Search Results

< Back Digital Cognitive Therapy Delivers Striking Cognitive Gains for UK Care Home Residents A digital therapeutic designed to combat cognitive decline in people with dementia has produced remarkable improvements in cognitive and emotional outcomes in a recent UK pilot. The BioFocus team recently sat down with Devika Wood, CEO of Brain+ and a former dementia carer, to discuss the company’s field-advancing work in digital dementia care. We discussed how the Brain+ Ayla Dementia Care platform new therapeutic platform has been a vehicle for demonstrating how data, design, and compassion can reshape one of healthcare’s greatest challenges. Beyond the numbers, Devika shared the deeply human stories of residents who, for the first time in years, began to remember names, childhood moments, and emotions thought long lost, allowing them to regain dignity and connection in their later stages of life. The study, conducted by dementia technology company Brain+ in collaboration with Southcare Homes Group, demonstrated that seven weeks of digitally delivered Cognitive Stimulation Therapy (CST) via the company’s Ayla Dementia Care Platform led to a 47.8% improvement in overall cognitive outcomes among residents with mild to moderate dementia. Measured gains were seen across several key cognitive domains: Planning and executive function: +66.3% Recognition and memory: +56.5% Task switching: +48.3% Communication and understanding: +42.3% Participants also reported higher mood and quality-of-life scores. Average mood improved from 3.7 to 4.2 out of 5, while quality-of-life ratings (spanning energy, mood, memory, and self-perception) rose from 1.98 to 2.65. Residents rated the overall experience 9.6 out of 10, and 80% said they would recommend CST to others. These results, described by Brain+ as a “transformational step” in accessible dementia care, demonstrate the feasibility of delivering evidence-based cognitive therapy at scale through digital means. Facilitating the digitalisation of archaic paper processes CST is a non-pharmacological intervention endorsed by both the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE) for use in people with mild to moderate dementia. It is the only non-drug therapy formally recommended for NHS delivery, with clinical trials showing benefits in cognition, communication, and mood, and evidence that it can delay cognitive decline by up to six months. Traditionally, CST is delivered through structured, themed group sessions, typically five to eight participants, run by trained facilitators. However, the format has remained largely analogue since its inception, relying on laborious paper-based documentation and significant preparation time. “The CST manual looks like an encyclopedia,” said Devika Wood. “Facilitators typically spend hours designing each session in line with the handbook. We developed Ayla to digitise the entire process, essentially turning CST into a plug-and-play digital therapy that can be delivered quickly, consistently, and at scale”. Ayla, a Class I medical device (meaning it can be delivered via healthcare providers including the NHS), provides more than 180 clinically validated activities structured across 14 sessions, each designed to stimulate specific cognitive and social domains. It also integrates data capture tools to record and analyse outcomes in real time, enabling care teams to track progress and tailor therapy to individual needs. Devika compared Ayla’s role in dementia care to the way digital platforms such as SilverCloud transformed cognitive behavioural therapy for mental health. “We refer to Ayla as a means of bringing CST into the digital age”, she said. “It standardises delivery, collects measurable data, and empowers care staff to deliver best-in-class therapy even in resource-constrained environments”. Measurable benefits and the human impact While the quantitative results of the pilot were impressive, the qualitative feedback was equally compelling. At Southcare Homes’ Grasmere and Lime Tree House sites, where the pilot was conducted, staff reported visible improvements in residents’ engagement, mood, and communication within just a few sessions. Antony Noad, Activity Coordinator at Southcare Homes, recalled the transformation of one resident who had not smiled in months. “Some of the participants had real barriers around certain memories, which they could no longer access. One particular person, for example, couldn’t talk about their childhood. “There was a wonderful moment when a memory was triggered and the whole atmosphere changed: all the pretence and defensiveness went out of their voice, and you could see them connect emotionally to their past experience”. Another participant, Tom Miller, who had long been unable to discuss his early life, began recounting vivid stories from his childhood during therapy. Vicky Miller, daughter of Southcare resident Tom Miller, who took part in the pilot, said: "Dad’s short term memory is slightly better, and he remembers my son’s name. He’s also more sociable, less easily triggered, and his interactions with other residents are a lot more positive. I’m really pleased to see the progress he’s made!”. From speaking with Devika, it is clear that these personal accounts underscore the importance of the work, especially against the backdrop of her own personal experiences in caring for her nan, who suffered from the disease. Devika commented: “You just don't understand the power of it until you sit there and you see how the recipients come alive. And they deserve it. These are the people that were the cornerstones of our society. They were our parents and our grandparents. They deserve to be listened to and to be asked about their lives”. “This report doesn’t just represent numbers; it represents people and the moments of reconnection that every person living with dementia deserves,” she said. “It has been a privilege to work alongside Southcare Homes and see first-hand the difference technology can make when implemented with compassion.” Meeting a growing national challenge There are currently an estimated 982,000 people living with dementia in the UK, a figure projected to rise to 1.4 million by 2040. With as many as three in four care home residents affected, the need for scalable, cost-effective therapies is becoming critical. Devika believes that digital delivery of CST is a key part of the solution. “One of the biggest barriers to dementia care is limited workforce capacity” she explained. “By digitising therapy and training existing care staff to deliver it, we can expand access without adding pressure to the NHS. CST is most effective when introduced early, so it belongs in primary and community care, not only in secondary services”. On the pilot study, Karim Nanji, proprietor of Southcare Homes Group, said that “ working with the Brain+ team in introducing Ayla to our team and residents has been groundbreaking. We were thrilled to be the first UK-based care home group to partner with this exceptional