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< Back A New Device Could Improve How Progesterone is Delivered in Early Pregnancy A first-in-human trial for a tampon-like intravaginal drug delivery platform arrives at a moment when England's newly published Women's Health Strategy is calling for exactly this kind of patient-centred innovation. Miscarriage is one of the most common pregnancy complications in the UK, and also one of the least talked about. It is estimated that between 120,000 and 250,000 miscarriages occur each year in the country, a range that already signals how poorly captured this data remains. Against that backdrop, a London-based medical technology company has reached an important milestone: the first patients have been dosed in a clinical trial evaluating a new intravaginal drug delivery platform designed to administer progesterone more reliably in women at risk of pregnancy loss. Calla Lily Clinical Care announced on 6 May 2026 that its FREEDOM study, a first-in-human safety and usability trial, had begun enrolling patients at University Hospitals Coventry and Warwickshire NHS Trust. The trial is funded by the National Institute for Health and Care Research (NIHR) and will evaluate the company's Callavid device in women diagnosed with luteal phase insufficiency: a condition in which the body produces insufficient progesterone during the second half of the menstrual cycle to sustain early pregnancy, increasing the risk of infertility and recurrent miscarriage. What is the problem with existing progesterone delivery? Progesterone supplementation in early pregnancy is not new. Administering 400mg micronised progesterone twice daily is recommended by NICE for women who have suffered a previous miscarriage and experience bleeding in early pregnancy, clinically termed threatened miscarriage. However, current delivery relies on vaginal pessaries, suppository-style products that, as any patient using them knows, are far from ideal. They can leak, their placement during use is uncertain, and women are routinely advised to lie horizontally for extended periods following each administration. These aren't trivial inconveniences. Unreliable placement means uncertain drug absorption, which raises genuine questions about whether the intended therapeutic dose is actually being delivered at the moments it matters most. Calla Lily argues that its Callavid device, described as tampon-like in form, with a patented leak-free design, directly addresses these shortcomings, enabling more consistent intravaginal drug delivery with better user experience. If that holds up under clinical scrutiny, it would represent a genuine improvement in care for a patient population navigating an already stressful period. The FREEDOM study - which stands for F i R st in human saf E ty and E ase of use assessment of 400mg progesterone Callavi D in w OM en with luteal phase insufficiency - is designed to assess safety, user acceptability, and progesterone absorption, building the evidential foundation regulators will require before any wider deployment. What do the trial investigators say? Professor Siobhan Quenby MBE, a world-leading authority on miscarriage and preterm birth who serves as Chief Investigator of the FREEDOM trial, offered a clear-eyed view of the clinical gap Callavid is intended to fill. "Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment." The company's co-founder and chair, Dr Lara Zibners, brings a perspective that goes beyond the clinical. "As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centred solutions in women's health. Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience." How does this connect to England's Women's Health Strategy 2026? The Renewed Women's Health Strategy for England was recently published in April 2026. It is forthright about the scale of the problem it is attempting to address. The Secretary of State for Health and Social Care opens the document with a frank admission that the NHS has a problem with medical misogyny, citing women being ignored, gaslit, and disrespected as experiences shared by more than eight in ten women when engaging with healthcare professionals. The strategy explicitly prioritises improving support for fertility and pregnancy loss, and commits to reviewing the evidence for rolling out a graded model of care for repeated pregnancy loss. More broadly, the strategy positions women's health innovation as central to its ambitions. The NIHR R&D Innovation Catalyst, launched this year, is intended to provide funding and wrap-around support for high-priority innovations, explicitly including those in reproductive health. Within two years, the government also plans to launch a FemTech healthcare challenge with a £1.5 million funding pot, aimed at developers addressing areas of unmet clinical need, with a focus on community service models and health inequalities. A device like Callavid which targets a specific, well-documented gap in a high-need area, backed by NIHR funding, and developed with patient experience at its centre, is precisely the kind of innovation that framework is designed to support. Whether it will ultimately benefit from such mechanisms depends on what the FREEDOM trial data shows. Reproductive health innovation in a broader moment The Calla Lily announcement sits within a period of genuine, if uneven, progress in women's reproductive health innovation. At BioFocus, we've