mechanistic models of metabolism identify potential bottlenecks. More recently, machine learning has entered the picture. Algorithms can predict how changes in composition might affect cell growth or critical quality attributes such as glycosylation. Early work shows that pairing explainable AI with laboratory validation accelerates iteration without turning the process into a black box. The effect has been to move media development away from artisanal tweaking toward a more rigorous, data-driven science. For many years, fed-batch processes dominated biologics production - a basal medium was supplied, then bolus feeds added periodically to extend cell growth. This remains common, but as companies chase higher productivity and smaller manufacturing footprints, attention has turned to intensified fed-batch and continuous perfusion cultures . These new modes place even greater demands on the medium. Intensified cultures require careful control of osmolality and by-product scavenging. Perfusion, in which fresh medium is continuously supplied while waste is removed, depends on stable formulations that can sustain cells for weeks on end without triggering stress responses. Media, in short, are what make such process innovations possible. Because media are complex and can include sensitive biological ingredients, regulators view them as critical raw materials. Manufacturers are expected to demonstrate full traceability, qualify suppliers, and show comparability if a formulation changes mid-development. This has practical implications. Each lot of basal medium or feed requires specification and documentation. Any animal-derived hydrolysates must be assessed for consistency and contamination risk. For licensed products, even small changes in the medium may trigger a comparability exercise with regulators. Suppliers have responded by offering GMP-grade media and, in some cases, manufacturing under dedicated lines to reduce cross-contamination and supply risk. Cell culture media is not just a technical consideration, it's a business in and of itself, and a big one at that. As biologics volumes rise and newer modalities demand specialised formulations, it will only grow. The cost of media can be a meaningful share of overall manufacturing expenses, and suppliers increasingly compete not just on price but on their ability to support process development with data, analytical tools, and regulatory documentation. Several challenges persist in cell culture media. Complex ingredients such as hydrolysates still introduce lot-to-lot variability, while media that perform beautifully in a one-litre bioreactor may behave unpredictably at two thousand litres. Even with machine learning, interpretability and regulatory acceptance of predictive models remain a challenge. Sustainability is another frontier; while the production of biopharmaceuticals is, clearly, a necessary process, it is not an eco-friendly one. The energy footprint of cold storage and transportation is significant, and the adoption of concentrated and more stable media formats is only just beginning. For companies scaling biologics processes, it is clear that media are not interchangeable commodities but controlled, critical materials. Early investment in tailored formulation and feeding strategies pays off in yield, quality, and regulatory piece of mine. As such, media should be co-developed with the process itself, and changes handled with careful documentation and dialogue with regulators. The next decade will see media science become even more predictive, digitised , and personalised. Omics data, mechanistic modelling and explainable machine learning look set to converge to produce formulations designed not just for a cell line, but for a specific product and manufacturing mode. Such media may even reduce downstream burden by guiding cells towards cleaner secretomes. Once viewed as little more than broth, cell culture media is now considered central to biopharmaceutical innovation. They are the environment in which our medicines are born. Author BioFocus Newsroom Previous Next

< Back A New Way to Treat Anorexia? An appetite-stimulating protein has been shown to reverse anorexia in mice, offering new potential for treatment. Anorexia nervosa, commonly referred to as simply ‘anorexia’ is a serious disease - in the US, more than one person dies every hour . In today's society, around 10% of people with an eating disorder suffer from anorexia. Typically, people suffering with anorexia are in early adolescence and young adulthood. It’s a particularly difficult condition to treat because of the interplay between psychological and physiological factors, manifesting as the body essentially attempting to starve itself. In anorexia, the brain, due to complex underlying causes, urges food restriction even when the body is malnourished. Despite the seriousness of anorexia, the scary truth is that there is no simple way to treat it. There are no US Food and Drug Administration-approved drugs; instead typical treatment paths involve simultaneously addressing both psychological and physical problems. However, recent research by Hui Chen et al. , has highlighted a potential new experimental treatment that may offer a new avenue for drug development. How a ‘hunger protein’ may offer potential for treating anorexia Acyl CoA binding protein (ACBP), is an appetite-stimulating protein conserved across all four eukaryotic kingdoms, namely Animalia, Plantae, Fungi, and Protista, and in some eubacterial species. ACBP consists of four domains, each of which are shaped like a bowl and have a highly-exposed Acyl-CoA-binding site. In mice, anorexia caused by chronic resistant stress (CRS) was