team, whose dedication and passion match ours. Through step-by-step training, both in person and virtual, our team has been able to learn how best to deliver the Ayla initiative in an effective, caring and person-centred manner”. Following the pilot’s success, Southcare Homes has confirmed plans to implement Ayla across its wider group of care homes. Dementia: data, doubt, and the distance still to go While the early data from the Ayla pilot are undeniably encouraging and have the potential to drastically improve patients’ lives, it must be noted that CST is a complementary therapy, not a cure. Dementia remains a progressive, neurodegenerative condition with no treatment capable of halting or reversing its underlying pathology. CST, whether delivered digitally or in person, does not alter the biological mechanisms of diseases such as Alzheimer’s or vascular dementia. Instead, it targets neuroplasticity, engagement, and quality of life, helping patients make the most of their remaining cognitive function. The Ayla pilot’s 47.8% improvement figure, though striking, should also be interpreted carefully. The study involved just 12 participants across two sites, with no placebo or control group for direct comparison. While the use of Likert-based outcome measures aligns with CST research standards, further randomised controlled trials (RCTs) and long-term follow-ups will be essential to confirm the durability of these effects and rule out potential bias. That said, the pilot represents an important proof of concept: that evidence-based, person-centred therapies can be made scalable through digital innovation. For a condition where pharmacological progress remains slow and fragmented, the potential societal impact of sustained cognitive gains is enormous. As Brain+ continues to expand its research, the hope is that digital therapeutics like Ayla can fill a vital gap between diagnosis and long-term care, bridging clinical science and human connection in one of the most pressing health challenges of our time. What's next for Brain+ For Brain+, the pilot marks only the beginning. The company has initiated a new collaboration with a GP practice participating in a dementia-led care strategy, exploring how CST can be integrated at the point of diagnosis. “Early intervention is essential,” Wood said. “We are testing delivery of CST groups in primary care settings for newly diagnosed patients and will use the outcome data to demonstrate the benefits of early, community-based therapy.” Alongside its UK expansion, Brain+ is pursuing international partnerships in Australia, Canada, and other markets, including at-home care services. “Our aim is to embed CST globally as a first-line intervention for dementia and make this the gold standard care option” Wood added. “We want to give people not only longer lives, but better lives”. About the Ayla Dementia Care Platform Ayla is a digital toolkit that replicates the structure and clinical integrity of the original CST programme while reducing preparation time by more than 50%. The platform includes a 14-session, NICE-aligned framework with over 180 evidence-based activities targeting memory, language, problem-solving, and social engagement. Co-designed with care providers and individuals living with dementia, Ayla integrates seamlessly into existing care routines, enabling care homes to deliver standardised, measurable therapy while improving staff confidence and efficiency. About Brain+ Brain+ is a Copenhagen-founded digital therapeutics company developing non-pharmacological treatments for dementia and cognitive impairment. Its mission is to make evidence-based cognitive therapies accessible at scale through digital innovation and data-driven care delivery. Author BioFocus Newsroom Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

< Back Enterprise Therapeutics Advances a Promising New Approach for Cystic Fibrosis Positive Phase 1 data highlight strong safety, lung retention and momentum toward a new inhaled therapy for people with cystic fibrosis. Enterprise Therapeutics has reached an important milestone in its mission to improve the lives of people living with respiratory disease, announcing the publication of positive Phase 1 clinical data for ETD001 in The Journal of Cystic Fibrosis . The peer-reviewed paper highlights the safety, tolerability and favourable pharmacological profile of ETD001, a novel, long-acting inhaled epithelial sodium channel (ENaC) blocker being developed for the treatment of cystic fibrosis (CF). The publication marks a significant step forward for Enterprise and for the CF community, reinforcing the potential of ETD001 as a differentiated therapy designed to address one of the root causes of lung disease in cystic fibrosis: impaired mucociliary clearance. A well-tolerated, long-acting ENaC blocker The Phase 1 study evaluated single and multiple ascending inhaled doses of ETD001 in healthy participants, at dose levels predicted to be therapeutically relevant in humans. Results showed that ETD001 was well tolerated, both as a single dose and when administered twice daily for up to 14 days. Importantly, the compound was safely administered at doses higher than those predicted to deliver long-lasting improvements in mucociliary clearance based on preclinical models. Unlike earlier generations of inhaled ENaC blockers, ETD001 demonstrated a pharmacokinetic profile consistent with slow absorption from the lung into systemic circulation. This behaviour supports prolonged retention in the lung and the potential for an extended duration of action, key attributes for a chronic inhaled therapy intended to improve airway hydration and mucus clearance. Another notable finding from the study was the absence of clinically meaningful effects on blood potassium levels. Because ENaC blockade in the kidney can influence potassium balance, this has been a historical concern for drugs in this class. In the Phase 1 trial, potassium levels remained within normal limits at all doses evaluated, further supporting the favourable safety profile of ETD001. Strong alignment between preclinical and clinical data The consistency between preclinical and clinical findings is a standout aspect of the published results. Preclinical studies had previously shown that ETD001 combines a good safety profile with sustained activity in the lung for more than 16 hours following a single inhaled dose. The Phase 1 data closely mirrored these expectations, increasing confidence in the translational robustness of Enterprise’s approach. This strong alignment de-risks further development and underpins the company’s decision to advance ETD001 into Phase 2 clinical testing in people with cystic fibrosis. Addressing an unmet need in cystic fibrosis Despite major advances in CF care, significant unmet needs remain, particularly for individuals who are genetically unsuited to CFTR modulator therapies or who continue to experience progressive lung disease despite treatment. Thick, dehydrated mucus in the airways leads to impaired