covered related developments that are worth placing alongside this one. We reported on research published in The BMJ demonstrating that menstrual blood collected on a modified sanitary pad could detect HPV with comparable accuracy to clinician-collected cervical samples, a finding with significant implications for cervical cancer screening access, particularly among women who avoid clinic-based procedures. And in a broader analysis of cross-sector collaboration, we examined the systemic barriers that continue to prevent cervical cancer elimination from becoming a reality, despite the tools to achieve it already existing. These are not unrelated stories. They share a common thread of healthcare systems not designed around women's bodies or women's lives, and the slow, often incremental work of addressing that deficit through innovation, policy, and a growing determination, at both industry and government level, to close the gap. What are the limitations and what comes next? Callavid has not yet demonstrated anything beyond safety and usability in this initial human trial. The FREEDOM study is an early-phase assessment, and the path from first-in-human data to an approved product that reaches patients at scale is long and uncertain. CEO Thang Vo-Ta was candid about where the company sees the device's potential: "Callavid represents a differentiated delivery modality for a broad range of therapeutics in the pharma pipeline, and will create new opportunities to extend the lifecycle of existing drugs. This trial is a key step in demonstrating Callavid's massive potential." That language signals a commercial pipeline that extends well beyond miscarriage, which is a reasonable ambition for a drug-device combination platform if the underlying delivery technology proves out. For context , the average time from first seeing a doctor with symptoms to an official endometriosis diagnosis in the UK is around nine years and four months. It is a useful reminder of how far intention and evidence-gathering remain from patient impact in women's health. But it is also precisely because that gap has been so persistent and so consequential that early-stage trials like FREEDOM deserve attention. Author BioFocus Newsroom Previous Next

The futuristic visions of Mars we see on our movie screens could be closer than we think - but what’s the biology that would make it a reality? < Back Life on Mars - Science Fiction, or Real-Life Science? The futuristic visions of Mars we see on our movie screens could be closer than we think - but what’s the biology that would make it a reality? The concept of life on the Red Planet has long captured the interest of scientists and filmmakers alike, and with new discoveries and groundbreaking expeditions, this future may no longer just be a thing of fiction. Yet, beyond space discovery, biology would be the backbone for truly bringing this planet to life. So this poses the question: what science would it take for life to really be possible on Mars? Offering insight into this is NASA’s Perseverance rover , a crucial tool in the Mars Exploration Programme that’s examining life from land to water, addressing whether Mars craters have hosted life before - and whether they could again. Key biosignatures recorded by Perseverance - namely from the Martian rock Sapphire Canyon - have recently been studied and have suggested habitable conditions on one of Mars’ most promising and insightful craters, Jezero. This article aims to dissect Perseverance’s findings through the lens of the key earth systems - land, water and air - to assess the true potential for life on Mars in an interconnected way. A solid start The lithosphere encompasses the fundamental geological requirements for a liveable planet, providing fundamental habitats, essential chemical resources, and partaking in crucial ancient rock-water interactions, providing the backbone for water cycles and fundamental water bodies. Twenty-four diverse minerals have been identified in the Jezoro crater, characterised by their volcanic origin, but also their interactions with water. Perseverance’s x-ray features enabled the creation of a mineralogical archive, and these minerals revealed details of those key water-rock interactions. The older rocks studied closer to the crater floor bore signs of harsh, hot, acidic liquid interactions - while this doesn’t rule out possible habitability, these conditions are harsh and unfavourable, making it more unlikely. When looking at more neutral and cool waters, completely different possibilities are revealed. Possibilities are flowing The hydrosphere is another earth system fundamental for planet habitability, going beyond meeting the individual metabolic and nutrient requirements for any living organisms it hosts, but also playing crucial roles in regulating temperatures and weather through complex interactions with the atmosphere. Continuing to look at the Jezoro craters’ multiple episodes of water activity, more cooler, neutral waters in later episodes left behind further insightful minerals. While direct biological evidence is still absent, these conditions could be interpreted as more microbe friendly, increasing the chances for the flourishing of life within the crater. While the intricate interactions between the lithosphere and hydrosphere have been covered, one can’t speculate over life on Mars without taking into account the other entire life