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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" xmlns:media="http://search.yahoo.com/mrss/" > <channel> <title>International Biopharmaceutical Industry</title> <atom:link href="https://international-biopharma.com/feed/" rel="self" type="application/rss+xml" /> <link>https://international-biopharma.com</link> <description>Supporting Modern Science Through Communication</description> <lastBuildDate>Thu, 30 Oct 2025 14:45:38 +0000</lastBuildDate> <language>en-GB</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.8.3</generator> <image> <url>https://international-biopharma.com/wp-content/uploads/2021/03/IBI-150x150.jpg</url> <title>International Biopharmaceutical Industry</title> <link>https://international-biopharma.com</link> <width>32</width> <height>32</height></image> <item> <title>VALANX Biotech appoints Klaus Orlinger, PhD. as Chief Scientific Officer</title> <link>https://international-biopharma.com/valanx-biotech-appoints-klaus-orlinger-phd-as-chief-scientific-officer/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 30 Oct 2025 14:45:37 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18214</guid> <description><![CDATA[VALANX Biotech (VALANX), a biotech company developing novel technology for site-specific protein conjugation in drug discovery, today announced the appointment of Klaus Orlinger, PhD. as Chief Scientific Officer. With more than 15 years of industry experience in the development of oncology and infectious disease drug candidates, Klaus will drive the Company’s scientific strategy including development […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>Strategic hire of industry expert bolsters leadership team as Company progresses first antibody drug conjugate to candidate selection phase</em></li> <li><em>Appointment will drive development of VALANX’ GoldenSite<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> platform to advance development of best-in-class therapeutic protein conjugates</em></li></ul> <p></p> <p>VALANX Biotech (VALANX), a biotech company developing novel technology for site-specific protein conjugation in drug discovery, today announced the appointment of Klaus Orlinger, PhD. as Chief Scientific Officer. With more than 15 years of industry experience in the development of oncology and infectious disease drug candidates, Klaus will drive the Company’s scientific strategy including development of its flagship protein conjugation platform.</p> <p>In his role, Klaus will lead VALANX’ strategic drug development roadmap, ensuring long-term growth and success for the Company. Integral to this, will be the development of VALANX’ GoldenSite conjugation platform and the translation of the platform’s capabilities for the discovery of promising, novel therapeutic protein conjugates. The Company’s technology leverages synthetic biology and click chemistry to enable rapid and reliable site-specific and freely site-selective protein conjugation, combining them with other molecular units to create novel biotherapeutics with superior therapeutic windows.</p> <p>Klaus is an experienced R&D leader with a distinguished track record in pharmaceutical product development joining VALANX from HOOKIPA Pharma, where he has been instrumental in driving innovation and growth. Over his tenure, he played a central role in advancing multiple drug candidates in immuno-oncology and infectious disease from early research through phase 1 and 2 clinical studies in the US and EU.</p> <p>Serving as Chief Scientific Officer, Vice President Research, and Head of Virology, Klaus contributed significantly to HOOKIPA’s strategic development, the establishment of key research and pharma partnerships, and the company’s communications with investors. His leadership was pivotal in transforming HOOKIPA from an early-stage concept into a clinical-stage biotech company, successfully guiding it from seed funding to IPO. Klaus holds a degree, Masters and PhD in Genetics and Microbiology from the University of Vienna.</p> <p><em>“Klaus’ world-class expertise in executing on drug development programs represents a decisive milestone for the company. His knowledge and experience will be instrumental in guiding us as our first antibody-drug-conjugate, VLX-ADC-001, enters candidate selection,” </em><strong>said Michael Lukesch, Founder and Chief Executive Officer at VALANX Biotech.</strong> <em>“Welcoming Klaus, a world-class expert in pharmaceutical drug development, to strengthen our leadership team is a reflection of the potential of our technology for the development of novel therapies that will make a key difference for patients.”</em></p> <p><strong>Klaus Orlinger, PhD., Chief Scientific Officer at VALANX Biotech, commented: </strong><em>“Drug-protein-conjugate therapeutics hold great potential for a broad range of diseases but their clinical development is often hampered by limited therapeutic windows. VALANX’s GoldenSite technology is addressing an urgent need to widen limited therapeutic windows and enable the development of best-in-class biotherapeutic drugs. I am excited to have joined the team at a pivotal moment for the company to drive the execution of its drug development programs and to generate more candidate drugs to address unmet medical need in oncology.”</em></p>]]></content:encoded> </item> <item> <title>ProImmune Ltd introduces ProVE® SL Self-Loading MHC Class I Monomers to improve T cell research flexibility</title> <link>https://international-biopharma.com/proimmune-ltd-introduces-prove-sl-self-loading-mhc-class-i-monomers-to-improve-t-cell-research-flexibility/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 30 Oct 2025 14:32:30 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18210</guid> <description><![CDATA[ ProImmune Ltd, a global leader in life science reagents and services, today announced the launch of its new ProVE® SL Self-Loading MHC Class I Monomers. The novel reagents for antigen-specific CD8+ T cell detection are designed to offer researchers unprecedented flexibility, speed, and MHC allele-coverage, with over 50 HLA alleles available. Supplied as highly robust, empty, biotinylated […]]]></description> <content:encoded><![CDATA[<p></p> <p> ProImmune Ltd, a global leader in life science reagents and services, today announced the launch of its new ProVE<sup>®</sup> <em>SL</em> Self-Loading MHC Class I Monomers. The novel reagents for antigen-specific CD8+ T cell detection are designed to offer researchers unprecedented flexibility, speed, and MHC allele-coverage, with over 50 HLA alleles available.