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	<title>Biose Industrie</title>
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	<description>Your global CDMO for Microbiome Therapeutics</description>
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		<title>Field Notes from Copenhagen: Our highlights from the 2026 Microbiome Times Partnering Forum Europe</title>
		<link>https://www.biose.com/field-notes-from-copenhagen-our-highlights-from-the-2026-microbiome-times-partnering-forum-europe/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Tue, 28 Apr 2026 08:20:33 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=30354</guid>

					<description><![CDATA[<p>By Jean-Baptiste Doucet  &#124;  April 2026 LBP Program Leader at Biose Industrie Most of my week looks like batch planning, client timelines, and coordinating between our teams and the developers [&#8230;]</p>
<p>The post <a href="https://www.biose.com/field-notes-from-copenhagen-our-highlights-from-the-2026-microbiome-times-partnering-forum-europe/">Field Notes from Copenhagen: Our highlights from the 2026 Microbiome Times Partnering Forum Europe</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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										<content:encoded><![CDATA[<p><strong>By Jean-Baptiste Doucet  |  April 2026</strong></p>
<div class="cbd4d72a a420381b _9084e637 eeb00d88 bfddfbc5 _883b96c8">
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<p class="d5431a5b _1ab16eed c21f445a cacb1a09 a6e178b5 d6803a9f _034443af _28f76e84 a163d908 d6b6ba7f _721f82fb">LBP Program Leader at Biose Industrie</p>
<p><img decoding="async" class="alignnone wp-image-30363" src="https://www.biose.com/wp-content/uploads/2026/04/ba-modified-300x300.png" alt="" width="105" height="105" srcset="https://www.biose.com/wp-content/uploads/2026/04/ba-modified-300x300.png 300w, https://www.biose.com/wp-content/uploads/2026/04/ba-modified-150x150.png 150w, https://www.biose.com/wp-content/uploads/2026/04/ba-modified-96x96.png 96w, https://www.biose.com/wp-content/uploads/2026/04/ba-modified.png 320w" sizes="(max-width: 105px) 100vw, 105px" /></p>
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<p>Most of my week looks like batch planning, client timelines, and coordinating between our teams and the developers we work with. That is the project manager&#8217;s world at a CDMO like Biose, and I am generally comfortable in it.</p>
<p>Copenhagen was a good reason to step out of it.</p>
<p>The 2026 <a href="https://www.microbiomeforum.com/">Microbiome Times Partnering Forum Europe</a> brought together two full days of presentations spanning Harvard research labs, clinical-stage start-ups, investor perspectives, and a few genuine surprises &#8211; including a session on gut bacteria that absorb PFAS, and another on soil consortia improving crop yields. I went as a listener &#8211; curious, not expert. Here is what stood out.</p>
<h3></h3>
<p><img fetchpriority="high" decoding="async" class="wp-image-30367 size-large aligncenter" src="https://www.biose.com/wp-content/uploads/2026/04/1000141986-1024x473.jpg" alt="" width="640" height="296" srcset="https://www.biose.com/wp-content/uploads/2026/04/1000141986-1024x473.jpg 1024w, https://www.biose.com/wp-content/uploads/2026/04/1000141986-300x139.jpg 300w, https://www.biose.com/wp-content/uploads/2026/04/1000141986-768x355.jpg 768w, https://www.biose.com/wp-content/uploads/2026/04/1000141986-1536x710.jpg 1536w, https://www.biose.com/wp-content/uploads/2026/04/1000141986-2048x946.jpg 2048w" sizes="(max-width: 640px) 100vw, 640px" /></p>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>From 100 subjects to 100,000</strong></em></span></h3>
<p>The opening panel set the tone. Four voices &#8211; Denise Kelly of <a href="https://www.seventure.fr/en/">Seventure Partners</a>, Curtis Huttenhower from <a href="https://www.harvard.edu/">Harvard</a>, Jeroen Raes from <a href="https://www.kuleuven.be/english/kuleuven">KU Leuven</a>, and Seth Bordenstein from <a href="https://www.psu.edu/">Penn State</a> &#8211; were each asked to say where they think the microbiome field actually stands today.</p>
<p>Raes put it in numbers: from MetaHIT cohorts of around 100 subjects fifteen years ago to studies now reaching 100,000 participants. The field has moved from a community under construction to one entering a serious validation phase &#8211; clinical and preclinical data converging, AI and machine learning increasingly used to turn associations into something closer to causality.</p>
<p>Bordenstein added a dimension worth noting: the next wave goes beyond human health. A One Health framework &#8211; where host, microbiome and environment are studied as a system, not separate chapters. Two examples he gave: oral microbiome transplants being explored to prevent dental caries, and Wolbachia-based approaches to disrupt mosquito-borne viral transmission. Neither felt far away.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em>The question is no longer just &#8216;what?&#8217; &#8211; it is &#8216;how?&#8217;</em></span></h3>