systems which play a fundamental role in not only supporting life, but allowing it to flourish. There must be something in the air Despite past interactions revealing that the geology and water on Mars once exhibited favourable conditions for life, the potential for life on Mars cannot be theorised comprehensively without looking at the atmosphere enveloping it all. Providing not only gases that sustain biological life, but working with both the litho- and the hydrosphere in order to regulate temperature, the climate and weather, the atmosphere is a key backbone for not just the complexity of life, but the existence of life at all. On Earth, the atmosphere is able to successfully sustain an abundant Earth biosphere due to its gas composition of primarily nitrogen - the key component for life’s complex proteins, DNAs and RNAs - followed by oxygen vital for respiration and combustion. Contrastingly, the thin and comparatively weaker Mars atmosphere, composed of predominantly carbon dioxide, lacks the ability to provide a stable habitat due to its periods of extreme freezing, leading to an inability for water to flow freely on the planet. To conclude After compiling the fascinating evidence of the elements currently on Mars, and comparing these to the speculated optimal conditions that would sustain life there, it’s safe to say that fully functioning Martian societies may be confined to our favourite sci-fi books and films for the time being. However, this is nothing to be disheartened by - paying attention to just how fine tuned the systems that enable planetary health are could influence how we look after the planet we are lucky enough to inhabit now. All of the processes discussed through this article that would need to be kept within set ranges to enable life on Mars, from the gases that keep us breathing and the systems that control the weather, also need to be kept within set ranges on Earth. While we may not be expanding our livable universe to Mars just yet, the Red Planet can serve as a symbol of how delicate and worthy-of-preserving our own Earth is. Author Monica Bhatia , freelance contributor Previous Next

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CN Bio has launched new PhysioMimix® computational modeling tools to strengthen ADME profiling, improve bioavailability predictions, and accelerate drug discovery workflows. < Back CN Bio Expands ADME Services with Computational Modeling Tools to Advance Drug Discovery CN Bio has launched new PhysioMimix® computational modeling tools to strengthen ADME profiling, improve bioavailability predictions, and accelerate drug discovery workflows. CN Bio, a global leader in organ-on-a-chip (OOC) systems, has unveiled new computational modeling tools designed to enhance bioavailability profiling and strengthen in vitro to in vivo extrapolation (IVIVE) for drug development. The company’s new PhysioMimix® in silico capabilities integrate mathematical modeling with insights from microphysiological system (MPS) assays, offering drug developers deeper functional understanding of a compound’s absorption, distribution, metabolism, and excretion (ADME) profile. Available through CN Bio’s Contract Research Services (CRS) or as standalone kits, these tools complement its proprietary dual-organ Gut/Liver bioavailability assay. The new computational models are fully compatible with physiologically based pharmacokinetic (PBPK) frameworks, enabling more accurate predictions of how compounds behave in the human body while extracting additional value from preclinical data. Dr. Yassen Abbas, Lead Scientist at CN Bio, highlighted the regulatory momentum driving innovation: “This year, the FDA made significant changes to phase out animal testing requirements, signaling a clear shift toward more relevant human approaches for preclinical safety and toxicity testing,” Abbas said. “By integrating advanced in silico modeling into our offering, we’re helping customers bridge the gap between in vitro data and in vivo translation, providing tools to design safer, more effective therapies.” The updated CRS offering provides end-to-end support for clients, from study design to data interpretation. CN Bio’s team of MPS and computational modeling specialists collaborate closely with customers to ensure high-quality experimental outputs and clear, decision-ready insights to inform drug dosing and go/no-go decisions. This launch follows CN Bio’s 2024 introduction of its bioavailability assay, marking another step toward modernizing preclinical workflows as the pharmaceutical industry moves away from traditional animal testing. Author BioFocus Newsroom Previous Next