</p> <p>Supplied as highly robust, empty, biotinylated MHC Class I molecules, ProImmune’s ProVE <em>SL </em>Monomers offer an extended allele range including HLA-A, HLA-B, HLA-C and non-canonical alleles, as well as mouse H-2. The ProVE <em>SL</em> platform allows researchers to load their own peptides and flexibly combine monomers with a wide range of avidin or streptavidin conjugates—including fluorescent, barcoded, or mass-cytometry reagents—to easily create tetramers or surface-bound complexes. This flexibility enables faster experimental setup, reconfiguration of panels, expanded donor-cohort coverage, including less common alleles, and integration with advanced flow and mass cytometry or single-cell RNA sequencing workflows.</p> <p>T cell immunology, epitope mapping and immune-monitoring workflows increasingly demand reagents that permit rapid customisation across diverse HLA contexts. The ProVE <em>SL</em> monomers address key limitations of conventional pre-loaded MHC monomers, which often restrict peptide choice, require complex loading and exchange steps, or cover only frequent alleles. By enabling self-loading of peptides, the ProVE <em>SL</em> platform empowers immunologists to adapt their reagents more quickly to new antigens, for example for infectious diseases, cancer neo-antigens, autoantigens, and measuring vaccine responses and to study donor cohorts with rarer HLA types.</p> <p><em>“With the launch of our new ProVE SL monomers, we are offering researchers the ability to customise MHC monomer reagents at unprecedented speed and breadth,”</em> <strong>said Dr. Nikolai Schwabe, CEO at ProImmune.</strong> <em>“This flexibility will accelerate epitope mapping, immune-monitoring and translational across research programmes, including in infectious disease and oncology. ProVE SL Monomers are a natural extension to our market-leading product ranges in MHC Class I/II monomers, multimers, and immunology services, as well as our extensive peptide synthesis capability”.</em></p> <p>The ProVE <em>SL</em> Self-Loading MHC Class I Monomers are available now through ProImmune’s catalog and distributor network. For more information, visit: <a href="https://www.proimmune.com/prove-sl-self-loading-mhc-class-i-monomers" target="_blank" rel="noreferrer noopener">https://www.proimmune.com/prove-sl-self-loading-mhc-class-i-monomers</a></p> <p>To order online, visit: <a href="https://www.proimmune.com/product-category/mhc-multimers/self-loading-mhc-class-i-monomers" target="_blank" rel="noreferrer noopener">https://www.proimmune.com/product-category/mhc-multimers/self-loading-mhc-class-i-monomers</a></p>]]></content:encoded> </item> <item> <title>Qureight Vascul8 model for pulmonary vascular disorders validated in peer-reviewed study, offering potential to improve treatment options and patient outcomes following surgery</title> <link>https://international-biopharma.com/qureight-vascul8-model-for-pulmonary-vascular-disorders-validated-in-peer-reviewed-study-offering-potential-to-improve-treatment-options-and-patient-outcomes-following-surgery/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Mon, 27 Oct 2025 10:24:14 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18207</guid> <description><![CDATA[Qureight, a techbio company advancing the understanding of lung and heart disease through application of its AI-powered imaging and clinical data curation platform, today announced the publication of a peer-reviewed study validating its Vascul8™ model for pulmonary vascular disorders, in the American Journal of Respiratory Cell and Molecular Biology1. The study demonstrated that the Vascul8 model provides accurate, […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>Study published in ‘American Journal of Respiratory Cell and Molecular Biology’ validates Qureight’s deep-learning models and imaging platform beyond fibrotic lung disease, into new therapeutic areas for severe respiratory disease</em></li> <li><em>Data demonstrate sensitive quantification of vascular remodelling and prediction of disease severity from routine CT scans, following surgical removal of chronic blood clots</em></li> <li><em>Automated insights from application of Vascul8 model enabled identification of patients at high risk of residual pulmonary hypertension post-surgery which will reduce the need for routine post-operative right heart catheterisation</em></li></ul> <p></p> <p>Qureight, a techbio company advancing the understanding of lung and heart disease through application of its <a>AI-powered imaging and clinical data curation platform</a>, today announced the publication of a peer-reviewed study validating its Vascul8<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> model for pulmonary vascular disorders, in the <em>American Journal of Respiratory Cell and Molecular Biology</em><sup>1</sup>. The study demonstrated that the Vascul8 model provides accurate, automated insights into response to surgery for patients treated for chronic thromboembolic pulmonary hypertension (CTEPH). These insights enabled the identification of patients at high-risk of residual pulmonary hypertension, reducing the need for routine post-operative right heart catheterisation.</p> <p>CTEPH is caused by the presence of chronic blood clots (chronic pulmonary thromboembolisms) in the arteries of the lung that do not fully break down. Pulmonary endarterectomy (PEA) surgery is often carried out to remove the clots; however, patients can be left with residual pulmonary hypertension (PH) and require further intervention or treatment. The current approach to stratify patients at risk of pulmonary hypertension involves right heart catheterisation (RHC), an invasive and resource intensive procedure, to measure pressure and blood flow in pulmonary circulation. The findings reported in this paper show we can effectively screen patients for residual PH, and therefore perform right heart catheterisation only on those with high risk for residual PH, reducing the number of invasive, costly procedures.</p> <p>Qureight’s AI-powered imaging and clinical data curation platform and deep learning models identify key structural changes in the lung to assess disease progression. In this study, Qureight’s Vascul8 model was used to analyse Computed Tomography Pulmonary Angiograms (CTPAs) to quantify changes in blood vessel volume in patients with CTEPH following PEA surgery. Analysis with Vascul8 enabled precise vascular segmentation, including differentiating between arterial and venous blood volume, providing an objective, automated approach to identifying changes in vessel volume and predicting which patients are most at risk of residual pulmonary hypertension. This study demonstrates how Qureight’s deep learning technology offers a more personalised, accurate and non-invasive approach to CTEPH treatment management, providing physicians with deeper insights into a patient’s severity of disease and need for further intervention.