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A groundbreaking clinical trial set to begin in summer 2026 will test LungVax, the world’s first vaccine designed to prevent lung cancer in people at high risk, a major milestone in cancer prevention research. < Back World-First Preventative Lung Cancer Vaccine Enters Clinical Trial A groundbreaking clinical trial set to begin in summer 2026 will test LungVax, the world’s first vaccine designed to prevent lung cancer in people at high risk, a major milestone in cancer prevention research. Developed by researchers at the University of Oxford and University College London, and backed by Cancer Research UK and the CRIS Cancer Foundation, LungVax aims to prime the immune system to detect and destroy abnormal lung cells before they turn cancerous. “Lung cancer is lethal and blights far too many lives. Survival has been stubbornly poor for decades. LungVax is our chance to do something to actively prevent this disease,” said Professor Sarah Blagden, co-founder of the LungVax project. How LungVax Works LungVax uses a viral vector technology based on the same platform that powered the Oxford/AstraZeneca COVID-19 vaccine. It delivers genetic instructions to the immune system so it can recognise “red-flag” proteins (neoantigens) on the surface of early abnormal lung cells, marking them for the immune system to destroy. The Phase I trial will focus on individuals at particularly high risk, including patients who have had early-stage non-small cell lung cancer removed, as well as people currently enrolled in NHS England’s targeted lung health checks. Trial Design and Scope The Oncology Clinical Trials Office (OCTO) at Oxford will run the trial. It is designed as a dose-escalation Phase I, followed by a Phase II “precision-prevention” part. The total planned enrollment is 590 patients: 30 in Phase I and 560 in Phase II (280 per arm). The primary goals are to assess safety, determine optimal dosing, and evaluate whether the immune response can be effectively triggered. “Fewer than 10% of people with lung cancer survive their disease for 10 years or more. That must change, and that change will come from targeting lung cancer at the earliest stages,” said Professor Mariam Jamal-Hanjani, trial lead from UCL. Why This Matters Lung cancer remains the UK’s deadliest cancer by survival rate, and early detection continues to be a major challenge. By training the immune system to identify and eliminate abnormal lung cells early, before full-blown cancer develops, LungVax represents a paradigm shift in primary prevention. The vaccine does not replace existing public health measures: smoking cessation remains the most effective way to reduce lung cancer risk. But LungVax could offer a completely new layer of protection for those most vulnerable, especially as part of broader screening programmes. Backing and Future Prospects Cancer Research UK has awarded up to £2.06 million to support the four-year Phase I trial. Michelle Mitchell, Chief Executive of Cancer Research UK, emphasised the long-term vision: “By supporting the LungVax clinical trial, we will put the vaccine through the most rigorous scientific tests and take that important first step towards a world where people live longer, better lives, free from the fear of lung cancer.” The program also builds on a larger GSK-Oxford immuno-prevention partnership, which launched in early 2025, with a £50 million investment in pre-cancer vaccine research. LungVax could redefine how we approach lung cancer prevention, shifting the paradigm from reacting to disease to preventing it altogether. If the trial proves successful, this could become a powerful tool for reducing lung cancer incidence in high-risk populations. Author BioFocus Newsroom Previous Next

Can CagriSema increase the efficacy of obesity treatment and preserve Novo Nordisk's leading position in the market? < Back Novo Nordisk’s CagriSema and the Competitive Dynamics in the Obesity Drug Market Can CagriSema increase the efficacy of obesity treatment and preserve Novo Nordisk's leading position in the market? [Nov 9th, 2024] - Obesity Week 2024 took place last week in San Antonio and, perhaps not unsurprisingly, one of the main topics of discussion was semaglutide, the active ingredient in Wegovy, Novo Nordisk’s flagship obesity drug. Of particular interest was the SELECT study, a randomized, controlled trial which assessed cardiovascular outcomes in patients taking semaglutide vs placebo. For Novo (and of course for obesity patients), new indications for Wegovy that highlight semaglutide’s broader health benefits are great news, but, for the Danish pharmaceutical giant, is this enough amidst an increasingly competitive landscape where rivals such as Eli Lilly are