<p>One of the clearest threads across the two days was the shift from composition to function. Huttenhower&#8217;s standalone session opened with a figure worth sitting with: only around 25% of microbial genes are well annotated. The rest &#8211; a functional dark matter inside every gut microbiome &#8211; remains largely uncharacterised.</p>
<p>His team&#8217;s <a href="https://microbiome-bioactives.org/">Human Microbiome Bioactives Resource</a> (HMBR) is being built to address this. One application stood out: understanding why some IBD patients do not respond to 5-ASA, one of the most commonly prescribed treatments for ulcerative colitis. The answer, in many cases, is a microbial enzyme inactivating the drug before it can act. Identifying the organisms responsible opens the door to microbiome-aware prescribing.</p>
<p>Andrew Bartko from <a href="https://cmi.ucsd.edu/">UC San Diego&#8217;s Center for Microbiome Innovation</a> took a related angle. Around 25% of tested drugs are modified by gut microbial communities &#8211; via dihydroxylation, demethylation, hydrolysis, and other pathways. Donepezil in Alzheimer&#8217;s. 5-ASA in IBD. Knowing which organisms interfere, and how, could convert non-responders into responders without changing the molecule.</p>
<p><img decoding="async" class="wp-image-30368 size-large aligncenter" src="https://www.biose.com/wp-content/uploads/2026/04/1000141839-1024x473.jpg" alt="" width="640" height="296" srcset="https://www.biose.com/wp-content/uploads/2026/04/1000141839-1024x473.jpg 1024w, https://www.biose.com/wp-content/uploads/2026/04/1000141839-300x139.jpg 300w, https://www.biose.com/wp-content/uploads/2026/04/1000141839-768x355.jpg 768w, https://www.biose.com/wp-content/uploads/2026/04/1000141839-1536x710.jpg 1536w, https://www.biose.com/wp-content/uploads/2026/04/1000141839-2048x946.jpg 2048w" sizes="(max-width: 640px) 100vw, 640px" /></p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em>The clinical data is starting to arrive</em></span></h3>
<p>If there was one session that stopped the room, it was Nikole Kimes presenting results from <a href="https://www.sioltatherapeutics.com/">Siolta Therapeutics</a>&#8216; ADORED study. Their oral LBP candidate, STMC-103H, was given to at-risk infants over 336 days to prevent the atopic march &#8211; the sequential development of atopic dermatitis, food allergy and asthma. Among infants who completed one year of treatment: a 64% reduction in the risk of physician-diagnosed atopic dermatitis (23.3% vs. 43.1% on placebo) and a 77% reduction in the risk of physician-diagnosed food allergy (4.7% vs. 16.7%). Good tolerability, no major safety signal. Numbers worth remembering.</p>
<p>The session that followed felt closer to home. Sam Possemiers of <a href="https://mrmhealth.com/">MRM Health</a> and Adrien Nivoliez, our CEO, took the stage together to present MH002 &#8211; and the eight years of industrial co-development that sit behind it.</p>
<p>MH002 is a live consortium of six commensal strains being developed for mild-to-moderate ulcerative colitis. Phase 2a results in 45 patients (randomised, double-blind, placebo-controlled, 8 weeks): clinical remission of 14% vs. 7% on placebo at week 8, and 18% vs. 0% in the per-protocol population. CRP normalisation in patients elevated at baseline: 60% vs. 25%. Faecal calprotectin normalisation: 36% vs. 15%. No antibiotic preconditioning required.</p>
<p>What makes this story worth telling &#8211; from where I sit at Biose &#8211; is not only the clinical signal, but the manufacturing story behind it. Producing six anaerobic strains as a single drug substance in co-culture, maintaining viability, purity and stability as you scale, is genuinely hard. Adrien walked through eight years of progressive development: fermentation to 2,000 litres at late GMP, specific analytical methods to identify and quantify each of the six strains separately, and a innovative delivery methods to protect the product and target the intestine. Phase IIb and then Phase III are next, with scale projected toward 5,000 litres. The industrial partnership starts on day one &#8211; not when the clinical trial is already running.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><em><span style="color: #873e90;"><strong>The gut-brain axis gets serious</strong></span></em></h3>
<p>The second afternoon gave considerable space to the gut-brain axis, and the perspective that stayed with me most came from Amy Kruse, Chief Investment Officer at <a href="https://www.satoricapital.com/neuro/">Satori Neuro</a>. Her message was straightforward: the space is gaining credibility not because the idea is new, but because the evidence is becoming cleaner. Biomarkers, mechanisms, a credible regulatory path &#8211; when those three are aligned, the field starts looking investable. The era of broad microbiome enthusiasm is over; what investors now want is specificity.</p>
<p><a href="https://bloomscience.com/">Bloom Science</a>&#8216;s Christopher Reyes backed it up with data. Their oral LBP candidate BL-001 is designed to reproduce the effects of a ketogenic diet through the microbiome, with applications in Dravet syndrome, other developmental and epileptic encephalopathies, and obesity. Phase 1 results in 32 adults showed good tolerability and, in overweight subjects, a placebo-adjusted average weight reduction of around 2.3% at day 28, with dose-dependent effects on metabolic markers consistent with the ketogenic hypothesis. Early data &#8211; but with a mechanism behind it.</p>