</p> <p><strong>Joanna Pepke-Zaba, Consultant Physician, Royal Papworth Hospital NHS Foundation Trust, Associate Professor, University of Cambridge, and lead author of the paper, said: </strong><em>“CTEPH has for a long time had a complex disease management pathway, requiring the subjective expertise of multidisciplinary teams. We are excited to have worked on this study where we show an alternative approach to imaging CTEPH and patient management, employing Qureight’s imaging analysis model, Vascul8. This signals a major step forward in deploying imaging in severe and complex respiratory and vascular diseases.”</em></p> <p><strong>Hakim Ghani, Research Fellow, Royal Papworth Hospital NHS Foundation Trust and first author of the paper, added:</strong> <em>“Powered by Vascul8, automated quantification of lung blood volumes from CT scans can help identify patients with chronic blood clots who remain at risk of residual pulmonary hypertension after surgery. This AI-driven imaging approach could guide better treatment decisions, support more personalised care, reduce the need for invasive tests, and enable new endpoints in clinical trials – overall offering huge potential for patient benefit.”</em></p> <p><strong>Simon Walsh, CSO,</strong><strong> </strong><strong>Qureight, and co-author of the paper, commented: </strong><em>“This study shows the promise of our deep-learning vascular biomarkers and demonstrates that our imaging platform can be used beyond fibrotic lung disease, in pulmonary vascular disorders such as CTEPH. This breakthrough establishes the foundation for future biopharma partnerships in pulmonary vascular disease, reinforcing our leadership position in regulatory-grade, disease-agnostic imaging biomarkers built for clinical and translational research, to accelerate drug development, enable smarter patient selection, and support precision medicine.”</em><em></em></p> <ol class="wp-block-list"><li>Ghani, H. <em>et al. </em>(2025) “Pulmonary Blood Volumes on CT Predict Residual Pulmonary Hypertension Post-Pulmonary Endarterectomy,” <em>American Journal of Respiratory Cell and Molecular Biology, </em><a href="https://www.atsjournals.org/doi/abs/10.1165/rcmb.2025-0121OC?journalCode=ajrcmb" target="_blank" rel="noreferrer noopener">doi:10.1165/rcmb.2025-0121OC</a></li></ol>]]></content:encoded> </item> <item> <title>IMCD showcases greener, smarter, patient-centric solutions at CPHI Frankfurt 2025</title> <link>https://international-biopharma.com/imcd-showcases-greener-smarter-patient-centric-solutions-at-cphi-frankfurt-2025/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Fri, 24 Oct 2025 09:21:34 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18205</guid> <description><![CDATA[IMCD Group (“IMCD” or “Company”), a global leading partner for the distribution and formulation of speciality chemicals and ingredients, will exhibit at CPHI Frankfurt 2025 from 28 to 30 October, where its experts will unveil a portfolio of greener, smarter, patient-centric solutions designed to meet the evolving demands of the pharmaceutical industry. At this year’s event, IMCD will highlight how […]]]></description> <content:encoded><![CDATA[<p>IMCD Group (“IMCD” or “Company”), a global leading partner for the distribution and formulation of speciality chemicals and ingredients, will exhibit at CPHI Frankfurt 2025 from 28 to 30 October, where its experts will unveil a portfolio of greener, smarter, patient-centric solutions designed to meet the evolving demands of the pharmaceutical industry.</p> <p>At this year’s event, IMCD will highlight how its technical expertise, sustainable innovation, and collaborative approach are helping customers accelerate development and deliver better outcomes for patients.</p> <p>Showcasing a curated selection of formulations, these concepts deliver tangible solutions to the pressing challenges in pharmaceutical development today. Concepts at the booth will sit under three key themes:</p> <ul class="wp-block-list"><li><strong>Greener</strong>: Solutions that deliver sustainability across the pharmaceutical value chain. From sourcing eco-friendly excipients to promoting energy-efficient manufacturing processes. These concepts reduce environmental impact without compromising performance.</li></ul> <ul class="wp-block-list"><li><strong>Smarter</strong>: Leveraging its global network of technical centres and formulation experts, IMCD delivers intelligent solutions that solve complex challenges – including solubility enhancement, modified release, and taste masking. Attendees will discover innovative prototypes such as dual-layer tablets, high-load capsules, and advanced coating systems.</li></ul> <ul class="wp-block-list"><li><strong>Patient-centric</strong>: Formulation concepts designed with the end-user in mind. Whether it’s improving compliance through palatable paediatric formats or enhancing bioavailability for chronic therapies, IMCD will showcase patient-focused solutions that are safer, more effective, and easier to take.</li></ul> <p>At the booth, IMCD experts will present <strong>six innovative concepts</strong>, each demonstrating the company’s ability to combine regulatory insight with formulation excellence to support the rapid development of high-value therapies:</p> <ul class="wp-block-list"><li><strong>Apixaban coated tablet</strong> – A more sustainable alternative to traditional roller compaction. The direct compression formulation reduces manufacturing steps, energy use, and cleaning, while maintaining comparable performance to the originator.</li></ul> <ul class="wp-block-list"><li><strong>Apremilast ointment</strong> – A novel, more patient-friendly topical treatment concept for psoriasis that enhances API solubility and skin permeation, offering a non-greasy, easy-to-apply formulation free from the side effects of oral therapy.</li></ul> <ul class="wp-block-list"><li><strong>Caffeine SR effervescent tablet</strong> – A dual-release concept combining immediate and sustained caffeine delivery for long-lasting energy without the “crash,” with taste masking and effervescent convenience that promote hydration and compliance.</li></ul> <ul class="wp-block-list"><li><strong>Ginkgo coated tablet</strong> – A direct compression, once-a-day liposomal ginkgo biloba tablet that improves absorption, ensures stability, and delivers performance in a small, easy-to-swallow format.