threatening to outperform Wegovy’s weight loss capability? Novo Nordisk’s semaglutide-based drugs, marketed under the brand names Ozempic and Wegovy, have fundamentally transformed the landscape for obesity and diabetes treatment, bringing weight loss capabilities that rival surgical interventions to patients within a simple self-administered dosing pen. Semaglutide, a GLP-1 agonist, has gained substantial market traction and is poised to become the top-selling pharmaceutical product globally in 2024, in the process making Novo Nordisk Europe’s biggest company by market cap. But the competitive environment in the obesity therapeutics market is intensifying rapidly. Novo faces increasing challenges from Eli Lilly’s GLP-1/GIP dual agonist, Zepbound (Mounjaro), and emerging generics as patents near expiration in major markets like the U.S., Europe, and China. In response, Novo is leveraging a new combination therapy, CagriSema, which integrates semaglutide with an amylin analog, cagrilintide. CagriSema could represent the next frontier in multi-receptor obesity treatment, potentially providing superior weight-loss outcomes while maintaining manageable side effects. Here we explore the competitive landscape, the scientific rationale behind CagriSema, its market potential, and the substantial challenges that lie ahead for Novo in the obesity therapeutics space. Competitive Landscape: The GLP-1 Agonist Market and New Entrants The global obesity market is projected to reach $130 billion by 2030, driven by the success of GLP-1 agonists such as Wegovy and the increasing prevalence of obesity and related metabolic diseases. Despite Wegovy’s significant impact, Eli Lilly’s Zepbound has entered the market with compelling efficacy data , showing up to 21% weight reduction in clinical trials compared to Wegovy’s 15% weight reduction. Eli Lilly’s head-to-head trial between Zepbound and Wegovy, expected by year-end, may further highlight the advantages of its dual-action mechanism, positioning it as a formidable competitor. Additionally, Eli Lilly’s triple-agonist compound, retatrutide, targets GLP-1, GIP, and glucagon receptors and has demonstrated up to 24% weight loss in clinical trials, setting a new benchmark in obesity therapy. In this context, Novo’s success with CagriSema hinges on its ability to deliver superior or at least comparable outcomes. CagriSema’s 25% weight-loss target would position it competitively above existing treatments and could help Novo retain market leadership. However, should CagriSema fall short or produce substantial side effects, Novo risks losing its competitive edge to Zepbound and potentially other emerging options, including oral therapies from both Novo and Eli Lilly. The Scientific Foundation of CagriSema: Combining GLP-1 and Amylin CagriSema combines GLP-1 and amylin agonists to harness the complementary mechanisms of these hormones in promoting satiety and weight loss. GLP-1 agonists work by slowing gastric emptying and enhancing insulin secretion, thereby reducing food intake and aiding glycemic control. Amylin, on the other hand, modulates satiety through a distinct neural pathway. The rationale is that amylin’s unique mechanism may reduce the “yo-yo” weight-regain effect commonly seen with obesity drugs, potentially resulting in more sustained weight loss. The inclusion of cagrilintide, an amylin analog, is a strategic decision that could address some limitations of GLP-1 monotherapy. Amylin has shown the potential to extend satiety effects without the gastrointestinal side effects typically associated with GLP-1 therapies, such as nausea and vomiting. The dual action of GLP-1 and amylin in CagriSema could thus offer enhanced weight loss with a more tolerable side-effect profile. This novel approach has attracted considerable interest from competitors, with companies like Zealand Pharma and Eli Lilly developing their own amylin-based candidates. The question that remains, however, is whether CagriSema can deliver on its promise. While preclinical and initial clinical data appear promising, the December readout from CagriSema’s large-scale clinical trial will be crucial. Positive results could solidify amylin’s role as a target in anti-obesity pharmacotherapy and position CagriSema as a leading therapy in the space. However, any failure to meet its weight-loss targets or adverse side-effect revelations could significantly impact Novo’s market position. Addressing the Manufacturing Complexity and Supply Constraints Novo Nordisk has struggled to keep up with global demand for Wegovy and Ozempic, largely due to the supply challenges inherent in biologic production. For CagriSema, the manufacturing demands will be even greater. Unlike single-agent therapies, CagriSema’s formulation requires