<p>Valerie Taylor of <a href="https://tayloredbio.com/">Taylored Biotherapeutics</a> added another angle: FMT trials in psychiatric disorders &#8211; bipolar disorder, OCD, depression &#8211; as a tool to identify which microbiomes are associated with treatment response, before moving toward a more defined microbial product. Around 80% response reported with FMT in bipolar disorder in their trial data. Eighteen candidate strains are now being evaluated for the next development stage. Still early. Still striking.</p>
<p>&nbsp;</p>
<h3><em><span style="color: #873e90;"><strong>The wider picture</strong></span></em></h3>
<p>Some of the sessions that stayed with me fell outside the more familiar therapeutic tracks &#8211; and they are worth noting.<br />
Yolanda Sanz from CSIC presented work linking a specific strain, Phascolarctobacterium faecium DSM 32890, to a favourable metabolic profile in human cohorts &#8211; less detected in obese subjects, with preclinical data showing reduced weight gain, adiposity and glucose intolerance in a high-fat diet mouse model. A small human study in overweight and obese subjects showed signals consistent with the preclinical data, though still very early stage. The next-generation probiotic space is moving toward strain-specific, mechanism-driven candidates &#8211; this felt like a good example of what that looks like in practice.</p>
<p>Kevin Horgan of <a href="https://www.mmblivebio.com/">Melius Microbiomics</a> presented a different kind of next-generation approach: genetically engineered microorganisms, using E. coli Nissle 1917 as a chassis. Their platform, BioPersist, transfers the ttr operon from Salmonella Typhimurium to improve colonisation in an inflammatory environment. Lead programme MMB-003 is in development for ulcerative colitis. The engineering is layered &#8211; better colonisation, targeted colonic delivery, and specific metabolic pathway modulation. Whether you find GEMMs straightforward or complex as a regulatory proposition, the science is serious.</p>
<p>Stephen Robinson from the <a href="https://quadram.ac.uk/">Quadram Institute introduced Bioscopic</a>, a UK spin-out developing therapeutic candidates from infant microbiota bacteria &#8211; specifically Bifidobacterium-derived compounds, not live bacteria themselves. Their lead, BIOS-001, is in preclinical development for immuno-oncology, showing around 50% reduction in tumour burden in breast cancer mouse models via dendritic cell activation and CD8 T-cell engagement. The active molecule appears to be a surface sugar from Bifidobacterium pseudocatenulatum. Still preclinical, but a genuinely different angle on what microbiome-derived therapeutics can look like.</p>
<p>Peter Holme Jensen of <a href="https://cambiotics.com/">Cambiotics</a> presented something that felt more consumer health than pharma, but which raised questions worth taking seriously: gut bacteria capable of accumulating PFAS &#8211; the &#8216;forever chemicals&#8217; present at measurable levels in most human populations. Their publicly reported strains show bioaccumulation of 25-74% of PFAS within minutes. A first human trial is planned for 2026. Whether or not this becomes a mainstream therapeutic direction, the underlying question &#8211; what else are commensal bacteria doing to environmental contaminants in our gut? &#8211; is a legitimate one.</p>
<p>Shelly Buffington from <a href="https://www.bcm.edu/about-us/bcm-innovation-institute">Baylor College of Medicine Ventures</a> presented work tracking the infant microbiome across the first six months of life and linking specific microbial and metabolite profiles to neurodevelopmental outcomes at age two. In a cohort of 35 infants with 123 faecal samples and Bayley scores at two years, her team identified a predictive metabolite and then designed a microbial intervention to increase it &#8211; achieving more than a three-fold increase in the target metabolite and observing behavioural improvement in animal models. A reminder that the earliest developmental windows may be where microbiome intervention has the most to offer.<br />
On the agritech side, Thomas Veje Flintegaard from <a href="https://collaborome.com/">Collaborome</a> presented soil bacterial consortia being tested as biopesticides against fungal crop disease &#8211; with yields of up to 25% higher under fungal pressure in field trials. Not the core focus of most people in the room, but a useful reminder of where the broader microbiome toolkit is heading.</p>
<p>&nbsp;</p>
<hr />
<p>Two days in Copenhagen. Thirty-plus sessions. The common thread was not a single breakthrough, but a field steadily building the evidence base it needs to move from promising to proven &#8211; across therapeutics, prevention, nutrition, and now further afield than most people in the room had perhaps expected.</p>
<p>From our side at Biose, the manufacturing takeaway is the one we hear most consistently from our partners: the path from a promising strain to a stable, scalable drug substance is longer and more complex than it looks from the outside. The Biose-MRM Health story is one illustration of what that journey looks like when it goes well.</p>