</li></ul> <ul class="wp-block-list"><li><strong>Terbinafine film forming solution</strong> – A transparent, water-resistant film that provides prolonged antifungal action with a pleasant, non-tacky feel, for an advanced, patient-friendly approach to treating athlete’s foot.</li></ul> <ul class="wp-block-list"><li><strong>Mucoadhesive gel platform</strong> – A versatile platform for targeted, patient-centric drug delivery across oral, buccal, vaginal, and other mucosal routes, extending retention time and offering new opportunities for differentiation and patient comfort.</li></ul> <p>More information are available on our dedicated page <a href="https://link.mediaoutreach.meltwater.com/ls/click?upn=u001.dGXcScUs4v-2FMAecsBUXk4cN4Y-2BUpe-2FDv8Tofj-2B2USWjiUR-2BAE-2Br9XxQ6811yLiVNleVzx40BOvkkJYMGEvM0LH-2BmiukPD3hueKYcSGwUvzuVyLk7tFPkxb0mKPDhUKpHsCE2bCxVTulTWGhNvKCGim-2BK5ELrSzbGZ9NNZdtIS-2BJxBKyMJhg-2BnehN4wY29r0RhNISALiw7NokGroVvJY4KKlOPyEXnvJPl-2F9TcVvFOlNKZK4mIntP2Rs03tlFJmR20yZ1hVpDj3GV6EjTBlQ89Q-3D-3Ddfd7_W9TbS1CN6YS-2FwqlpgWOZKXpfi8Zkj-2FqnrATmwh7Wmo9NZ9inv1AJS2oZAdu8T5SesISNh69hy-2Fgp2MIGgDD6wpCNsArCwSxt1mZxc9rUg6FMXHD67CAc2flZLmwep8oj7Bpb495MBEr4B4QPoruAtbBhcMCBYYd-2FFsOkJkQMQeBOGqsZjfuTSCQ4AazIc1TMwvWbkwcPIWf4N5h8vTUSP7xzJ7sQ2SwjYeQa39QE68BLrQrO5EzchvxMD5LMhj9jCv6quF8yFXE27YOnVRjzoSG1qtACzx-2F0o30lqo3Xt-2B7ElbPF3a9qMf2z1w1M0klOJ9d3NDn8ACv2b0d4iZjwlop6SF0gys9W9xBcWPCXFJJB4JDDQSoOYbJul3JB3ibi" target="_blank" rel="noreferrer noopener"><strong>here</strong></a>.</p> <p><strong>Chhanda Kapadia</strong>, Group Director, Technical Services, IMCD<strong> </strong>Pharmaceuticals, comments: <em>“Our presence at CPHI reflects our commitment to co-creating solutions that are not only innovative but also more sustainable and patient focused. They are a first-class example of our globally connected network of technical laboratories. We are looking forward to showcasing these innovations and engaging with partners and customers to explore how we can shape the future of healthcare together”.</em></p> <p>IMCD invites visitors to <strong>Booth 8.0S36 </strong>to meet its technical experts and explore how its tailored solutions can help bring better medicines to market.</p> <figure class="wp-block-image"><img decoding="async" src="https://meltwater-apps-production.s3.eu-west-1.amazonaws.com/uploads/images/565c32b917106f965e0c81b0/1761226804116/image_47551308841761226803983.jpg" alt="A person looking through a microscopeAI-generated content may be incorrect."/></figure> <p>IMCD Laboratory in Cologne, Germany (photo: IMCD)</p> <figure class="wp-block-image"><img decoding="async" src="https://meltwater-apps-production.s3.eu-west-1.amazonaws.com/uploads/images/565c32b917106f965e0c81b0/1761226804117/image_31700315551761226803987.jpg" alt="A room with tables and chairsAI-generated content may be incorrect."/></figure> <p>IMCD booth at CPHI Milan 2024 (photo: IMCD)</p>]]></content:encoded> </item> <item> <title>OMED Health Partners with Aviva to Support the Digestive Health of Employees</title> <link>https://international-biopharma.com/omed-health-partners-with-aviva-to-support-the-digestive-health-of-employees/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 23 Oct 2025 15:36:16 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18202</guid> <description><![CDATA[OMED Health (“OMED”), a UK-based business pioneering non-invasive breath analysis for gut health and part of Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced a pilot as part of its longstanding collaboration with Aviva, the UK’s leading diversified insurer. The pilot, involving 75 Aviva […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>75 Aviva employees to gain pilot access to doctor-led OMED Health Plans, which include the use of the OMED Health Breath Analyzer and mobile app</em></li> <li><em>Collaboration will evaluate the impact of the OMED solution on the digestive health and quality of life of participants in a workplace setting </em></li></ul> <p></p> <p>OMED Health (“OMED”), a UK-based business pioneering non-invasive breath analysis for gut health and part of Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy<sup>® </sup>for applications in early disease detection and precision medicine, today announced a pilot as part of its longstanding collaboration with Aviva, the UK’s leading diversified insurer.</p> <p>The pilot, involving 75 Aviva employees, intends to demonstrate the value of the OMED Health solution in a workplace setting by addressing the significant impact of gastrointestinal (GI) conditions on employee health and workplace productivity. The study is expected to be completed within six months.</p> <p>The pilot group of Aviva employees will receive access to OMED Health Plans<sup> 1</sup>, a CQC-registered service that guides individuals through personalized care pathways, including treatments and custom diet plans and supported by consultations with a licensed Owlstone medical doctor, to help them to gain control over their GI symptoms or conditions. Each participant will also receive an OMED Health Breath Analyzer, a handheld medical device that accurately measures gases related to the microbiome, and a linked mobile app<sup>2</sup> which collects vital symptom and dietary data. The Analyzer will be used to track progress through the pilot, and surveys will be provided to participants prior to and following the pilot to determine the direct impact of the Health Plan on their gut health and quality of life.</p> <p>Functional gut disorders such as Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and food intolerances affect up to 1 in 8 people globally<sup>3</sup>, and in the UK alone 17% of adults have IBS or another form of GI disease<sup>4</sup>. Unfortunately, while there are many potential causes, symptoms can be non-specific and so many suffer for years without a clear resolution, impacting every aspect of normal life at home and at work.</p> <p>The broader implications of poor digestive health are significant. In the UK, direct costs of IBS alone are estimated at over £2 billion<sup>5</sup> per year with indirect costs twice this amount<sup>6</sup>. Gut health issues are also a leading cause of workplace absenteeism, with sufferers requiring almost twice as many days off work, and even when present average productivity is 30% lower<sup>6</sup>. Addressing these conditions by helping those living with digestive disease to find and fix their specific problems is therefore crucial both to support employees and to reduce the economic impact.