a dual-chamber syringe to keep the GLP-1 and amylin analogs separate until the point of administration. This dual-chamber technology is complex and has not been commercialized at scale, which may limit Novo’s ability to rapidly meet potential demand. While Novo has invested in expanding its manufacturing facilities to address these issues, the complexity of CagriSema production may slow its rollout and leave Novo vulnerable to supply disruptions, especially as rivals with simpler formulations enter the market. The potential future development of an integrated single-syringe version of CagriSema could alleviate some of these production hurdles. However, this pathway presents additional technical and regulatory challenges and may not be viable in the near term. Shifting Market Dynamics and Emerging Oral Therapeutics While the current market is dominated by injectable biologics, the future of obesity treatment could shift toward oral therapies. Oral delivery options could improve patient adherence and accessibility, particularly for individuals who may be averse to injections. Novo Nordisk and Eli Lilly have both explored oral formulations of GLP-1 and other analogs. However, Novo faces setbacks in this area, as one of its early-stage oral candidates did not meet analysts’ expectations. Eli Lilly’s oral compounds, on the other hand, are showing promise and could soon become a competitive threat. If CagriSema proves successful, Novo could have a temporary advantage, but the long-term market focus may shift toward more convenient oral formulations. For Novo to maintain its market position, it must ensure that its research pipeline includes viable oral candidates and that it can navigate the challenges of manufacturing potent, stable oral biologics—a challenging feat but one that could ultimately secure Novo’s market presence against injectable and generic competitors alike. Strategic Imperatives for Novo Nordisk Novo Nordisk’s journey from a GLP-1 pioneer to a potential leader in multi-receptor obesity therapeutics reflects the company’s innovative and adaptable approach. CagriSema embodies Novo’s next step in advancing obesity pharmacotherapy, combining GLP-1 and amylin’s synergistic effects to potentially deliver superior weight loss outcomes with fewer side effects. Nevertheless, this ambitious project faces formidable challenges, from clinical validation and patent protection to complex manufacturing and competitive pressures. The global obesity drug market is intensifying, with competitors like Eli Lilly pushing the boundaries of multi-receptor agonist therapy, both in injectables and oral formulations. In this high-stakes environment, Novo must execute a twofold strategy: first, deliver CagriSema successfully to market while maintaining its efficacy and safety profile; second, continue to invest in next-generation therapies, particularly in oral formulations, to capture evolving patient preferences. Ultimately, Novo’s future in the obesity market depends on its ability to overcome the immediate challenges and prepare for the shifting competitive dynamics ahead. If Novo succeeds in its ambitious goals for CagriSema and capitalizes on its R&D investments in emerging therapies, it stands a strong chance of preserving its leadership in the multi-billion-dollar obesity drug market. Author BioFocus Newsroom Previous Next

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< Back GE HealthCare & MediView Launch AR Headset for Image-Guided Procedures GE HealthCare and MediView have now for the first time implemented the OmnifyXR, an augmented reality (AR) headset designed to facilitate image-guided medical procedures. After first announcing their collaboration back in November 2022, GE HealthCare and MediView have now for the first time implemented the OmnifyXR, an augmented reality (AR) headset designed to facilitate image-guided medical procedures. This innovative system equips surgeons with a wearable heads-up display, capable of showing up to four information feeds, including X-ray fluoroscopy, ultrasound imaging, and blood flow data, in real-time. By projecting 3D anatomical holograms directly into the surgeon's field of vision, the headset enables more precise and focused operations. Key Features and Benefits: 3D Anatomical Holograms: The headset provides detailed 3D visualizations of patient anatomy, enhancing spatial awareness and precision during procedures. Multi-Feed Display: Integrates various imaging modalities like X-ray, ultrasound, and blood flow data into a single view. Enhanced Focus and Sterility: Surgeons can interact with holographic models without diverting their gaze or compromising sterility, as hand gestures can manipulate the 3D images. Remote Collaboration: The system supports remote