<p>If you were at the Forum and want to compare notes, or if you are working on an LBP programme and want to discuss what the science means for your manufacturing strategy, feel free to reach out.</p>
<p><em>The 2026 Microbiome Times Partnering Forum Europe was held in Copenhagen. For more information: <a href="https://www.microbiomeforum.com/">microbiomeforum.com</a></em></p>
<p>The post <a href="https://www.biose.com/field-notes-from-copenhagen-our-highlights-from-the-2026-microbiome-times-partnering-forum-europe/">Field Notes from Copenhagen: Our highlights from the 2026 Microbiome Times Partnering Forum Europe</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Bacterial count in next-generation probiotics: AFU technology</title>
		<link>https://www.biose.com/bacterial-count-in-next-generation-probiotics-afu-technology/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Tue, 03 Mar 2026 11:51:38 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=30226</guid>

					<description><![CDATA[<p>Classical methodologies and current limitations Switching from a liquid medium to sold agar plates in the early 1800s was a significant change for microbiology sciences. Operational standardisation of plate counting [&#8230;]</p>
<p>The post <a href="https://www.biose.com/bacterial-count-in-next-generation-probiotics-afu-technology/">Bacterial count in next-generation probiotics: AFU technology</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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										<content:encoded><![CDATA[<h3><span style="color: #873e90;"><em><strong>Classical methodologies and current limitations</strong></em></span></h3>
<p>Switching from a liquid medium to sold agar plates in the early 1800s was a significant change for microbiology sciences. Operational standardisation of plate counting evolved at such a rapid pace that it quickly became the default quality control (QC) method, allowing for better bacterial isolation and quantification, and significantly decreasing contamination rates in bacterial purification processes.</p>
<p><strong>Colony-forming units (CFU)</strong> counting constitutes a simple method widely found in current standards, which explains why it remains the current practice in Live Biotherapeutic Product (LBP) quality control protocols throughout the production and scaling processes worldwide &#8211; despite it first being introduced over 200 years ago.</p>
<p>However, despite its multiple benefits, CFU-counting methodologies have inherent constraints (time and strain-wise) that have become particularly obvious with the rise of modern microbiome products such as ‘Next Generation Probiotics’ (NGP).</p>
<p>Some of the <strong>limitations of CFU-based enumeration</strong> include:</p>
<ul>
<li><strong>Slow iteration:</strong> days-long incubation delays decisions during process development and troubleshooting.</li>
<li><strong>Undercounting or biased readings:</strong> some bacteria can enter a dormant but metabolically active state that will not form colonies in that specific culturing condition but might reactivate at a later stage. This state is known as ‘<em>viable but not culturable’ </em>(VBNC). As these bacteria do not properly form CFU, they can get lost throughout the isolation process, leading to falsely ignoring their presence in the original mix.</li>
<li><strong>Not fit-for-purpose for ‘next-generation’ strains:</strong> strict anaerobes and novel gut commensals can be difficult to culture consistently; in this context CFU counting becomes unsuitable as the sole enumeration method.</li>
</ul>
<p>Many NGP candidates are based on strict anaerobe strains, with demanding growth requirements; industrial production steps (concentration, freezing, drying, storage) can push cells into VBNC states. When strains are difficult to culture, and timelines are tight, the time needed to cultivate a colony can easily become a bottleneck.</p>
<p>At <strong>Biose Industrie</strong>, we understand this challenge, and as a CDMO specialising in both LBP and NGP development, we are deeply committed to bringing pharmaceutical-grade manufacturing discipline to difficult-to-culture organisms and complex production workflows, all the while staying abreast with the state-of-the-art technology.</p>
<h2></h2>
<p>&nbsp;</p>
<h2><span style="color: #873e90;"><em>Modern microbial characterisation: AFU technology</em></span></h2>
<p>While CFU-counting is the gold standard in microbial-based therapeutics regulatory standards, it is not the only available technique for bacterial characterisation. In the 1990s, <strong>flow cytometry (FCM)-based bacterial analysis</strong> arose as a faster alternative to CFU-counting, which bloomed in the 2000s with the development of different dyes used to discriminate between live and dead bacteria.</p>
<p>FCM bacterial characterisation has arisen as a robust alternative to overcome most of the limitations faced by CFU-counting for NGPs, especially since its international recognition in the regulatory landscape by <strong>ISO 19344 IDF 232</strong> for the quantification of active and/or total bacteria in probiotic products.</p>