mucociliary clearance, recurrent infections and chronic inflammation, driving a gradual decline in lung function. By inhibiting ENaC in the airway epithelium, ETD001 is designed to restore airway surface hydration, improve mucus clearance and ultimately support better lung function. This mechanism is complementary to existing therapies and has the potential to benefit a broad range of people with CF. Dr Henry Danahay, Head of Biology at Enterprise Therapeutics and lead author of the publication, commented: “There is an urgent need for new therapies to treat mucus obstruction in the lungs of people with CF, and especially those who are genetically unsuited to CFTR modulators. We are passionate about working towards treatments that will benefit all people with cystic fibrosis and are excited to publish these promising results from our Phase 1 trial.” Momentum continues with Phase 2 underway Building on the positive Phase 1 findings, Enterprise is currently conducting a Phase 2 clinical trial (NCT06478706) to evaluate whether 28 days of treatment with ETD001 can improve lung function in people with cystic fibrosis. Headline data from this study are anticipated in early 2026. With cystic fibrosis affecting more than 100,000 people worldwide and an average life expectancy of around 60 years, innovation remains critical. The publication of ETD001’s Phase 1 data represents meaningful progress toward a new class of inhaled therapies aimed at improving daily respiratory health and long-term outcomes for people living with CF. As Enterprise Therapeutics continues to advance ETD001 through clinical development, this latest milestone underscores the company’s commitment to science-driven innovation and to delivering therapies that have the potential to make a real difference for patients. Author BioFocus Newsroom Previous Next

£400 Million Expansion Strengthens the UK Life Sciences Sector, Enhances Biomanufacturing Capacity, and Supports NHS and Global Pharmaceutical Innovation. < Back FUJIFILM Biotechnologies Launches UK’s Largest Single-Use Biomanufacturing Facility £400 Million Expansion Strengthens the UK Life Sciences Sector, Enhances Biomanufacturing Capacity, and Supports NHS and Global Pharmaceutical Innovation. FUJIFILM Biotechnologies has officially opened the UK’s largest single-use biomanufacturing facility, representing a £400 million expansion of its North East operations. The 110,000 sq. ft. state-of-the-art facility will support the NHS and pharmaceutical partners in developing and producing innovative medicines and vaccines for conditions ranging from Alzheimer’s disease to prostate cancer and rare diseases. As part of the expansion, FUJIFILM Biotechnologies also unveiled the Bioprocess Innovation Centre UK (BIC UK), a centre of excellence for process development and one of the largest laboratories of its kind in the country. Combined, the new facilities make the Teesside campus one of the largest biopharmaceutical manufacturing sites in the UK, with a total footprint of 1.6 million sq. ft. Strengthening the UK life sciences sector The investment comes at a critical time, when several high-profile life sciences projects have been scaled back or withdrawn from the UK. FUJIFILM’s expansion signals strong confidence in the UK’s sector and underlines the enduring strength of UK–Japanese trade relations. The site is designed to work closely with FUJIFILM’s sister facility in Toyama, Japan, enabling seamless global technology transfer and alignment. Toshihisa Iida, Chairman of FUJIFILM Biotechnologies, said: "The opening of our UK expansion enables us to support our partners’ products from early-stage process development to clinical manufacturing – from therapies for ultra-rare diseases to commercial biologics – all from a single, integrated site." Lars Petersen, President and CEO, added: "This facility represents the first small- and mid-scale manufacturing site in our global kojoX network, providing our partners with flexibility, scalability, and reliability. It ensures that medicines reach patients in the UK and around the world efficiently and safely." Advanced capabilities and innovation The new site is equipped with 2,000 L and 5,000 L single-use bioreactors, offering up to 19,000 L total capacity for small- and mid-scale antibody manufacturing. The facility also incorporates FUJIFILM’s SymphonX™ downstream processing skid , enabling fully integrated downstream unit operations and flexible scaling across multiple processes. BIC UK complements these capabilities with high-throughput and continuous process development laboratories, doubling the campus’ existing lab footprint and establishing the UK site as a global centre of excellence for biomanufacturing innovation. Jonathan Haigh, Senior Vice President and Head of UK Site, said: "Through partnerships with the University of Edinburgh, University of Manchester, and University of York, we are building a strong STEM talent pipeline and nurturing the next generation of life science specialists. This expansion strengthens the North East as a leading biomanufacturing hub in the UK and Europe." Endorsements from government and industry The opening was attended by Health Innovation Minister Dr Zubir Ahmed. Senior representatives from government and industry, including Chancellor of the Exchequer Rachel Reeves, Science Minister Lord Vallance, British Ambassador to Japan Julia Longbottom, and Jane Wall, Managing Director of the BioIndustry Association, also provided statements in support of the expansion. Chancellor Rachel Reeves commented: "This investment is a vote of confidence in the UK as one of the best places in the world to develop and manufacture cutting-edge medicines and vaccines. The North East is a hub of innovation, creating high-skilled jobs and strengthening our life sciences supply chain." Dr Zubir Ahmed added: "This expansion demonstrates the UK’s continued attractiveness for life sciences innovation, supporting medical breakthroughs and delivering therapies that improve patient outcomes." Jane Wall, Managing Director of the BioIndustry Association, said: "FUJIFILM Biotechnologies’ £400 million investment showcases the North East as a place to build globally competitive biomanufacturing capability. It delivers cutting-edge technology, high-value jobs, and long-term vision for the UK sector." Sustainable and future-ready The facility is fully electrified and maximises renewable energy usage, aligning with FUJIFILM Holdings Corporation’s sustainability goals. The UK site now provides enhanced manufacturing capacity, innovation leadership, and talent development, positioning it as a cornerstone of FUJIFILM’s global biomanufacturing network. With over 960 employees in Teesside and 5,000 globally, FUJIFILM Biotechnologies continues to support both the NHS and international pharmaceutical companies, delivering high-quality biologics and advanced therapies at scale. Author BioFocus Newsroom Previous Next