viewing and collaboration, allowing clinicians to consult in real-time from different locations. Initial Deployment: The OmnifyXR has been successfully deployed at North Star Vascular and Interventional in Minneapolis. In its initial use, the headset has aided in procedures to address problematic arteries, demonstrating its potential to improve surgical outcomes and operational efficiency. Future Prospects: The introduction of the OmnifyXR marks a significant step forward in medical technology, potentially setting a new standard for image-guided procedures. Its ability to merge advanced imaging with AR technology could lead to widespread adoption in various surgical fields, enhancing the precision and safety of medical interventions. This collaboration between GE HealthCare and MediView represents a significant advancement in the integration of AR technology within the medical field, promising improved patient outcomes and streamlined surgical procedures. Author BioFocus Newsroom Previous Next

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Strategic move boosts the Swiss pharmaceutical company's shares. < Back Roche Accelerates Anti-Obesity Drug Development to Rival Eli Lilly and Novo Nordisk Strategic move boosts the Swiss pharmaceutical company's shares. Roche , a leading Swiss pharmaceutical company, is expediting the development of its anti-obesity drugs to compete with industry giants Eli Lilly and Novo Nordisk in the rapidly expanding market. This move follows the unveiling of promising data for a new weight-loss pill. Thomas Schinecker, Roche’s CEO, disclosed to the Financial Times that the company’s first anti-obesity treatments are expected to reach the market "significantly faster than people are expecting," potentially by 2028. These treatments, part of an up to $3.1 billion acquisition of biotech firm Carmot Therapeutics last year, include a weight-loss injection entering phase II trials and a pill that demonstrated a 6.1% weight reduction compared to a placebo after four weeks. The Carmot acquisition could yield approximately seven drugs, with several in early development stages, though Roche has disclosed details for only three assets so far. Recent data from the weight-loss pill boosted Roche's shares by 6% on the day of the announcement, while shares of Novo Nordisk and Eli Lilly declined amid concerns about potential competition from Roche. Goldman Sachs analysts project that the obesity market will exceed $130 billion by 2030, with multiple companies vying to introduce their treatments. Roche faces the challenge of catching up with established players like Novo Nordisk and Eli Lilly, whose drugs Wegovy and Mounjaro have achieved approximately 15% and 20% weight loss, respectively, in trials lasting over a year. Other pharmaceutical companies, including Boehringer Ingelheim and Pfizer, are also aiming to enter the obesity drug market. Shares of US biotech Viking Therapeutics surged by 30% after announcing plans to advance an obesity pill to late-stage trials. Schinecker highlighted the scalability of Roche’s weight-loss pill, which is synthetically manufactured rather than derived from natural peptides, as is the case with Novo Nordisk’s pill. This synthetic approach could potentially streamline production and distribution processes. Barclays analyst Emily Field remarked that while Roche’s early data is promising, it remains uncertain whether the company can disrupt the head start held by Novo Nordisk and Eli Lilly. "If you look at what’s disclosed, it’s better than pretty much everything at four weeks. But there’s a lot we don’t know," she noted, referring to the lack of detailed information on potential side effects like nausea and vomiting. Since taking over as CEO in March 2023, Schinecker has overseen a significant restructuring at Roche, including cutting 25% of underperforming drugs in development. The company is now focusing on a more selective but promising portfolio of drugs, including those targeting obesity and Alzheimer’s disease. "That creates room for new starts and things that we can bring in from the outside so that you don’t carry projects for too long and then you find resources that you could put to much more effective use to develop new medicines," Schinecker explained. Roche’s strategic shift follows a series of research setbacks, such as the recent failure of a late-stage trial for its lung cancer drug tiragolumab to show superior survival rates compared to Merck's Keytruda. Schinecker expressed optimism that Roche’s obesity drugs might also be used in combination with the company’s other treatments for obesity-related conditions. He highlighted the success of Vabysmo, a blockbuster eye treatment developed with subsidiary Genentech, which generated CHF 1.8 billion ($2.1 billion) in sales in the first half of the year and shows promise in treating diabetic macular edema. Buoyed by strong sales of Vabysmo and the multiple sclerosis drug Ocrevus, Roche raised its expected earnings per share growth for 2024 to the high single-digit range, up from previous guidance of a mid-single-digit increase. Author BioFocus Newsroom Previous Next