<p>According to this regulation, cells are primarily stained with <strong>fluorescent dyes</strong> that allow for live/dead state discrimination, after which they are analysed in a one-by-one manner as they pass through a <strong>laser</strong>. Further processes of <strong>fluorescent-based separation</strong> split <strong>active/intact</strong> cells from <strong>damaged/non-active</strong> cells. As the main goal is the identification and quantification of live cells, these are often referred to as <strong>Active Fluorescent Units (AFU).</strong></p>
<h2></h2>
<p>&nbsp;</p>
<h2><span style="color: #873e90;"><em>Biose’s approach to become the reference in NGP manufacturing</em></span></h2>
<p>After more than 9 years as a <strong>leading CDMO for microbiome therapeutics</strong>, we aim to offer each market segment what it requires:</p>
<ul>
<li>For <strong>LBPs</strong> (<u>drug/medicinal products</u> with microorganisms as active ingredients), bacterial specificity and quantity are critical points. Overestimation of the bacterial concentration or potential uncertainty about the mix composition becomes a drug potency issue, alongside a potential safety issue. That is why, following international regulation (FDA guidance), manufacturing is tightly controlled using CFU-based techniques. The FDA, however, does propose implementing alternative methods (<em>see USP 1223</em>).</li>
<li>For <strong>NGPs</strong> (<u>dietary/food supplements</u> with microorganisms as active ingredients), the product is expected to be dominated by the intended microorganism(s), which is why ISO methodology can be acceptable as long as the QC systems effectively control for the expected purity and the method is adequately validated.</li>
</ul>
<h3></h3>
<p>&nbsp;</p>
<h3><em><span style="color: #873e90;"><strong>How we include AFU in our processes</strong></span></em></h3>
<p>AFU fits naturally across <strong>three manufacturing phases</strong>:</p>
<ol>
<li><strong>Upstream growth &amp; scale-up:</strong> providing rapid confirmation that concentration and population “fitness” are on track to continue with the <em>seed train</em> process.</li>
<li><strong>Downstream recovery &amp; concentration:</strong> bacterial collection and concentration are known to severely affect bacterial viability and integrity. Applying AFU-based enumeration between the independent steps is paramount when identifying potential bottlenecks in optimisation processes, improving overall bacterial recovery rates.</li>
<li><strong>Formulation &amp; finishing:</strong> using AFU enumeration to track how the active fraction survives the drying stage and evolves during storage allows for the improvement of shelf-life and process robustness.</li>
</ol>
<p>Operationally, the goal is <strong>efficiency with confidence</strong>. Clients can request AFU tracking between steps to confirm targets and verify final batch quality, but they can also ask for AFU application to multiple small samples to confirm a given batch is truly consistent.</p>
<p>At <strong>Biose</strong>, we have a strong commitment to providing the best quality standards while making use of the most innovative technology. This is why we have incorporated <strong>AFU bacterial characterisation</strong> for several strains among our services to ensure our clients have more accurate and faster feedback times, smaller sampling burdens, and an instantaneous with higher accuracy in-process control. We are now leveraging our deep expertise in microbiome products to optimise the QC processes of NGP production and scaling, so our clients can continue to innovate in the field, knowing their products are compliant with the latest regulatory requirements.</p>
<p>The post <a href="https://www.biose.com/bacterial-count-in-next-generation-probiotics-afu-technology/">Bacterial count in next-generation probiotics: AFU technology</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Microbiome at a Turning Point: This Year’s Breakthroughs and Next Year’s Big Bets</title>
		<link>https://www.biose.com/microbiome-at-a-turning-point-this-years-breakthroughs-and-next-years-big-bets/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Tue, 30 Dec 2025 14:50:56 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=30079</guid>

					<description><![CDATA[<p>As 2025 draws to a close, I would like to take a moment to reflect on the key events and trends shaping our industry — and how they position us [&#8230;]</p>
<p>The post <a href="https://www.biose.com/microbiome-at-a-turning-point-this-years-breakthroughs-and-next-years-big-bets/">Microbiome at a Turning Point: This Year’s Breakthroughs and Next Year’s Big Bets</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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										<content:encoded><![CDATA[<p>As 2025 draws to a close, I would like to take a moment to reflect on the key events and trends shaping our industry — and how they position us for the year ahead.</p>
<p>Despite a continued challenging economic environment across biotech, the past 12 months have brought meaningful progress for the microbiome field. We have seen encouraging developments in microbiome therapeutics, alongside impressive resilience from companies committed to addressing unmet medical needs for patients.</p>