associated with a decrease in the level of ACBP secretion. In this latest research by Hui Chen et al., a chemical-genetic system was designed which could express more ACBP protein in mice. In transgenic mice, higher levels of ACBP were associated with a reduction in weight loss and a bigger appetite. In addition, the group discovered that daily intravenous injections of ACBP protein or subcutaneous implantation of pumps releasing ACBP mimicked the effect of the chemical-genetic system, offering alternative solutions. You may be wondering: “how does this help people who are struggling with anorexia”? The team took plasma samples of anorexia patients and found that those with lower levels of ACBP had a poorer prognosis compared to those who have a higher level of ACBP. So, as in mice, it seems our ACBP production level plays a key part in how our body regulates appetite level. Importantly, this discovery showcases the potential of ACBP as a target for drug development. Despite this correlation, the path to therapeutic development will not be straightforward because in humans the root cause of anorexia has a large mental health component, and while this treatment might help treat the disorder on a physical level, it does not target the typically complex underlying mental health issues at play within anorexia patients. Is there a possibility that ACBP-protein regulation could do the opposite effect and help treat obesity? Recent research by Bravo-San Pedro et al., explored the opposite to the Hui Chen research group, whereby they neutralised the effect of ACBP by way of systemic injection of neutralising monoclonal antibodies in mice. The results showed that injections gave an anorectic effect (reduced appetite). While GLP-1 receptor agonist drugs like the increasingly popular Wegovy (semaglutide) are showing immense promise in treating obesity, continuing to explore different treatment avenues will be vital. Final thoughts Taken together, both these studies affirm the important role ACBP plays in appetite regulation and affirms the protein as an interesting target for medical research to further explore its use in treating eating disorders and chronic diseases like obesity. Author Polina Kosykh , freelance contributor Previous Next

< Back A Millennia-Old Mutation with Modern Implications A genetic mutation known as CCR5Δ32, originating between 6,700 and 9,000 years ago near the Black Sea, provided ancient humans with a controlled immune response to emerging pathogens and now plays a crucial role in modern HIV resistance and gene-editing therapies. A recent study conducted at the University of Copenhagen has uncovered the origins of a genetic mutation that provides resistance to HIV—a mutation that first appeared in a single individual near the Black Sea between 6,700 and 9,000 years ago. Today, this same mutation, known as CCR5Δ32, is carried by 18-25% of the Danish population and has played a crucial role in developing modern HIV treatments. The CCR5Δ32 mutation deletes a small segment of the CCR5 gene, which encodes a protein on the surface of immune cells. HIV typically uses this protein as an entry point to infect the body, but the mutation disrupts the receptor, making it harder for the virus to take hold. While this protective effect against HIV was discovered decades ago, its ancient origins remained a mystery. By analyzing DNA from over 2,000 modern individuals and 900 ancient skeletons, researchers traced the mutation’s emergence to a single ancestor in the Black Sea region during the Neolithic period. Using AI-powered genetic analysis, they determined that the mutation spread rapidly, suggesting it provided a significant survival advantage long before HIV existed. Why did this mutation spread so widely? HIV has only been around for about a century, so why would a mutation that blocks it have been beneficial thousands of years ago? The researchers propose that CCR5Δ32 may have helped balance the immune system during a time of increasing infectious disease threats. As humans transitioned from hunter-gatherer lifestyles to settled farming communities, population density rose, and so did exposure to new pathogens. An overactive immune response could be deadly—much like the cytokine storms seen in severe COVID-19 cases. The mutation may have tempered excessive inflammation, giving carriers a better chance of survival during outbreaks. "This wasn’t about making the immune system stronger—it was about making it more controlled," explained Professor Simon Rasmussen, senior author of the study. "In an era of emerging diseases, a less aggressive immune response could have been the difference between life and death." The discovery not only solves a long-standing evolutionary puzzle but also reinforces the importance of studying ancient DNA. The same mutation that once helped Neolithic farmers survive is now the basis for HIV therapies, including the controversial (but groundbreaking) CCR5 gene-editing approach used in the "Berlin Patient," the first person cured of HIV. "This is evolution in action—a genetic fluke from the past turning out to be vital in the present," said Kirstine Ravn, lead researcher on the study. "It shows how much we can learn from our ancestors’ DNA." The study , published in Cell, marks a major step in understanding how human genetics and ancient diseases have shaped our biology. Future research could explore whether similar mutations exist for other modern viruses, hidden in the genomes of our distant ancestors. For now, the CCR5Δ32 mutation stands as a remarkable example of how the past continues to influence medicine today—one ancient gene at a time. Author BioFocus Newsroom Previous Next