Collaboration aims to develop species-specific binders to accelerate research and improve control of zoonotic diseases. < Back ProImmune and Roslin Institute Partner to Expand Tools for Veterinary Immunology Collaboration aims to develop species-specific binders to accelerate research and improve control of zoonotic diseases. ProImmune Ltd has announced a new collaboration with the Roslin Institute to advance veterinary immunology through the development of novel, species-specific binding reagents. The partnership will focus on generating and validating Ankyron® binders , small, high-specificity proteins designed to target key immune system components across a range of animal species. The initiative is expected to address a longstanding bottleneck in animal health research: the limited availability of high-quality, species-specific reagents. Addressing Gaps in Veterinary Research Tools Despite growing recognition of the importance of animal health in global disease prevention, veterinary immunology has historically lagged behind human-focused research due to a lack of reliable tools. Under the agreement, researchers at the Roslin Institute will identify priority protein targets, particularly where suitable reagents do not yet exist. ProImmune will then use its proprietary platform to generate highly specific Ankyron binders against targets in porcine, bovine, avian, and salmonid species. These reagents will support a range of applications, including flow cytometry and immunofluorescence imaging, enabling more detailed analysis of immune responses across species. Leveraging Ankyron Technology Ankyrons are small (~15 kDa) binding proteins identified through ProImmune’s high-throughput, in vitro screening platform. Their size and specificity allow for rapid and cost-effective discovery compared to traditional antibody-based approaches, particularly in species where antibody availability is limited. By expanding access to such reagents, the collaboration aims to unlock new areas of research and improve experimental reproducibility across veterinary and comparative immunology. Supporting a Global Research Community Validated data generated through the collaboration will be made available via the Immunological Toolbox, a Biotechnology and Biological Sciences Research Council (BBSRC)-funded initiative led by the Roslin and Pirbright Institutes. The platform is designed to provide researchers with easy access to high-quality immunological reagents, helping to standardise tools and streamline workflows across the field. Advancing One Health Priorities The collaboration also aligns with the World Health Organization’s One Health framework, which recognises the interconnected nature of human, animal, and environmental health. By improving the ability to study immune responses in animals, the partnership is expected to support efforts to monitor and control zoonotic diseases, those that can be transmitted between animals and humans, as well as contribute to more sustainable farming practices and enhanced food security. Professor Jayne Hope of the Roslin Institute highlighted the impact of the technology, noting that improved reagent availability could help address longstanding gaps in veterinary immunology research. Dr. Nikolai Schwabe, CEO of ProImmune, added that the collaboration represents a step toward developing tools that support both animal and human health, reinforcing the importance of integrated approaches to global health challenges. As interest in zoonotic disease prevention and animal health continues to grow, initiatives that expand the research toolkit are likely to play a critical role in accelerating discovery. By combining ProImmune’s binding technology with the Roslin Institute’s expertise in animal health, the collaboration aims to deliver practical solutions that enable new scientific insights and ultimately, more effective strategies for disease prevention and control. Author BioFocus Newsroom Previous Next

New validated protocols on SPT’s firefly platform aim to boost throughput and reproducibility for sequencing labs. < Back SPT Labtech and Twist Bioscience Team-up to Automate NGS Library Prep Workflows New validated protocols on SPT’s firefly platform aim to boost throughput and reproducibility for sequencing labs. SPT Labtech has rolled out new automated workflows for Twist Bioscience’s next-generation sequencing (NGS) library preparation kits on its firefly liquid handling platform, aiming to boost throughput and consistency for genomics laboratories. Developed in collaboration with Twist , the validated methods are accessible via the Firefly Cloud and support Twist’s FlexPrep UHT Library Preparation Kit as well as the company’s Enzymatic Fragmentation Kit 2.0. According to SPT Labtech , the workflows address growing demand from research and core facilities for standardised, hands-free NGS protocols as sequencing volumes continue to scale. The automated FlexPrep workflow integrates on-deck fragmentation and ligation, alongside an auto-normalising protocol that consolidates indexing and final clean-up into four columns of a 96-well plate. The company says this supports higher throughput without requiring access to 384-well thermal cyclers, while also improving reproducibility across samples. In parallel, the integration of Twist’s Enzymatic Fragmentation Kit 2.0 with firefly is intended to offer an efficient sequencing pipeline with reduced error rates and more accurate readouts. SPT Labtech expects ongoing combinations of Twist kits with firefly to expand its catalogue of validated, ready-to-deploy automated workflows. Rob Walton, Chief Executive Officer at SPT Labtech, said: “We are delighted to be working with Twist Bioscience to bring these high-demand methods to our customers. By making these Twist workflows available on Firefly, we are giving users a straightforward way to adopt automation without adding complexity to their existing processes, while access through the Firefly cloud allows laboratories to implement these methods quickly and scale as their needs evolve.” Emily Leproust, Chief Executive Officer and Co-founder of Twist Bioscience, added: “Our customers are increasingly seeking