<p>At the same time, new patterns are emerging with the rapid development of — and growing demand for — Next-Generation Probiotics.</p>
<p>Here at Biose Industrie, I am proud of how our teams navigated these dynamics while delivering strong results. In 2025, we onboarded more than 200 new client strains across our U.S. and EU facilities, produced 450 certified active-substance batches, and delivered 250 certified finished-product batches.</p>
<p>With early signs of renewed investor interest and new European public-funding initiatives building momentum into 2026, I am optimistic that our industry is preparing for a new wave of opportunity — not only next year, but well beyond.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><strong><em>Clinical and Regulatory Milestones</em></strong></span></h3>
<p>If there is one feature that has truly defined 2025 for the microbiome field, it is the strength of the Phase II and III therapeutic readouts.</p>
<p><strong><a href="https://www.maatpharma.com/january-8-2025-maat-pharma-announces-positive-topline-results-from-the-pivotal-phase-3-ares-study-evaluating-maat013-in-acute-graft-versus-host-disease/" target="_blank" rel="noopener">MaaT Pharma</a>’s Xervyteg® (MaaT013)</strong> demonstrated a three-fold increase in one-year survival among patients with GI-aGvHD in the pivotal ARES Phase III trial creating waves for the microbiome field and making headlines globally. These results supported submission to the EMA under an MAA — positioning Xervyteg® as potentially the first microbiota therapeutic in hemato-oncology.</p>
<p><a href="https://www.prnewswire.com/news-releases/siolta-therapeutics-reports-positive-phase-2-results-from-the-adored-study-302616190.html" target="_blank" rel="noopener"><strong>Siolta Therapeutics</strong></a> announced positive topline results from the Phase 2 ADORED study of STMC-103H, its lead oral microbial therapy. Infants completing one year of treatment showed a clinically meaningful reduction in the risk of developing atopic dermatitis and food allergy, including a <strong>77% reduction in physician-diagnosed food allergy</strong>, with consistent benefits across secondary endpoints.</p>
<p>In the metabolic space, <a href="https://bloomscience.com/" target="_blank" rel="noopener"><strong>Bloom Science</strong></a> reported that BL-001, an investigational oral therapy, achieved statistically significant placebo-adjusted weight loss at 28 days in a Phase 1 study.</p>
<p>We also saw <strong><a href="https://www.nature.com/articles/s41467-025-62752-4" target="_blank" rel="noopener">compelling long-term data published</a> </strong>in <em>Nature Communications</em>. In a cohort of adolescents originally enrolled in an FMT study eight years earlier, participants in the treatment arm were, on average, <strong>11 kg lighter</strong> than placebo recipients four years post-intervention.</p>
<p>Looking ahead, 2026 is poised to be a milestone year, with anticipated topline data from <strong><a href="https://www.vedantabio.com/" target="_blank" rel="noopener">Vedanta</a>’s Phase 3 RESTORATiVE-303 study</strong>, potential <strong>EMA marketing authorization for Xervyteg®</strong>, and possible <strong>FDA accelerated approval for <a href="https://ibtherapeutics.com/press-releases/ibt-changes-the-ibp-9414-pathway-for-approval-following-discussions-with-the-fda/" target="_blank" rel="noopener">Infant Bacterial Therapeutics</a>’ IBP-9414</strong> in the United States.</p>
<p>In addition, the <a href="https://www.biospace.com/press-releases/aob-pharma-receives-european-medicines-agency-ema-positive-decision-on-the-pediatric-investigation-plan-pip-supporting-future-development-of-b244-for-the-treatment-of-mild-to-moderate-atopic-dermatitis-in-children-adolescents-and-adults-in-the-european-union-eu" target="_blank" rel="noopener"><strong>EMA’s positive Pediatric Investigation Plan</strong></a> decision for <strong><a href="https://www.aobiome.com/" target="_blank" rel="noopener">AOB Pharma</a>’s B244</strong> in atopic dermatitis and pruritus enables AOBiome to move toward an initial MAA submission following completion of its pivotal and extension studies.</p>
<p>Finally, <a href="https://www.exeliombio.com/" target="_blank" rel="noopener"><strong>Exeliom Biosciences</strong></a> continues advancing multiple Phase 2 programs evaluating a <em>Faecalibacterium prausnitzii</em>-derived LBP to prevent post-surgical recurrence in Crohn’s disease and as an adjuvant across several oncology indications with data expected in early 2027.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>Promising Financial Indicators</strong></em></span></h3>
<p>2025 also brought encouraging financial signals for the microbiome and next-generation probiotics sector:</p>
<p><strong><a href="https://mrmhealth.com/docs/MRM%20Health%20EUR55%20Mio%20Series%20B%20raise.pdf" target="_blank" rel="noopener">MRM Health</a></strong> successfully closed a €55M Series B round — a landmark raise that drew widespread attention across the European biotech ecosystem. <strong><a href="https://www.sniprbiome.com/" target="_blank" rel="noopener">SNIPR Biome</a></strong> likewise completed its Series B at $35M, bringing its total funding to more than $90M to continue advancing its pipeline.</p>