Pfizer has announced it will no longer develop or sell Beqvez, its hemophilia B gene therapy, in any global markets. < Back Pfizer Pulls Out of Hemophilia B Gene Therapy, Signaling a Shift in Strategy Pfizer has announced it will no longer develop or sell Beqvez, its hemophilia B gene therapy, in any global markets. Just weeks after ending its partnership with Sangamo Therapeutics on a separate hemophilia gene therapy, Pfizer has announced it will no longer develop or sell Beqvez, its hemophilia B gene therapy, in any global markets. The decision, first reported by Nikkei Asia , stems from what Pfizer describes as “limited interest” from both patients and doctors in gene therapies for hemophilia. Beqvez, a one-time treatment, was approved by the FDA in April 2024 with a staggering $3.5 million price tag per dose. This move suggests Pfizer may be backing away from hemophilia gene therapies altogether. In late 2024, the company also abandoned its partnership with Sangamo Therapeutics on giroctocogene fitelparvovec , a gene therapy for hemophilia A designed to restore the body’s ability to produce Factor VIII , a crucial clotting protein. Pfizer never provided a clear reason for dropping the project, only stating that it had decided not to move forward with regulatory or commercial plans. A Shift Toward Alternative Hemophilia Treatments While gene therapies may be losing favor at Pfizer, the company is still investing in hemophilia treatments. According to Reuters , the pharma giant remains committed to Hympavzi , a monoclonal antibody that helps promote blood clotting. Approved by the FDA in October 2024 for both hemophilia A and B in adults and adolescents, Hympavzi is administered weekly via subcutaneous injection. A Larger Issue for Hemophilia Gene Therapies? Pfizer’s exit from the gene therapy space may reflect broader challenges in the market. BioMarin’s Roctavian, the first-ever hemophilia A gene therapy , won FDA approval in June 2023 with a price tag of $2.9 million. However, the market response was underwhelming. By August 2024, BioMarin scaled back its commercial push, focusing only on the U.S., Germany, and Italy , where the treatment had both approval and reimbursement support. BioMarin’s latest earnings report revealed that Roctavian generated just $26 million in revenue in 2024—a modest return given the therapy’s high price. Meanwhile, Novo Nordisk is taking a different approach. Earlier this month, the company reported that its bispecific antibody, Mim8 , effectively reduced bleeding episodes in pediatric hemophilia patients. Novo Nordisk plans to seek regulatory approval for Mim8 this year, supported by additional Phase III data highlighting its effectiveness in adults and adolescents. Unlike one-time gene therapies, Mim8 offers flexible dosing options, with administration available once a week, every two weeks, or once a month. It seems that nothing can stop the Danish pharmaceutical giant at the moment. Hemophilia Treatment Outlook As Pfizer steps back from gene therapies, it’s clear the industry is still grappling with the best way to treat hemophilia. High costs, uncertain long-term efficacy, and limited patient demand seem to be hampering adoption of one-time gene therapies, while more traditional and flexible treatment options like monoclonal antibodies continue to gain traction. Whether the gene therapy model will ultimately succeed in hemophilia remains an open question—but for now, major players like Pfizer appear to be moving in a different direction. Author BioFocus Newsroom Previous Next

Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. < Back Sartorius Expands Drug Discovery and Biomanufacturing Deal with NVIDIA Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. Sartorius, a leading life sciences and bioprocessing company, has expanded its collaboration with NVIDIA, a pioneer in AI-powered computing. This partnership aims to leverage AI technology to enhance drug discovery and biomanufacturing processes. The collaboration Since 2020, Sartorius has integrated NVIDIA’s technology into its instruments, enhancing live-cell imaging and AI assays. The collaboration focuses on developing predictive AI models, particularly for stem cell-derived organoids, to replace animal models in drug discovery and precision medicine. Expansion highlights NVIDIA Clara Suite: Sartorius will increase the use of NVIDIA Clara's AI-powered computing platforms and services. Predictive Models: New predictive AI models, tools, and simulations will be developed for various applications, available through the NVIDIA Clara suite and DGX platform. Advanced Technologies: The partnership will explore 3D-bioprinted spheroids, organoids, and synthetic biological pathways designed with Sartorius cell lines to create novel therapies. Impact on bioprocessing The expanded partnership aims to simplify and accelerate biopharma drug discovery and manufacturing, promising technological innovations that benefit both Sartorius customers and patients. Sartorius and NVIDIA’s enhanced collaboration signifies a step forward in integrating AI with life sciences, potentially revolutionizing drug discovery and biomanufacturing by providing advanced predictive tools and improving efficiency and product quality in the biotech industry. Author BioFocus Newsroom Previous Next

< Back Defrosting Pandora’s Box: Eukaryotic Viruses Revived as Permafrost Melts The Claverie group reveal thirteen newly discovered 'zombie viruses' from ancient samples of Siberian permafrost. Last year, Jean-Michel Claverie and his research group in Information Genomique and Structurale at Aix Marseille University released ‘An update on Eukaryotic Viruses Revived from Ancient Permafrost’. Published in Viruses, the paper revealed thirteen newly discovered viral isolates from ancient samples of Siberian permafrost. Crucially, the study confirms the ability of these viruses to remain infectious after being frozen for over 48,500 years. This research followed on from the Claverie group’s previous findings in 2014 and 2015 from the Claverie group of two fully infectious eukaryotic viruses from a 30,000 year old permafrost sample in 2014 and 2015 . As noted in the most recent paper, the lack of new isolates uncovered since 2015 is not necessarily indicative of a lack of infectious viruses. The group reports findings of numerous infectious eukaryotic viruses, however they remain to be genomically categorised. The thirteen viral isolates reveal another concern as a result of global warming. Bacterial and eukaryotic viruses up to 48,500 years old have been reactivated by the group, and as the permafrost which contains them melts, there is a risk that these viruses will be revived outside of the lab. As permafrost melts Global rising temperatures act on permafrost much like a microwave on defrost setting. As the Earth warms, permafrost thaws and ice becomes liquid water. This change of state triggers the metabolic reactivation of microorganisms in the soil, such as bacteria, archaea and fungi. There can be two outcomes from this reactivation. One is