In a landmark advancement for genetic medicine, the NHS is set to offer a revolutionary gene therapy, Casgevy, to patients with transfusion-dependent beta thalassaemia. < Back NHS Introduces Groundbreaking Gene Therapy for Beta Thalassaemia In a landmark advancement for genetic medicine, the NHS is set to offer a revolutionary gene therapy, Casgevy, to patients with transfusion-dependent beta thalassaemia. The new therapy, developed by Vertex Pharmaceuticals and CRISPR Therapeutics , marks a significant milestone in the treatment of this severe genetic blood disorder. Casgevy has been approved by the National Institute for Health and Care Excellence (NICE) and will be available from August 7. It is anticipated to benefit around 460 patients in England. Beta thalassaemia, a condition where the body produces insufficient haemoglobin, affects approximately 2,300 people in the UK, predominantly those of Mediterranean, Asian, or Middle Eastern descent. The disorder often leads to severe anaemia, necessitating lifelong blood transfusions and reducing life expectancy to around 50 years. Casgevy offers a potential cure by employing CRISPR gene-editing technology. The treatment involves extracting stem cells from a patient's bone marrow, modifying the genes in a lab to produce functioning haemoglobin, and reinfusing the corrected cells back into the patient. This process reprograms the cells to produce foetal haemoglobin, bypassing the genetic defect that hampers adult haemoglobin production. In clinical trials, 93% of patients did not require blood transfusions for at least a year post-treatment. "This is a historic moment for people living with beta thalassaemia," said Amanda Pritchard, NHS Chief Executive. "This therapy offers a life free from regular transfusions and the debilitating symptoms of the disorder, promising a longer and healthier life." The gene-editing tool CRISPR, which won the Nobel Prize for Chemistry in 2020, is integral to this treatment. It precisely targets and edits the DNA responsible for the haemoglobin switch from foetal to adult forms. This innovative approach not only addresses the symptoms but also targets the root cause of beta thalassaemia. The therapy's introduction follows a thorough evaluation by NICE, which considered both its costs and benefits. While the listed price of Casgevy is £1.65 million per patient, NHS England has negotiated a lower price to make it accessible. The treatment will be available at seven specialist centres across the UK, ensuring it reaches those in need efficiently. "This transformative treatment offers patients a life-changing opportunity, enabling them to repair their own cells and embrace a future free from the challenges of their condition," stated Romaine Maharaj, Executive Director of the UK Thalassaemia Society. This gene therapy not only represents a breakthrough for beta thalassaemia but also paves the way for future treatments of other genetic disorders, such as sickle cell anaemia, which is currently under negotiation for NHS approval. The rollout of Casgevy by the NHS signifies a new era in the treatment of genetic blood disorders, providing hope and improved quality of life for many patients. This advancement underscores the potential of gene therapy to address and potentially cure debilitating conditions, marking a significant achievement in medical science. Author BioFocus Newsroom Previous Next

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< Back Training the Immune System to Outlast Cancer Personalized RNA vaccines show long-term promise in pancreatic cancer, new study reports. Pancreatic cancer, particularly pancreatic ductal adenocarcinoma (PDAC), is one of the deadliest forms of cancer, with limited treatment options and a high rate of recurrence after surgery. However, a new study published in Nature reports that personalized RNA vaccines can train the immune system to fight back, potentially delaying or even preventing the return of the disease. One of the biggest hurdles in cancer treatment is getting the immune system to recognize and attack cancer cells. Cancer vaccines aim to do just that by targeting specific proteins, or "neoantigens," that are unique to the tumor. But in pancreatic cancer, which has relatively few mutations, this has been particularly challenging. The new study, led by researchers at Memorial Sloan Kettering Cancer Center, tackles