<p>The acquisition of <a href="https://www.theakkermansiacompany.com/" target="_blank" rel="noopener"><strong>The Akkermansia Company</strong></a> by Danone in July marked a significant inflection point for the next-generation probiotics market, underscoring growing strategic interest from major consumer health players.</p>
<p>Beyond these transactions, we observed several early-stage financings as well as two announcements with important implications for the years ahead:</p>
<ul>
<li><strong><a href="https://www.novonordisk.com/" target="_blank" rel="noopener">Novo Nordisk</a> and <a href="https://www.novonesis.com/en" target="_blank" rel="noopener">Novonesis </a></strong>entered into a partnership to explore the role of the gut microbiome in metabolic health — with the dual aim of informing product development and identifying predictive biomarkers for obesity prevention.</li>
<li><a href="https://wellcomeleap.org/" target="_blank" rel="noopener"><strong>Wellcome Leap</strong></a> launched the <a href="https://wellcomeleap.org/form/" target="_blank" rel="noopener"><strong><em>FORM (Foundations of a Resilient Microbiome)</em> program</strong></a> — a $50M initiative designed to investigate the causal link between early-life microbiome dysfunction and neurodevelopmental conditions such as autism.</li>
</ul>
<p>Together, these developments reinforce gr owing investor confidence and highlight the strategic relevance of microbiome science across pharma and consumer health.</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>T</strong></em><em><strong>he EU Biotech Sector</strong></em></span></h3>
<p>As the CEO of a company with facilities in France and the US and Treasurer of the European Microbiome Innovation for Health, I have been well-positioned over the past years to monitor both the EU and US markets closely.</p>
<p>The EU has traditionally controlled the biotech market through tighter regulations and reduced market exclusivity periods, a strategy that inadvertently signalled a ‘hostile’ environment for R&amp;D and drove significant capital migration to the United States. This ‘production drain’ was starkly validated by the recent <strong><a href="https://commission.europa.eu/topics/competitiveness/draghi-report_en" target="_blank" rel="noopener">Draghi report</a></strong>, which identified the chronic investment gap as a primary threat to European stability within the biotech industry.</p>
<p>However, it is great to see important steps being taken that will greatly increase the EU’s competitive position moving in to 2026 with the announcement of The <a href="https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en" target="_blank" rel="noopener"><strong>Biotech Act</strong></a> and the <a href="https://www.eib.org/en/press/news/european-commission-and-eib-group-announce-new-initiative-to-mobilise-eur10-billion-investment-for-europe-s-biotech-sector" target="_blank" rel="noopener"><strong>€10 billion BioTechEU initiative</strong></a>. By introducing regulatory sandboxes, simplifying clinical trials, and creating a massive capital injection, the European Commission aims to strengthen the EU biotech sector with the objective to restore a regulatory and industrial environment capable of sustaining innovation within Europe.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>The Consolidation of Live Biotherapeutics Products &amp; Next Generation Probiotics</strong></em></span></h3>
<p>To properly understand the current microbiome landscape, it’s essential to understand how it now spans two converging and increasingly interconnected sectors:</p>
<p><strong>Live Biotherapeutic Products (LBPs)</strong> are fully regulated biological medicines developed under stringent GMP conditions and supported by advanced CMC packages, and multi-phase clinical trials.</p>
<p><strong>Next-Generation Probiotics (NGPs)</strong> by contrast, are positioned within the Consumer-health space but are increasingly underpinned by strain-specific clinical data, multi-omics characterisation, and precision formulation strategies. Companies such as <strong><a href="https://pendulumlife.com/" target="_blank" rel="noopener">Pendulum</a></strong>, <strong><a href="https://www.designsforhealth.com/" target="_blank" rel="noopener">Design for Health</a></strong>, <strong><a href="https://verbbiotics.com/" target="_blank" rel="noopener">Verb Biotics</a></strong>, and <strong><a href="https://clostrabio.com/index.html" target="_blank" rel="noopener">Clostra Bio</a></strong> are generating robust real-world datasets feeding therapeutic discovery.</p>
<p>Increasingly, microbiome companies are considering a dual strategy, leveraging their expertise in LBPs to launch NGPs. This approach allows companies to generate early revenue and gather solid scientific evidence while navigating the lengthy pathway for biological drugs.</p>
<p>Despite distinct regulatory frameworks, both LBPs and NGPs rely on shared biology and industrial foundations such as fermentation and formulation technologies, analytical methods, manufacturing infrastructure, supply-chain management, and downstream quality and data systems. This convergence is giving rise to a unified industrial ecosystem, and ample market opportunities for Biose. making NGPs a primary focus area for our company’s strategy moving forward.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>It’s all about the Science</strong></em></span></h3>