</p> <p>This initiative strongly supports the “Fit for the Future: 10 Year Health Plan for England”<sup>7</sup>, which outlines three radical shifts for the NHS: from sickness to prevention, from analogue to digital, and from hospital to community. By improving employee health and reducing absenteeism, adoption of the OMED Health solution has the potential to contribute to the broader NHS ambition of enhancing productivity and supporting economic growth, while reducing the burden on the NHS by decreasing unnecessary visits to traditional healthcare settings through at-home diagnosis and management of disease.</p> <p>Aviva Ventures, Aviva Investors’ venture capital arm, first invested in Owlstone Medical in 2017, with Aviva Investors also having made an additional investment through its dedicated Venture & Growth Capital strategy, reflecting the company’s broader commitment to backing innovative technologies that improve health outcomes.</p> <p><strong>Ant Barker, Director of Venture Capital at Aviva Investors, commented:</strong> <em>“As well as being an investor in Owlstone, Aviva is committed to supporting the wellbeing of our employees and we’re pleased to offer this unique opportunity for our colleagues to play a role in medical developments. Digestive health issues can be incredibly disruptive, impacting daily life and professional performance, and so are gaining increased attention as part of employee wellness efforts. Owlstone’s innovative approach has the potential to transform how these conditions are understood and managed, and we’re excited to support their journey through this pilot initiative.”</em></p> <p><strong>Billy Boyle, co-founder and CEO at Owlstone Medical, said:</strong> <em>“OMED Health was founded to better the diagnosis and management of digestive health by providing patients and doctors with access to transformational breath-based solutions and clinical care, meaningfully improving patients’ quality of life, both at work and at home. We intend for the OMED solution to become part of the standard of care, either from ourselves or through license partners, and are grateful to Aviva for the support and funding provided for this study which will help us to advance towards this goal.”</em></p> <ol class="wp-block-list"><li><a href="https://omedhealth.com/our-treatments-services/" target="_blank" rel="noreferrer noopener">https://omedhealth.com/our-treatments-services/</a> </li> <li><a href="https://omedhealth.com/" target="_blank" rel="noreferrer noopener">https://omedhealth.com/</a></li> <li><a href="https://gutscharity.org.uk/advice-and-information/conditions/irritable-bowel-syndrome/" target="_blank" rel="noreferrer noopener">https://gutscharity.org.uk/advice-and-information/conditions/irritable-bowel-syndrome/</a></li> <li><a href="https://www.bjmp.org/content/irritable-bowel-syndrome-primary-care-physicians" target="_blank" rel="noreferrer noopener">https://www.bjmp.org/content/irritable-bowel-syndrome-primary-care-physicians</a></li> <li><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC6689327/" target="_blank" rel="noreferrer noopener">https://pmc.ncbi.nlm.nih.gov/articles/PMC6689327/</a></li> <li>Allergan IBS Global Impact Report</li> <li><a href="https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future" target="_blank" rel="noreferrer noopener">https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future</a></li></ol>]]></content:encoded> </item> <item> <title>Biodesix Announces Expanded Bio-Rad Laboratories Partnership Agreement to Develop Droplet Digital™ PCR High Complexity Assays</title> <link>https://international-biopharma.com/biodesix-announces-expanded-bio-rad-laboratories-partnership-agreement-to-develop-droplet-digital-pcr-high-complexity-assays/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 23 Oct 2025 15:09:06 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18200</guid> <description><![CDATA[Biodesix will perform the clinical validation of ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing Biodesix, Inc., a leading diagnostics solutions company, today announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of […]]]></description> <content:encoded><![CDATA[<p></p> <p>Biodesix will perform the clinical validation of ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing</p> <p>Biodesix, Inc., a leading diagnostics solutions company, today announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of <em>in vitro</em> diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications, utilizing Bio-Rad’s Droplet Digital<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> PCR (ddPCR<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" />) technology on Bio-Rad’s QX600 platform. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.</p> <p>The first assays to be validated under the agreement include Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay. ESR1 testing is becoming critical in HR+/HER2- advanced breast cancer due to the clinically demonstrated survival benefits from a new generation of therapy called oral selective estrogen receptor degraders (SERDs). The ddPLEX ESR1 Mutation assay will enable highly sensitive detection and absolute quantification of multiple ESR1 mutations from ctDNA samples.</p> <p>Once validated, the ESR1 assay will be offered as a test service at Biodesix’ accredited CLIA-CAP laboratory for biopharma customers to support the development of targeted therapeutics, as well as for clinical customers to support cancer treatment monitoring. Biodesix will also seek reimbursement for this assay through Centers for Medicare & Medicaid Services (CMS).</p> <p>“The emergence of ESR1 mutations as biomarkers for breast cancer has had a significant impact on the oncology market, leading to an increased global demand for rapid, sensitive assays,” <strong>said Scott Hutton, CEO, Biodesix.</strong> “We are proud to expand our partnership with Bio-Rad through this new agreement, demonstrating how our combined capabilities in mutation detection can address clinical needs with speed and precision, and opening doors to personalized, data-driven medicine.”</p> <p>“Through our long-standing relationship with Biodesix we have effectively delivered both clinical and research-based applications of our ddPCR technology for non-small cell lung cancer, as part of its Lung Diagnostics portfolio,” <strong>commented Steve Kulisch, VP Product Management, Life Science Group, Bio-Rad Laboratories. </strong>“Validation of our ddPLEX ESR1 kits will further expand our combined capabilities in clinical diagnostics, increasing access to sensitive biomarker detection for advanced breast cancer.”