this problem head-on with a novel approach: personalized RNA vaccines designed to prime the immune system to recognize and destroy cancer cells. A Personalized Approach The researchers conducted a phase I clinical trial involving 19 patients who had undergone surgery to remove their pancreatic tumors. After surgery, patients received a combination of treatments: a single dose of atezolizumab (an immune checkpoint inhibitor), followed by a personalized RNA vaccine called autogene cevumeran , and then a standard chemotherapy regimen known as mFOLFIRINOX. The vaccine was tailor-made for each patient, targeting up to 20 unique neoantigens—mutated proteins found only in their tumors. The goal was to train the immune system, specifically CD8+ T cells, to recognize and attack any remaining cancer cells, reducing the risk of recurrence. The results were striking. At a median follow-up of 3.2 years, patients who responded to the vaccine—meaning their immune systems produced a strong T cell response—had significantly longer recurrence-free survival compared to non-responders. In fact, the median recurrence-free survival for responders had not yet been reached, while non-responders had a median survival of just 13.4 months. Even more impressive was the longevity of the immune response. The vaccine-induced T cells were estimated to persist for an average of 7.7 years, with some clones potentially lasting for decades. These T cells not only stuck around but also remained functional, retaining their ability to recognise and attack cancer cells. This is a critical finding, as long-lasting immunity is essential for preventing cancer from coming back. How does it work? The vaccine works by introducing RNA sequences that encode the neoantigens into the body. These RNA sequences are packaged in lipid nanoparticles, which help deliver them to immune cells. Once inside, the immune cells use the RNA to produce the neoantigens, effectively training the immune system to recognize and attack cancer cells that display these same proteins. The study also revealed that the vaccine-induced T cells were mostly "de novo," meaning they were newly generated in response to the vaccine rather than pre-existing in the body. This is important because it suggests that the vaccine can kickstart an immune response even in patients whose immune systems haven’t naturally recognized the cancer. Using advanced single-cell RNA and TCR sequencing, the researchers tracked the behavior of these T cells over time. They found that the T cells went through several phases: first proliferating rapidly, then contracting, and finally settling into a long-lasting memory state. Importantly, these memory T cells retained their ability to kill cancer cells, even years after vaccination. In patients who experienced a recurrence, the tumors showed signs of "clonal pruning," meaning that the cancer cells targeted by the vaccine were largely eliminated. This suggests that the vaccine-induced T cells were actively working to keep the cancer in check. What does this mean for patients? For patients with pancreatic cancer, these findings are a beacon of hope. The study shows that it’s possible to generate a strong, long-lasting immune response against a cancer that has historically been very difficult to treat. While the results are still early and need to be confirmed in larger trials, the potential is enormous. The personalized nature of the vaccine is particularly exciting. By targeting the unique mutations in each patient’s tumor, the vaccine can potentially be adapted to treat a wide range of cancers, not just pancreatic cancer. This approach could be especially beneficial for cancers with low mutation rates, where traditional immunotherapy has struggled to make an impact. The researchers are already planning the next steps. A global randomized trial, called IMCODE 003, is underway to further test the efficacy of the vaccine in a larger group of patients. If successful, this could pave the way for a new era of personalized cancer vaccines, offering hope to patients with some of the most challenging forms of the disease. This study represents a significant leap forward in the fight against pancreatic cancer. By harnessing the power of personalized RNA vaccines, researchers have shown that it’s possible to train the immune system to recognize and attack cancer cells, potentially preventing recurrence and improving survival. While there’s still much work to be done, the results are a promising step toward a future where cancer vaccines could become a standard part of treatment, offering new hope to patients worldwide. Author BioFocus Newsroom Previous Next

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

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