validated, hands-free solutions to improve the efficiency and reproducibility of their NGS workflows. By collaborating with SPT Labtech, we are providing a simple path to automation for our kits, beginning with our new FlexPrep kit, which offers significant benefits in terms of speed and scalability." The workflows are available immediately to Firefly users via the Firefly Cloud. The collaboration reflects a broader trend towards workflow simplification and automation in sequencing, driven by mounting sample volumes and tightening turnaround expectations across research and clinical settings. As libraries become faster and more consistent to prepare, bottlenecks increasingly shift upstream or downstream of sequencing itself. By validating Twist’s kits on firefly and making the methods instantly accessible through the cloud, SPT Labtech is positioning automation as a turnkey choice rather than a complex engineering project. 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

Promising early data at CROI 2025 shows that HIV functional cure candidate, IMC-M113V, is well-tolerated and may offer prolonged viral suppression without the need for lifelong antiretroviral therapy. < Back Immunocore Unveils Promising HIV Functional Cure Data at CROI 2025 Promising early data at CROI 2025 shows that HIV functional cure candidate, IMC-M113V, is well-tolerated and may offer prolonged viral suppression without the need for lifelong antiretroviral therapy. Immunocore is a leading biotechnology company focused on developing cutting-edge therapies that harness the power of the immune system to treat a variety of cancers and infectious diseases. The company’s proprietary ImmTAC platform enables the development of novel immunotherapies that can target and destroy diseased cells with precision. Immunocore’s portfolio includes therapies for both oncology and infectious diseases, with a strong commitment to transforming the treatment landscape for patients worldwide. Immunocore Holdings plc (IMCR), a leader in immuno-oncology, has revealed groundbreaking early-stage data from its Phase 1/2 STRIVE trial of IMC-M113V, a novel candidate aimed at providing a functional cure for HIV. The data were presented in an oral session at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI). The multiple ascending dose (MAD) phase of the trial showed promising results, indicating that IMC-M113V is well-tolerated and capable of inducing dose-dependent viral control in HIV patients. These findings come as a major step forward in the ongoing quest to develop a treatment that could eliminate the need for lifelong antiretroviral therapy (ART). Notably, some patients demonstrated viral suppression lasting for up to 12 weeks after ART interruption, providing early evidence of the potential for long-term control. IMC-M113V, Immunocore’s most advanced HIV candidate, targets the virus in a unique manner, leveraging the company’s proprietary ImmTAC technology to activate the immune system’s T cells to target and destroy HIV-infected cells. The STRIVE trial is designed to evaluate the safety, tolerability, and efficacy of IMC-M113V at escalating doses, and these initial findings mark an important milestone in the development of a functional cure for HIV. “We are excited to share the early results from the STRIVE trial, which represent an important step toward potentially transforming the treatment landscape for people living with HIV,” said Dr. Anna Taylor, Chief Medical Officer at Immunocore. “While these data are still in the early stages, the ability of IMC-M113V to provide prolonged viral suppression without the need for ART is encouraging, and we look forward to continuing to explore its potential in future trial stages.” Immunocore emphasized that while the data is still in its early phase, the results suggest the potential of IMC-M113V to be a game-changer in the fight against HIV, offering hope for a functional cure that could reduce or eliminate the dependency on daily ART regimens. The company is continuing to test higher doses of IMC-M113V in the ongoing trial, with further data expected in the coming months. Researchers and clinicians alike are watching closely to see how these findings progress, as the development of a functional cure for HIV remains one of the most sought-after goals in the field of infectious disease. Author BioFocus Newsroom Previous Next

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Read the essential strategies and considerations for scaling up biologics and our run down of the top 10 companies supporting biologic scale up. < Back Essential Strategies for Scaling Up Biologics Read the essential strategies and considerations for scaling up biologics and our run down of the top 10 companies supporting biologic scale up. Biologics are revolutionising healthcare. Characterised as pharmaceutical drugs that are produced from biological systems, biologics such as therapeutic proteins, monoclonal antibodies (mAbs), and vaccines are providing highly targeted and effective treatments for conditions where patients have historically had few effective options. Recent research by Nova One Adviser values the global biologics market at $511 billion, projected to reach $1,375 billion by 2033. The ability for biopharma companies to efficiently scale the manufacturing of this type of therapeutic is paramount to realising this market value. Predictably though, scaling