</p> <p>At the upcoming <a href="https://amp25.amp.org/" target="_blank" rel="noreferrer noopener">AMP conference, Nov 11-15, Boston, MA</a>, both companies will be providing more detail on their R&D visions, partnerships, and commercial roadmaps:</p> <ul class="wp-block-list"><li>Bio-Rad Laboratories <a href="https://amp25.amp.org/corporate-workshops/attend-a-corporate-workshop/" target="_blank" rel="noreferrer noopener">Corporate Workshop</a>, Nov 12, at 8 am</li> <li>Biodesix <a href="https://amp25.amp.org/corporate-workshops/attend-a-corporate-workshop/" target="_blank" rel="noreferrer noopener">Corporate Workshop</a>, Nov 12, at 4 pm</li></ul> <p><strong>About Biodesix</strong></p> <p>Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. <strong>Biodesix Diagnostic Tests</strong>, marketed as Nodify Lung<sup>®</sup> Nodule Risk Assessment and IQLung<sup>®</sup> Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. <strong>Biodesix Development Services</strong> enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit <a href="https://www.biodesix.com/" target="_blank" rel="noreferrer noopener">biodesix.com</a>.</p> <p><strong>Contacts:</strong></p> <p><strong>Media:</strong></p> <p>Natalie St. Denis, Director Corporate Communications, Biodesix</p> <p><a>natalie.stdenis@biodesix.com</a></p> <p>(720) 925-9285</p> <p>Zyme Communications (Bio-Rad PR firm)</p> <p>Dr. Maria Spyrou</p> <p>+44 (0) 7707 049 640</p> <p><a>maria.spyrou@zymecommunications.com</a></p> <p><strong>Investors:</strong></p> <p>Chris Brinzey, Partner, ICR</p> <p><a>chris.brinzey@icrhealthcare.com</a></p> <p>(339) 970-2843</p>]]></content:encoded> </item> <item> <title>ProImmune Expands into New 18,000 sq ft Global Headquarters Enabling Major Expansion in Immunology and Life Science Innovation</title> <link>https://international-biopharma.com/proimmune-expands-into-new-18000-sq-ft-global-headquarters-enabling-major-expansion-in-immunology-and-life-science-innovation/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 23 Oct 2025 12:49:52 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18198</guid> <description><![CDATA[ProImmune Ltd, a global leader in life science reagents and services, today announced the opening of its new global headquarters building at Oasis Park, Oxford, enabling significant expansion of its operations and capacity to serve its global client base. Located within Oxford’s renowned bioscience and innovation ecosystem, the 70,000 sq ft Oasis Park is already […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>Move follows ProImmune’s recent acquisition of Oasis Park a 70,000 sq ft Business and Light Industrial Park in Oxford, UK</em></li> <li><em>Increased operational capacity enables accelerated development of ProImmune’s REVEAL<sup>®</sup> Immunogenicity System and Ankyron<sup>®</sup> target binding technologies</em></li></ul> <p></p> <p>ProImmune Ltd, a global leader in life science reagents and services, today announced the opening of its new global headquarters building at Oasis Park, Oxford, enabling significant expansion of its operations and capacity to serve its global client base.</p> <p>Located within Oxford’s renowned bioscience and innovation ecosystem, the 70,000 sq ft Oasis Park is already home to six existing tenants. ProImmune’s new 18,000 sq ft main headquarters facility represents a substantial investment in state-of-the-art laboratories, providing ProImmune with the space and infrastructure to accelerate innovation in the REVEAL<sup>®</sup> Immunogenicity System, its suite of assay services to help understand immune responses to vaccines and therapeutic products, and the expansion of the Company’s revolutionary Ankyron<sup>®</sup> target binding reagent platform. Ankyrons are small, recombinant, target binding ankyrin repeat proteins, developed by ProImmune to overcome challenges in in antibody research. The high-specificity, sensitivity, and reproducibility of Ankyrons offers a cost-effective alternative to generating custom antibodies.</p> <p><em>“Our new global headquarters at Oasis Park, Oxford, are a reflection of ProImmune’s commitment to scientific excellence in immunology and global one-health biology,”</em> <strong>said Dr. Nikolai Schwabe, Chief Executive Officer of ProImmune</strong>. <em>“The investment into the park, and into our new flexible laboratory and office facilities, strengthens our ability to deliver world-class products and services, supporting our partners to develop safer and more effective therapies for patients around the world</em>.”</p>]]></content:encoded> </item> <item> <title>SGD Pharma presents new innovations at CPHI Frankfurt 2025, underscoring its leadership in sustainability and technological excellence</title> <link>https://international-biopharma.com/sgd-pharma-presents-new-innovations-at-cphi-frankfurt-2025-underscoring-its-leadership-in-sustainability-and-technological-excellence/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 23 Oct 2025 09:06:00 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18196</guid> <description><![CDATA[SGD Pharma, a global leader in pharmaceutical glass primary packaging solutions, will showcase its enhanced portfolio of products and services at booth 8.0H24 during CPHI, taking place in Frankfurt, Germany, from 28th to 30rd October 2025. As part of the company’s strategic growth plan to expand its tubular glass offering in Europe, SGD Pharma has significantly reinforced its industrial and commercial […]]]></description> <content:encoded><![CDATA[<p></p> <p>SGD Pharma, a global leader in pharmaceutical glass primary packaging solutions, will showcase its enhanced portfolio of products and services at <strong>booth 8.0H24 </strong>during <strong>CPHI</strong>, taking place in Frankfurt, Germany, from <strong>28<sup>th</sup> to 30<sup>rd</sup> October 2025</strong>.</p> <p>As part of the company’s strategic growth plan to expand its tubular glass offering in Europe, SGD Pharma has significantly reinforced its industrial and commercial footprint with the acquisition of Alphial S.r.l, a tubular glass converting company manufacturing ampoules, vials and Ready to Use (RTU) products. This move positions SGD Pharma as a key player in the tubular segment as well as its leadership in molded, enabling greater responsiveness, increased capacity, and innovation tailored to the evolving needs of the European pharma market. The acquisition of Alphial will ideally complement the company’s existing operations in Europe and tubular facility in Vemula, India, recently bolstered by a joint venture with Corning. Alphial will also be attending CPHI, find out more about how the expansion is reshaping tubular glass packaging at booth 8.0G1.