that defrosted, active microorganisms are able to decompose organic material into CO2 and methane gas, which then further adds to greenhouse gases and so rising global temperatures. Another, one which poses a more immediate public health threat, is the physical release and reactivation of so-called “zombie” bacteria and archaea which have been trapped in cryptobiosis (the state of metabolic inactivation organisms enter upon extreme climate conditions) in the permafrost. Activating ancient viruses For the defrosted bacteria, this health threat is not a major concern. Antibiotics are effective at targeting a range of bacterial infections as they generally work similarly between bacteria types meaning ancient bacteria are likely to be able to be treated with our modern antibiotics. Defrosted ancient viruses, on the other hand, may pose a much greater risk. Within modern viral infections, each different type of virus requires different vaccines or antiviral agents. This is because viruses often work in different ways, targeting different pathways in the body; viruses don’t have universally conserved druggable processes. Ancient viruses, despite being dormant in permafrost for tens of thousands of years, when woken from cryptobiosis could be equally tricky to protect against. An example of the havoc wreaked by such defrosted infectious diseases can be seen in the devastated reindeer populations in 2015 and 2016, which have been linked to the release of Bacillus anthracis spores from permafrost after exceptionally hot summers. Such devastation, according to Claverie, is not a small threat but a large hazard which we are quite likely to see as a result of melting permafrost. Knowing more about the potential strains that may be released as a result of permafrost defrosting due to climate change could act as some protection against them. Acanthamoeba safety Awakening ancient infectious bacteria and eukaryotes raises obvious safety concerns. Certain labs can facilitate exploration of viruses more safely due to their safety procedures. Another way to activate viruses without creating a risk of infection to humans/plants/animals is to use a species which is genetically very far removed. Acanthamoeba spp . was used by the Claverie group as the safest way to infect a species without risk of infection, due to its evolutionary distinction from the human/plant/animal genus. Acanthamoeba is useful not only for its safety but also for its ability to live in a multitude of environments: water taps, flowerpots, dust particles, marine waters and more. Detecting their viruses may be an indicator for other live viruses in a given setting. With this safety blanket in place, the Claverie group was able to reactivate thirteen viral isolates from the different samples. Seven of the thirteen isolates were found to be new members of the Pandoraviridae family. Each of the isolates are thought to be distinct both from each other and also contemporary viral strains, and using radiocarbon dating techniques, the oldest sample was dated as being more than 48,500 years old. After tens of thousands of years spent dormant in permafrost, large DNA viruses are still infectious to Acanthamoeba . Limits of Detection These findings, and unpublished findings from the same group, indicate a large population of potential viruses which could be reawakened as permafrost defrosts. However, the detection of positive viral cultures in the study was conducted using light microscopy. This means that smaller, non-lytic viruses are likely to have passed through microscopy studies undetected; there is likely an even greater population of viruses that can survive in ancient permafrost and more still which may exist that do not infect Acanthamoeba . Author Frances Briggs , freelance contributor Previous Next

Exploring the shift towards digitalisation in bioprocessing, from AI and cloud-based systems to overcoming challenges like regulatory hurdles, cost, and standardisation, while driving efficiency, compliance, and collaboration in bioprocessing. < Back Navigating the Digitalisation Journey in the Biopharmaceutical Industry Exploring the shift towards digitalisation in bioprocessing, from AI and cloud-based systems to overcoming challenges like regulatory hurdles, cost, and standardisation, while driving efficiency, compliance, and collaboration in bioprocessing. The bioprocessing industry, which typically involves the use of living organisms, cells, or their components to produce valuable products, has traditionally been slower than other sectors in adopting digitalisation. This slow adoption is often due to long-term reliance on manual processes, strict regulatory requirements, and resistance to change. However, digital technologies have been gradually transforming bioprocessing, enhancing efficiency, data management, and process optimisation over recent years. Current adoption A recent event held in 2024 hosted by partnerships between University College London and Accenture Innovation called "Reimagining the Future of Biopharma Digitalization”, gathered key stakeholders from across the biopharmaceutical sector, including academics, manufacturers, vendors, consultants, and policymakers. The findings from participants in this event highlighted that 46% of respondents are currently using a hybrid system combining digital and paper-based records, with partial data lakes and process analytical technologies (PAT) in development. This suggests that while digitalisation is progressing, more than half of bioprocessing organisations still rely on traditional record-keeping methods. Additionally, 32% of participants from the survey carried out reported primarily using paper records supplemented by an online data-management system that lacked PAT. This reflects the transitional phase many companies are in, where digital tools are being introduced but not yet fully integrated. The push toward digitalisation has been largely driven by several factors including cost efficiency, operational flexibility, and process optimisation. Companies are leveraging digital tools to streamline workflows, reduce waste, and improve manufacturing efficiency. For example, AI and machine learning allow for predictive modelling that can optimise bioprocesses and find anomalies in real-time. One of the first steps towards fully incorporating digitalisation is the removal of paper-based records and replacing them with digital batch records and automated data capture systems. This shift helps reduce manual data transfers, while minimising errors and enhancing productivity. By adopting Electronic Lab Notebooks (ELNs) and Manufacturing Execution Systems (MES) over traditional paper-based systems, there will be improved traceability and streamlined manufacturing. Many mid-to-large-sized companies in the industry began digitalising batch records by mid-2000s, significantly reducing paper records on manufacturing floors. However, legacy paper-based systems persist in some areas due to organic growth and prioritisation of