up is complex, and requires the implementation of critical strategies and considerations to ensure the process is efficient, cost-effective, and compliant with regulatory standards. Here, we take a look at the essential strategies for biologic scale-up, and provide a run-down of the top 10 premier companies specialising in biologic scale-up solutions. Scale up strategies and considerations Process development and optimisation A critical step in scale up is developing and refining media and feed strategies to maximize yield, titers, and cell density. It is also important to consider how the media and feed strategy translates to large-scale bioreactors. Ensuring bioreactor processes can maintain consistency from lab to pilot and production scales is imperative to achieving succesful scale up. Using optimized cell lines to enhance productivity and product quality is vital to ensure successful scale up. Cell lines are cultures of animal cells that can be propagated repeatedly, and in some cases indefinitely. Mammalian systems have higher levels of native folding, post-translational modifications, and more functional activity than other systems meaning they are more closely representative of a physiologically relevant environment for producing proteins for human use. Chinese hamster ovary cells (CHO) are the gold standard for protein production due to high productivity, the ability to allow for post-translational modifications, and low virus susceptibility. Additionally, they can grow in serum-free and chemically defined media, which helps ensure reproducibility between different batches, and they can also easily grow in large-scale cell culture. Quality control and assurance Developing robust analytical methods to ensure product quality and consistency, and ensuring all processes comply with regulatory requirements, including Good Manufacturing Practice (GMP) standards is paramount. Validation processes should be conducted to demonstrate that the process consistently produces a product meeting its predetermined specifications and quality attributes. Technology transfer It is important to have a thorough, well-planned technology transfer program that features detailed product information, process-related documentation, material transfer agreements, facility fit assessments, training requirements, and regulatory considerations. This will help protect against unwanted surprises and instead facilitate a seamless transfer between development and manufacturing stages. Scale-Up equipment and infrastructure Deciding between single-use bioreactors and traditional stainless steel systems is a key decision that biopharmaceutical manufacturers must make. The decision involves a myriad of different factors that should be considered across areas such as sustainability, flexibility, scale, quality, and cost/speed. In recent times, single-use technologies (SUT) has become more widely adopted, contributing to increasing process intensification due to SUT’s advantage of being more flexible, cost-effective, sustainable, and possessing lower risk of cross-contamination when compared to more traditional stainless steel systems. An additional consideration for equipment and infrastructure is the implementation of automation and advanced control systems in order to maintain optimal and harmonized conditions during production. Real-time monitoring of the bioprocessing workflow allows for precise control of process parameters, which is critical for success. Supply chain management Reliable sourcing of high-quality raw materials is a vital component of scaling up because any impurities in the raw materials, when scaling up to large bioreactors, can be amplified, in doing so influencing performance parameters and causing lot-to-lot inconsistencies. It is important when choosing a manufacturing supplier to ensure they have global redundancy in manufacturing supply as pauses in the manufacturing process are highly costly. In recent times, the unprecedented demand for bioproduction materials, combined with significant disruption to global supply chains, has placed an increasing importance on ensuring a robust raw material supply to meet timelines and avoid costly delays. Risk management Developing contingency plans for potential risks, such as equipment failure or supply chain disruptions is crucial as is the use of scale-down models to identify and mitigate risks before full-scale production The Top 10 Companies Supporting Biologic Scale-Up Lonza Lonza has a strong reputation in the industry. It offers comprehensive biologics development and manufacturing services, including cell line development; process development; commercial manufacturing; mammalian and microbial production; cell and gene therapy manufacturing, drug production services including formulation, fill and finish. Thermo Fisher Scientific With an extensive global footprint, Thermo Fisher Scientific provides comprehensive services for biologics development and manufacturing, including cell line development, process optimisation, cell culture media, bioreactors, purification systems, fill/finish, analytical testing services, and large-scale production. WuXi AppTec WuXi AppTec provides end-to-end solutions for biologics development, including cell line development, process optimisation, GMP manufacturing, and analytical development services. It has a strong global presence, rapid turnaround times, and extensive capabilities