</p> <p>New for CPHI 2025, SGD Pharma continues to lead with its flagship <strong>Sealian</strong> platform. This internal surface treatment for molded glass vials creates a strong barrier coating that protects sensitive therapeutics, improves chemical durability (especially against alkaline solutions), and reduces interactions between drug products and packaging. Sealian is available in clear and amber glass for vial sizes, ranging from <strong>3 ml to 500 ml</strong> and is suited for every route of administration (parenteral, oral, nasal).</p> <p>Also on display at CPHI 2025:</p> <ul class="wp-block-list"><li><strong>IDENCY</strong>: now fully completed range of vials in <strong>6 ml, 10 ml and 20 ml</strong>, combining the chemical and mechanical resistance of molded glass with external dimensions comparable with standard tubular glass for fill & finish lines.</li> <li><strong>Sterinity EZ-fill<sup>®</sup></strong>: SG EZ-Fill’s ready-to-use (RTU) molded glass vials, offering sterile, flexible and high-quality solutions.</li> <li><strong>Ensiemo</strong>: the full pharma-grade Type III vial and pipette packaging system, now available with tamper-evident and child-resistant caps.</li> <li><strong>Velocity<sup>®</sup> Vials</strong>: SGD Pharma’s Type I tubular glass vials with external low-friction coating from Corning, designed to optimize fill & finish operations — reducing friction, improving throughput (20‑50 % efficiency gains), lowering particulate generation by up to 96 %.</li></ul> <p>Newly at CPHI, SGD Pharma also introduces <strong>Proseal+</strong>, an advanced external treatment for molded and tubular vials that enhances moisture and oxygen protection to extend shelf life of pharmaceutical contents.</p> <p><br>Further strengthening its service offering, SGD Pharma’s newly launched <strong>Lab Services</strong> are fully operational, delivering analytical testing to pharma/biopharma companies, CMOs/CDMOs, and other glass packaging players. More expansions to the Lab Services offering are expected in 2026.</p> <p>Regarding its latest sustainable initiatives, SGD Pharma has updated its emissions targets: compared to 2022 levels, the company is targeting a <strong>42 % reduction by 2030</strong> and <strong>65 % by 2040</strong>. The group has been awarded <strong>Platinum status by EcoVadis in 2025</strong>, reflecting top-tier ESG performance among glass manufacturers.</p> <p>Olivier Rousseau, CEO of SGD Pharma states:</p> <p><em>“At CPHI 2025, we are proud to mark a major milestone in our growth strategy with the acquisition of Alphial. This integration strengthens our industrial footprint across Europe and supports our ambition to expand our offering to better serve the evolving needs of our pharmaceutical partners, in flexibility, safety, and speed. From Sealian to Velocity, every innovation also reflects our strong commitment to sustainability.”</em></p> <p>Visit us at <strong>booth 8.0H24 </strong>to see these innovations in person and learn how SGD Pharma can support your requirements while raising the bar for performance and sustainability.</p>]]></content:encoded> </item> <item> <title>Enamine contributes to the discovery of promising broad-spectrum coronavirus antiviral</title> <link>https://international-biopharma.com/enamine-contributes-to-the-discovery-of-promising-broad-spectrum-coronavirus-antiviral/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Thu, 23 Oct 2025 08:54:26 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18194</guid> <description><![CDATA[Enamine, a leading chemistry and R&D services company, today announced that it was a key synthetic chemistry contributor to a first-of-its-kind, open-science approach that led to the development of a promising broad-spectrum coronavirus antiviral pre-clinical candidate. Enamine’s chemistry platform delivered over 2,000 new compounds during the early stages of the programme that resulted in the discovery of […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><em>Open-science research initiative, COVID Moonshot and the AI-driven Structure-enabled Antiviral Platform (ASAP) consortium, delivered a promising pre-clinical candidate </em></li> <li><em>2,000 new compounds generated for the programme are now available from Enamine’s catalogue</em></li></ul> <p></p> <p>Enamine, a leading chemistry and R&D services company, today announced that it was a key synthetic chemistry contributor to a first-of-its-kind, open-science approach that led to the development of a promising broad-spectrum coronavirus antiviral pre-clinical candidate. Enamine’s chemistry platform delivered over 2,000 new compounds during the early stages of the programme that resulted in the discovery of pre-clinical candidate ASAP-0017445. The candidate is designed to be a direct-to-generic, globally accessible treatment ready for future coronavirus pandemics.</p> <p>The pre-clinical drug candidate ASAP-0017445, which exhibited encouraging preliminary safety and efficacy results, was recently nominated by Drugs for Neglected Diseases initiative (DNDi), a non-profit medical research organisation, as a highly effective antiviral for coronaviruses<sup>[1]</sup>. The drug was developed by the COVID Moonshot and ASAP (AI-driven Structure-enabled Antiviral Platform) Discovery Consortium, formed during the COVID-19 pandemic, of which Enamine is a member from the early days. The consortia aimed to accelerate open-science antiviral drug discovery and deliver oral antivirals to prevent future pandemics. Enamine played a pivotal role in the early stages of the COVID Moonshot programme, enabling rapid production of novel molecules, compound management, and logistics, which significantly accelerated the discovery cycle. The Company also performed Tier 1 ADME tests in close proximity to the compound depository, which was essential in shortening Design-Make-Test-Analyse cycles. Further optimisation of the lead series of compounds produced by Enamine was conducted by MedChemica, resulting in the development of ASAP-0017445<em>.</em></p> <p>“<em>We are proud to have been a part of this groundbreaking open science collaboration, where researchers from across the world have come together to advance vital drug discovery efforts. We are grateful to all the other organisations who played a part in contributing to the global effort to strengthen resilience against future pandemics,</em>” <strong>said Vladimir Ivanov, Executive Vice President of Enamine.</strong></p> <p>The structure of ASAP-0017445 was publicly disclosed in March 2025<sup>[2]</sup>. The patent<sup>[3]</sup> and all data generated during the compound’s development have recently been published to support the open science approach. All 2,000 compounds generated during this collaboration are now available from Enamine’s catalogue.