investment. Process automation and the integration of data analytics are now expected across biomanufacturing sites, enabling companies to gain better process insights and control. Interestingly, the COVID-19 pandemic served as a major catalyst for digital adoption. The urgent need to develop and manufacture vaccines led to collaboration between biopharmaceutical companies and regulatory agencies, which accelerated the implementation of digital technologies to improve production efficiency and regulatory compliance. In contrast, smaller companies have taken a more targeted approach, adopting digital capabilities that address immediate operational, and compliance needs to help provide competitive advantages. For example, contract service providers in particular, leverage digitalisation strategies to enhance flexibility, scalability, and collaboration with customers and regulators. A compelling example of digitalisation in the bioprocessing industry involves the collaboration between Cytvia and Biogen. Here, they wanted to identify gaps and potential risks that were missed during processes. By combining process data from the manufacturer with detailed raw material data from the supplier, they applied AI-driven models to predict key attributes and improve control and risk mitigation. They demonstrated how digitalisation can drive process improvements, enhance quality assurance, and reduce batch failures by leveraging real-time and retrospective data analysis. Furthermore, they showcased the importance of long-term partnerships and trust between parties for successful digital adoption. Barriers to adopting digitalisation As the industry continues this digital transition, the integration of cloud-based systems, AI-driven analytics, and automation is expected to drive further advancements. While efforts are being made to promote the adoption of digitalisation in the industry, there are several challenges that persist. Firstly, many professionals prefer reliance on traditional bioprocessing methods due to concerns about digitalisation causing potential disruptions. With the lack of expertise and training in operating newly digitalised facilities, companies are hesitant to fully digitalise. Strict regulatory frameworks also pose a significant challenge, as they require thorough validation before adopting new digital systems. Ensuring data integrity and compliance with these guidelines adds further complexity. For example, companies need to consider Computer software assurance (CSA) and computer systems validation (CSV) when developing new systems for use in drug manufacturing. With machine learning-based systems, new validation approaches are required, further complicating the process. Standardisation also remains an issue, as different data formats and the interoperability between systems are not well defined. With many of these systems being complex, there are challenges with the integration of digitalisation into existing systems, as many facilities depend on legacy systems that are difficult to align with newer digital solutions. Additionally, costs are also a large barrier in adopting digitalisation, with initial capital expenditure being expensive. Companies need to invest significantly in software, hardware, labour, and training their employees in using the new systems efficiently and correctly, and this can be particularly challenging for smaller companies. Lastly, while the introduction of cloud-based systems can enhance data management in the bioprocessing industry, they introduce cybersecurity risks and potential data breaches. Companies must carefully consider these while ensuring compliance with global data protection regulations, adding another layer of complexity to adopting digitalisation. Future of digitalisation In terms of future outlooks of digitalisation in the bioprocessing industry, it will become increasingly common and points to widespread adoption. At the previously mentioned event, almost 74% of industry stakeholders indicated that digitalisation plays a major role in their current activities. This reflects a strong commitment to embracing Industry 4.0, along with digital tools and processes. To successfully integrate digital tools into existing bioprocessing systems, there are several key areas to focus on. The first steps involve understanding the data landscape and identifying the processes that would benefit most from digitalisation to unlock value across operations. AI methods and machine learning will play significant roles in automating processes, along with the application of digital twins to create virtual models that enable real time simulations and predictive maintenance. AI-driven control will also enhance efficiency and reduce batch failures. Companies are expected to move towards fully digital workflows, focusing on end-to-end digitalisation by integrating cloud-based platforms and blockchain technology to enhance traceability and compliance. With standardisation remaining a significant challenge, attempts will be made to complement data formats and integrate distinct digital systems. The adoption of common standards will facilitate seamless data exchange and analysis across the industry. Arguably, the most important aspect of digitalisation in the industry will involve stronger strategic collaborations between manufacturers, suppliers, and regulators. There will be an increasing emphasis on fostering long-term partnerships based on shared data and process insights, driving continuous innovation and efficiency in the bioprocessing industry. Author BioFocus Newsroom Previous Next

< Back Killing Mosquitoes With the Smell of Flowers Researchers manipulate killer fungi to lure in and eliminate malaria-carrying mosquitoes. As the fight against malaria and other mosquito-borne diseases continues, it is imperative that we introduce novel solutions to control mosquito populations. Inspired by mosquitoes’ attraction to flowers for finding nectar, scientists have engineered fungi to release a floral scent, leading the unsuspecting mosquitoes to their eventual demise. Despite the introduction of the malaria vaccines RTS,S in 2021 and R21 in 2023, malaria cases continue to rise, reaching approximately 282 million cases in 2024 – an increase of 9 million cases from the previous year. The WHO World Malaria Report highlights antimalarial drug and insecticide resistance as major barriers to eliminating malaria, emphasising the need for novel interventions. With current mosquito control methods facing growing limitations, what are the alternatives? In a study published in Nature , an international research team spanning China, Burkina Faso, and the US engineered the mosquito-killing fungi as a promising answer to this question. Co-author and Professor of Entomology at the University of Maryland, Raymond St. Leger, explained that “after observing that some types of fungi could trick mosquitoes into thinking they were flowers, we realized we could turbo-charge the attraction by engineering fungi to produce more