in cell and gene therapies. Samsung Biologics A relatively new player compared to others, Samsung Biologics offers a full-service CDMO for biologics, with process, development, clinical and commercial manufacturing services, as well as drug product services including aseptic fill/finish and lyophilization. Fujifilm Diosynth Biotechnologies Located in the United States and Europe, Fujifilm Diosynth Biotechnologies specialises in the development and manufacturing of biologics, with expertise in process development, analytical development, and GMP manufacturing. Catalent Biologics With a focus on speed and flexibility, Catalent Biologics offers integrated biologics development and manufacturing solutions, including cell line development, process development, fill/finish, packaging, clinical supply services, analytical services, and commercial manufacturing. Boehringer Ingelheim BioXcellence Boehringer Ingelheim BioXcellence has a long history of experience in biopharmaceutical manufacturing. It provides a comprehensive, premium service offering for biologics manufacturing. Millipore Sigma With strong expertise in bioprocessing technologies and a focus on innovation, Millipore Sigma services include cell culture media, filtration, purification systems, analytical testing and validation, and manufacturing services. Cytiva Cytiva has a strong legacy in bioprocessing and an extensive product and technology service offering. This includes cell culture, filtration, and purification solutions as well as automation and digital solutions for biomanufacturing. Sartorius Sartorious is one of the leading providers of single-use bioprocessing technologies and has a strong focus on innovation and process efficiency. It has a comprehensive product portfolio for biologic manufacturing Conclusion Scaling up the production of a biologic requires many considerations and optimization strategies. Choosing the right company to partner with can significantly streamline this process, ensuring the biologic is produced efficiently and meets regulatory standards. Author BioFocus Newsroom Previous Next

Phase 3 data show modest efficacy for Lilly's once-daily oral GLP-1, positioning it as a convenient but less potent rival to injectable obesity drugs. < Back Eli Lilly's Oral GLP-1 Candidate Orforglipron Shows 12% Weight Loss in Pivotal Trial, Eyes Regulatory Filing Phase 3 data show modest efficacy for Lilly's once-daily oral GLP-1, positioning it as a convenient but less potent rival to injectable obesity drugs. Eli Lilly’s experimental oral GLP-1 receptor agonist, orforglipron, has delivered up to 12.4% mean weight loss in a late-stage obesity trial, setting the stage for a regulatory submission by the end of 2025. While the results may not match the dramatic efficacy of injectable GLP-1 drugs, Lilly is positioning the once-daily pill as a more convenient, potentially lower-cost alternative in the rapidly expanding obesity market. Attain-1: 3,100+ patients, three doses, clear dose-response The phase 3 Attain-1 study enrolled 3,127 adults with obesity or overweight who had at least one weight-related comorbidity, such as hypertension or cardiovascular disease, but without diabetes. Participants were randomised to receive 6 mg, 12 mg, or 36 mg of orforglipron once daily, or placebo, for 72 weeks. All began at 1 mg/day, escalating every four weeks to their assigned maintenance dose. At the highest 36 mg dose, participants achieved a mean 12.4% weight loss, equivalent to 27.3 pounds, compared with 0.9% (2.2 pounds) in the placebo arm. The 12 mg and 6 mg groups lost 9.3% (20.7 pounds) and 7.8% (17.6 pounds), respectively. Secondary endpoints reinforced the dose-response pattern: nearly 60% of high-dose patients lost ≥10% of body weight, and ~40% lost ≥15%. Cardiometabolic signals and inflammation reduction Lilly also highlighted pooled analysis data showing reductions in non-HDL cholesterol, triglycerides, and systolic blood pressure across all orforglipron arms. In a prespecified exploratory analysis, the highest dose reduced high-sensitivity C-reactive protein, a marker of systemic inflammation, by nearly 48%, suggesting potential cardiovascular risk benefits. Safety profile in line with GLP-1 class, but some caveats As with other GLP-1 agents, the most common adverse events were gastrointestinal (nausea, vomiting, diarrhoea). No liver safety signals emerged. Discontinuation due to adverse events ranged from 5.1% to 10.3% across doses, versus 2.6% for placebo, but total discontinuation rates were actually lower in active arms than in placebo. Notably, William Blair analysts flagged that GI side effects appeared to persist beyond the titration phase, unlike in some peptide-based GLP-1s. Market context: convenience vs. efficacy gap While Lilly executives touted the data as “as good as it gets” for a once-daily small-molecule GLP-1, the efficacy lags behind injectable rivals. Lilly’s own tirzepatide (Zepbound) has delivered >20% mean weight loss in non-diabetic patients, and Novo Nordisk’s investigational high-dose semaglutide (7.2 mg) has hit ~21% over a similar period. For some patients, an oral therapy could be an attractive option, sidestepping injections and potentially lowering cost. In the UK, for instance, orforglipron could represent a simpler alternative for the NHS compared to injectable obesity medicines. But for those chasing maximal weight loss, injectables may