</p> <p><strong>References:</strong></p> <p>[1] – <a href="https://dndi.org/press-releases/2025/open-science-approach-delivers-preclinical-candidate-broad-spectrum-coronavirus-antiviral/" target="_blank" rel="noreferrer noopener">Open-science approach delivers a promising pre-clinical candidate for broad-spectrum coronavirus antiviral | DNDi</a></p> <p>[2] – <a href="https://cen.acs.org/acs-news/acs-meeting-news/Antiviral-unveiled-goes-multiple-coronaviruses/103/web/2025/03" target="_blank" rel="noreferrer noopener">https://cen.acs.org/acs-news/acs-meeting-news/Antiviral-unveiled-goes-multiple-coronaviruses/103/web/2025/03</a></p> <p>[3] – <a href="https://patentscope.wipo.int/search/en/WO2025125695" target="_blank" rel="noreferrer noopener">https://patentscope.wipo.int/search/en/WO2025125695</a></p>]]></content:encoded> </item> <item> <title>Bruker Announces FDA Clearance of Claims 7 and 8 for theMALDI Biotyper® CA System, Expanding Diagnostic Capabilities</title> <link>https://international-biopharma.com/bruker-announces-fda-clearance-of-claims-7-and-8-for-themaldi-biotyper-ca-system-expanding-diagnostic-capabilities/</link> <dc:creator><![CDATA[Alice Phillips]]></dc:creator> <pubDate>Mon, 20 Oct 2025 12:25:22 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=18189</guid> <description><![CDATA[At the annual IDWeek meeting (https://idweek.org/), Bruker announced the U.S. Food and Drug Administration (FDA) clearance of Claim 7 and Claim 8 for its MALDI Biotyper® CA System, marking a significant advancement in clinical microbial identification capabilities. The clearance includes the MBT Compass HT CA software and MBT FAST™ Shuttle US IVD (Claim 7), as well as a major expansion of the […]]]></description> <content:encoded><![CDATA[<p></p> <ul class="wp-block-list"><li><strong><em>Claim 7: FDA clearance of MBT FAST<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Shuttle US IVD and MBT Compass HT CA software improves workflow efficiency and accelerates data processing.</em></strong></li> <li><strong><em>Claim 8: FDA approval of expanded reference library increases coverage to 549 validated microbial species.</em></strong></li></ul> <p></p> <p>At the annual <strong>ID</strong>Week meeting (<a href="https://idweek.org/" target="_blank" rel="noreferrer noopener">https://idweek.org/</a>), Bruker announced the U.S. Food and Drug Administration (FDA) clearance of Claim 7 and Claim 8 for its <strong>MALDI Biotyper<sup>®</sup> CA System</strong>, marking a significant advancement in clinical microbial identification capabilities. The clearance includes the <strong>MBT Compass HT CA</strong> software and <strong>MBT FAST<img src="https://s.w.org/images/core/emoji/16.0.1/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Shuttle US IVD</strong> (Claim 7), as well as a major expansion of the FDA-cleared reference library (Claim 8), now encompassing 549 clinically validated microbial species across gram-positive and gram-negative bacteria, anaerobes and yeasts.</p> <p><strong>Technology Enhancements</strong></p> <p> The MALDI Biotyper CA System is a mass spectrometry-based platform that uses MALDI-TOF technology for rapid identification of microorganisms following culture from human specimens, either from isolated colonies or positively flagged blood cultures. With the newly cleared MBT Compass HT CA software, laboratories benefit from enhanced performance, including parallel data processing, improved user management, and support for 21 CFR Part 11 compliance. It also features IDealTune, an automated tuning function that maintains optimal system performance by continuously monitoring the US IVD Bacterial Test Standard quality control results. This reduces the need for manual tune-ups and ensures consistent diagnostic reliability over extended periods.</p> <p>The MBT FAST Shuttle US IVD enables accelerated drying of droplets, including MALDI matrix, hence significantly reducing sample preparation time as compared to room temperature drying. In addition to speed, it also standardizes sample preparation, resulting in reproducible matrix crystallization – a critical factor in MALDI-TOF analysis. This consistency further improves sample preparation quality which can contribute to more reliable and accurate identification results.</p> <p><strong>Expanded Diagnostic Reach</strong></p> <p> The FDA-cleared reference library now includes reference spectra of 549 clinically validated microbial species in 437 groups, covering gram-positive and gram-negative bacteria, anaerobes, and yeasts. Additionally, the system includes over 3400 non-clinically validated species, which are clearly marked in reports to guide alternate identification methods. These results are not transmitted to the laboratory information system, ensuring clarity and compliance in reporting.</p> <p><strong>Outlook</strong></p> <p>Looking ahead, Bruker is finalizing internal processes to prepare for shipment of the updated MALDI Biotyper CA System in the U.S. and Puerto Rico. In addition to new system deliveries, current users of the MALDI Biotyper CA System can also benefit from the newly FDA-cleared features – the updated reference library, MBT FAST Shuttle US IVD, and MBT Compass HT CA software – to expand the capabilities of their existing systems. The company continues to invest in expanding its validated library and software capabilities, with future claims expected to further enhance diagnostic reach and efficiency.</p> <figure class="wp-block-image size-full"><img fetchpriority="high" decoding="async" width="332" height="513" src="https://international-biopharma.com/wp-content/uploads/2025/10/MALDI-Biotyper-sirius-CA-system.png" alt="" class="wp-image-18190" srcset="https://international-biopharma.com/wp-content/uploads/2025/10/MALDI-Biotyper-sirius-CA-system.png 332w, https://international-biopharma.com/wp-content/uploads/2025/10/MALDI-Biotyper-sirius-CA-system-194x300.png 194w" sizes="(max-width: 332px) 100vw, 332px" /></figure> <figure class="wp-block-image size-full"><img decoding="async" width="379" height="290" src="https://international-biopharma.com/wp-content/uploads/2025/10/MBT-FAST-Shuttle-US-IVD.png" alt="" class="wp-image-18191" srcset="https://international-biopharma.com/wp-content/uploads/2025/10/MBT-FAST-Shuttle-US-IVD.png 379w, https://international-biopharma.com/wp-content/uploads/2025/10/MBT-FAST-Shuttle-US-IVD-300x230.png 300w" sizes="(max-width: 379px) 100vw, 379px" /></figure>]]></content:encoded> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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