longifolene, a sweet-smelling compound that’s already very common in nature. Before this study, longifolene wasn’t known to attract mosquitoes. We’re letting nature give us a hint to tell us what works against mosquitoes.” Metarhizium fungi were used thanks to their mosquitocidal spores and limited off-target effects. Longifolene-laced fungi present a more environmentally friendly alternative, with the chemical having a long safety record for its use in perfume. St. Leger said, “We've also designed the fungus and its containers to target mosquitoes specifically rather than any other insects and longifolene breaks down naturally in the environment”. The specificity of the fungus is a major advantage, as conventional insecticides used to control mosquito populations are toxic towards the environment, wildlife, and human health. Unlike insecticides, resistance to the killer fungi is less likely to arise as it builds upon an evolutionary necessary mechanism. “It'll be very difficult for them to overcome that hurdle, and we have the option of engineering the fungus to produce additional floral odors if they evolve to specifically avoid longifolene” St. Leger explained. These killer fungi are particularly exciting as they are easily cultivated using common scraps from harvesting, like rice husks. This presents a more sustainable solution for less economically developed countries in the global south, where malaria is most prominent. However, rising global temperatures threaten to spread mosquito growth to countries outside of tropical regions, carrying malaria and other mosquito-borne diseases with them. “Mosquitoes love many of the ways we are changing our world,” St. Leger said. “Right now, we’re hoping to use these approaches in Africa, Asia and South America. But one day, we may need them for ourselves.” Although laboratory and computer-based findings show promise, more research must be done to establish success in real mosquito environments. The international team, including St. Leger, are currently facilitating larger outdoor trials with the hope of approval from regulatory bodies. Author Will Smears , freelance contributor Previous Next

< Back The Applications of Wearable Biosensors Wearable biosensors provide continuous, real-time tracking of critical health markers, driving advancements in chronic disease management, early diagnosis, and tailored personalized care. Biosensors are devices designed to detect and quantify biological or chemical substances by converting a biological response into an electrical signal. They normally consist of three components: a biological element such as an enzyme, antibody, or nucleic acid; a transducer that converts the biological interaction into a signal; and a signal processor that interprets the data . Biosensors are valuable across diverse fields, including health diagnostics, environmental monitoring, and food safety assessments. Wearable biosensors, also known as wearables, have gained significant traction due to their potential to provide non-invasive, continuous, and real-time monitoring of physiological and biochemical markers. These markers include glucose, cortisol, heart rate, and hydration levels, which are analysed through biofluids such as sweat, saliva, and interstitial fluid. These systems are integrated into portable, skin-adherent devices such as smartwatches, patches, or smart garments, and utilise technologies such as electrochemical, optical and piezoelectric sensing . Electrochemical biosensors detect substances like lactate and glucose, converting the molecular concentrations into electrical signals. Optical biosensors use light to identify the presence of molecules by detecting changes in light absorption and fluorescence. This principle is used in pulse oximeters to measure blood oxygen levels. Piezoelectric biosensors rely on the piezoelectric effect to detect changes in pressure, mass, or stress, converting them into electrical impulses, commonly used to monitor breathing and physical activity. These biosensors are designed for specific applications, enabling a wide range of health-related uses. Unlike traditional diagnostics, wearable biosensors facilitate real-time health tracking and are often connected to smartphones or cloud platforms for seamless data visualisation and analysis. Their portability enables users to monitor their health anytime and anywhere, reducing dependency on clinical settings and empowering individuals with actionable insights. These systems have become crucial in managing chronic diseases, supporting preventive care, and enhancing personalised medicine. As flexible materials, miniaturised electronics, and AI-driven analytics continue to evolve, wearable biosensors are transitioning from simple health trackers to essential tools in next-generation healthcare. One of the most well-known examples of biosensors in the medical field is the use of glucose biosensors in diabetes management. At-home blood glucose biosensors to monitor blood-glucose account for around 85% of the global biosensor market. Continuous glucose monitors, such as the FreeStyle Libre and Dexcom G6, use interstitial fluid to deliver real-time glucose readings. Worn on the upper arm or abdomen, these sensors empower individuals to make informed decisions about insulin administration and diet, significantly reducing the risks associated with hypoglycaemia and hyperglycaemia. Wearable biosensors are also powerful tools for fertility and maternity monitoring, cancer diagnostics, and infectious disease detection. For example, fluorescent biosensors, including genetically encoded FRET sensors, are used in oncology to monitor intracellular enzyme activity associated with tumour metabolism and drug response. These insights guide personalised cancer therapy and drug efficacy evaluations. Additionally, ECG wearables enable early detection of arrhythmias and irregular heart patterns, improving patient outcomes through timely interventions and reduced healthcare costs. The diagnostic capabilities of wearable biosensors extend beyond non-clinical environments , allowing for point-of-care testing and at-home diagnostics. These compact, portable devices generate rapid results and are increasingly integrated into telemedicine platforms, enabling healthcare providers to remotely monitor patients, particularly in elderly care or rural settings. Their quick output facilitates immediate treatment decisions, leading to faster interventions and improved patient outcomes. Recent innovations include biosensors that diagnose urinary tract infections (UTIs) by identifying pathogens and determining antibiotic susceptibility without centralised lab processing. Additionally, devices like Epicore Biosystems’ Discover Patch, collect and analyse sweat to monitor hydration and electrolyte levels during physical activity. Wearables also play an important role in implantable devices, such as bioelectric implants and prosthetics. While more invasive, these devices can detect specific biomarkers of physiological