retain the edge. Competitive pressures and shifting obesity pipelines Lilly’s data drop comes amid turbulence in the obesity R&D landscape. Novo Nordisk recently discontinued multiple obesity candidates, including a GLP-1/GIP co-agonist and a CB1 receptor blocker, following underwhelming results. Pfizer has similarly exited the GLP-1 race after setbacks in its own oral programs. Yet, competition remains fierce. Viking Therapeutics and Structure Therapeutics, both developing oral metabolic agents, could see investor interest following Lilly’s slight miss against Wall Street efficacy forecasts. Next steps Lilly plans to present full Attain-1 data at the 2025 European Association for the Study of Diabetes (EASD) Annual Meeting and in a peer-reviewed journal. A second pivotal study, Attain-2, is ongoing, with results expected later this year. Together, the Attain trials form part of the broader seven-study Achieve program, which also includes trials in type 2 diabetes populations. If approved, orforglipron could mark the first widely available oral GLP-1 therapy for obesity, a category still dominated by injectables, and reshape patient access strategies in a market projected to exceed $100 billion annually by the early 2030s. Author BioFocus Newsroom Previous Next

Investor skepticism underscores challenges in demonstrating robust clinical value in psychedelic therapeutics for depression. < Back Compass Pathways' Phase 3 Psilocybin Readout Raises Efficacy Questions Despite Meeting Primary Endpoint Investor skepticism underscores challenges in demonstrating robust clinical value in psychedelic therapeutics for depression. In a long-anticipated clinical milestone for the psychedelics space, Compass Pathways reported topline results from a pivotal Phase 3 study of its proprietary psilocybin formulation, COMP360, in treatment-resistant depression (TRD). While the study met its primary endpoint, the magnitude of benefit and lack of detailed secondary outcomes left markets underwhelmed, sending shares tumbling by nearly 50% in early trading . The U.K.-based biotech enrolled 258 TRD patients, administering a single dose of COMP360 or placebo in a double-blind design, followed by psychological support. At six weeks, the psilocybin arm demonstrated a statistically significant 3.6-point reduction on the MADRS scale relative to placebo, a result Compass positioned as both clinically meaningful and a validation of its development approach. However, in an environment of growing competition and increasing investor scrutiny, the response was tepid. Analysts and key opinion leaders flagged the relatively modest separation from placebo, particularly in contrast to earlier Phase 2 data showing approximately a 6-point difference, and noted the absence of crucial secondary metrics such as remission and response rates. RBC Capital Markets analyst Leonid Timashev noted that in the absence of durability data or functional endpoints, a 3.6-point delta on MADRS may not be enough to drive investor confidence or payer differentiation. Futhermore, clinicians in their outreach indicated that a 4-point margin would be a minimum threshold of interest, with 5 points or more seen as indicative of a compelling treatment effect. This tempered enthusiasm may also reflect expectations shaped by recent competitors. GH Research, for example, reported promising results in an 81-patient trial of inhaled mebufotenin, a psilocybin analogue, showing nearly a 16-point placebo-adjusted reduction on the same scale at day eight. While direct comparisons are fraught due to protocol and timing differences, the contrast points towards a key challenge for Compass: demonstrating that COMP360 offers both efficacy and convenience superior to current alternatives. GH’s trial employed a titrated dose and evaluated outcomes at an earlier timepoint, which may have limited placebo response and enhanced effect size. These nuances matter, particularly in psychiatric trials where expectation effects are notoriously difficult to control. From a safety perspective, Compass reported no new signals, with its independent data monitoring committee confirming a consistent safety profile and no clinically meaningful imbalance in suicidality between treatment arms, a critical consideration in TRD populations. Still, commercial viability remains an open question. Johnson & Johnson’s Spravato ( esketamine ), an intranasal therapy for TRD approved in 2019, generated over $1 billion in sales last year, largely driven by a broader label and entrenched payer relationships. Compass, by contrast, is navigating an uncharted reimbursement landscape for psychedelic-assisted therapy, with questions remaining around scalability, infrastructure requirements, and healthcare provider training. Evercore ISI analyst Gavin Clark-Gartner downgraded the stock following the announcement, characterizing the outcome as insufficiently convincing. " With clinical and commercial question marks, the second [Phase 3 study] will remain a ‘show me’ story for investors in an increasingly competitive landscape,” he wrote. Those results, evaluating longer-term outcomes over a 26-week horizon, are expected in the second half of next year. Until then, Compass must contend not only with a skeptical market but with a rapidly evolving field that continues to challenge traditional notions of drug development in mental health. Author BioFocus Newsroom Previous Next