signals, providing essential information to healthcare professionals. For example, Biospectal’s optical blood pressure monitor offers non-invasive blood pressure tracking from the fingertip, which could benefit over 120 million Americans living with hypertension. In sports and fitness, wearable biosensors offer athletes and fitness enthusiasts detailed physiological data that can inform training regimes, prevent injuries, and optimise recovery. Devices embedded with inertial sensors and gyroscopes assess biomechanics , such as stride and joint angles, enhancing performance while minimising strain for runners and cyclists. These wearables also monitor sleep patterns, heart rate variability, and recovery indicators to help users manage exertion and avoid overtraining. Such insights not only refine athletic technique but also promote long-term physical wellness. Beyond healthcare and fitness aspects, wearable biosensors are transforming personal wellness and preventive health. Devices equipped with electrodermal activity (EDA) sensors and temperature monitors track stress and sleep quality, offering personalised recommendations. This influences decision making to make healthier lifestyle choices that may lead to improved wellness. By analysing heart rate, physical activity, and sleep disruptions, users receive tailored feedback to manage stress and enhance overall well-being. These tools support proactive health management and long-term behaviour change. For example, by monitoring sleep time, stages, and sleep disruptions, it provides suggestions for individuals, along with sleep solutions to improve the quality of their sleep. The advantages of wearable biosensors are extensive , with their most compelling benefit being the ability to monitor health anytime and anywhere. They provide pain-free, real-time insights into biomarkers using accessible biofluids, eliminating the need for invasive procedures. Continuous monitoring enables early detection of health abnormalities and supports personalised treatments based on dynamic data rather than reactive symptom management. One of their key strengths is early detection and personalised management of chronic diseases by tracking multiple physiological variables, such as glucose levels, hydration, temperature, cardiac activity, and biomarkers of inflammation or infection. This continuous data stream supports precision medicine by allowing treatments to be tailored based on molecular-level insights rather than solely observable symptoms. Miniaturised sensors provide real-time analysis of molecular markers through easily measurable parameters such as temperature, dehydration, or glucose levels. Wearable biosensors also facilitate direct communication between users and healthcare providers, reduce hospital visits, and lower healthcare costs by replacing bulky traditional diagnostic equipment with compact alternatives. In clinical contexts, they minimise the need for prolonged hospital stays and repetitive testing, particularly for chronic disease management. Their cost-effectiveness and portability ease the burden on healthcare systems by optimising resource allocation, in contrast to traditional equipment like ECG monitors and defibrillators, helping healthcare systems reduce resource strain. Furthermore, wearable biosensors enhance public health by enabling early detection of outbreaks, such as COVID-19 and SARS, through continuous symptoms and vital sign tracking. Their applications in cardiovascular monitoring are particularly impactful, as cardiovascular disease remains the leading cause of death globally, claiming over 17 million lives annually. Highly sensitive biosensors using nanomaterials and advanced chemistries enable rapid and accurate diagnostics at the point of care. In rehabilitation and physical therapy, these devices monitor joint motion and strain, supporting injury recovery and informing therapeutic strategies. Despite their promise, wearable biosensors face several challenges. Ensuring sensor accuracy and stability, especially in non-invasive systems, requires precise calibration and stable skin contact. Other challenges include bioreceptor fragility, susceptibility to biofouling, and inefficient analyte transport, all of which affect signal reliability. Researchers are addressing these issues with antifouling coatings, multimodal sensing, and integrated calibration systems. Wireless communication also presents limitations, as devices must balance short-range protocols with the need for remote data transmission. Power supply remains another major concern, with continuous operation demanding efficient, long-lasting energy sources such as wearable batteries, energy harvesting systems, and smart power management strategies. Meeting these power requirements in a safe manner requires various approaches such as using safe high-energy wearable batteries, wireless energy transfer, alternative energy storage devices (biofuel/ solar cell), or even self-powered biosensors using biofuel cells. Whilst real-time monitoring is a key benefit, data privacy and security are fundamental. Sensitive health data must be protected from unauthorised access and misuse. Some approaches involve data cleaning and filtering processes to safeguard information while maintaining seamless connectivity. Looking ahead, the innovation of wearable biosensors will continue to expand and promote widespread adoption. Non-invasive monitoring using sweat, saliva, and interstitial fluid will become increasingly common, enabling painless health tracking across a wide range of biomarkers. Integration with artificial intelligence (AI) and machine learning will help develop predictive capabilities, reduce false readings, and personalise feedback based on user behaviour . Remote patient monitoring will become more prevalent, especially in telehealth, supporting chronic disease management and reducing hospital dependence. Miniaturisation and portability will continue to improve with the development of lab-on-a-chip technologies and smartphone integration, facilitating real-time health insights and cloud-based analytics. Internet of Things (IoT) connectivity will link biosensors to broader healthcare ecosystems, enabling predictive and preventive care at scale. As biosensor platforms grow more sophisticated utilising DNA-based, optical, and electrochemical technologies, healthcare will shift toward more proactive and personalised models. In summary, wearable biosensors are revolutionising healthcare, wellness, and performance monitoring. Their ability to provide continuous, real-time, and non-invasive data makes them invaluable tools for early diagnosis, personalised treatment, chronic disease management, and lifestyle optimisation. While challenges remain regarding technology, cost, and regulation, ongoing advancements in AI, materials science, and digital health infrastructure position wearable biosensors as a cornerstone of future healthcare delivery. Author Amrithavarshini Omprakash , freelance contributor Previous Next