<p>Albeit I am writing this letter as Biose’s CEO, <strong>I am a scientist at heart </strong>and especially excited to see recent advances in both basic and population-level research.</p>
<p>What were once viewed largely as associative “gut–organ” links are now increasingly supported by mechanistic evidence, moving the field from correlation toward causality.</p>
<p>Studies published this year have shown that specific gut-derived metabolites do not merely circulate through the body, but actively influence immune function in peripheral tissues such as the skin and lungs, effectively acting as systemic signalling molecules.</p>
<p>At the same time, researchers are beginning to characterise microbial communities in biological sites that were long considered sterile or biologically marginal. Emerging data indicate that low-biomass environments — including intratumoral niches and the ocular surface harbor distinct microbial signatures capable of modulating disease progression and influencing responses to existing therapies.</p>
<p>As research increasingly moves beyond the gut, <strong>women’s health</strong> has emerged as one of the most compelling areas where microbiome science is now delivering robust, mechanistic insights.</p>
<p>Over the past years, several academic groups and industrials— including work conducted by <strong><a href="https://seed.com/" target="_blank" rel="noopener">Seed Health</a></strong>, <strong><a href="https://freyabiosciences.com/" target="_blank" rel="noopener">Freya Biosciences</a></strong>, <strong><a href="https://www.biocodex.com/en/" target="_blank" rel="noopener">Biocodex</a></strong>, and teams at <strong><a href="https://www.massgeneral.org/" target="_blank" rel="noopener">Massachusetts General Hospital</a></strong> — have significantly contributed to elevating vaginal microbiome research to the level of global health priorities, with initiatives that have reached major institutional stakeholders such as the Gates Foundation.</p>
<p><a href="https://www.nature.com/articles/s41522-025-00788-6" target="_blank" rel="noopener"><strong>Recent publications</strong></a> have moved the field beyond descriptive abundance profiling, demonstrating how <strong><em>Lactobacillus crispatus</em>–dominated ecosystems form structured, protective biofilms</strong> that actively reinforce epithelial integrity and limit pathogen invasion. These findings provide a mechanistic framework explaining why <em>L. crispatus</em>–rich microbiota is consistently associated not only with protection against bacterial vaginosis, but also with improved reproductive and gestational outcomes.</p>
<p>In parallel, growing clinical and translational evidence continues to strengthen the rationale for strain-specific approaches in women’s health. Recent peer-reviewed studies published in 2024–2025 have further documented the functional properties of <em>Lacticaseibacillus rhamnosus</em> Lcr35, including its capacity to modulate host–microbe interactions across multiple indications, from mucosal protection to systemic metabolic and inflammatory pathways, moving away from generic probiotic concepts toward <strong>well-characterized, clinically validated strains</strong>.</p>
<h3></h3>
<p>&nbsp;</p>
<h3><span style="color: #873e90;"><em><strong>Co</strong></em><em><strong>nclusion</strong></em></span></h3>
<p>The microbiome field is coming out of a transition period, being defined by in-human data, industrial maturity, and clear regulatory pathways. With some important milestones expected and signs of a recovering financing landscape I remain bullish entering 2026.</p>
<p>At Biose we look forward to another year of continuing to support leading microbiome companies around the world with their mission of developing the next generation of microbiome products for patients with unmet medical needs.</p>
<p>Supporting our clients with this mission is the very foundation of our business and as such, I’d like to close this year’s wrap-up with the words of Adam Wilkinson, Vice President of Pre-Clinical Development at Microbiotica:</p>
<blockquote><p><em>“Working in partnership with the Biose team, we are delighted to have successfully navigated the challenges of process development and scale-up of two LBPs in parallel. Manufacturing of biologics can be challenging at the best of times, but the development of multiple processes to be scaled up to cGMP standard poses significant challenges, and seamless open collaboration between our project teams has been essential to success”</em></p></blockquote>
<p>&nbsp;</p>
<p>Wishing everyone a very Happy New Year filled with joy and success.</p>
<p>Yours Sincerely,</p>
<p>&nbsp;</p>
<p><img loading="lazy" decoding="async" class="alignnone wp-image-29050" src="https://www.biose.com/wp-content/uploads/2024/12/an-300x300.jpeg" alt="" width="126" height="126" srcset="https://www.biose.com/wp-content/uploads/2024/12/an-300x300.jpeg 300w, https://www.biose.com/wp-content/uploads/2024/12/an-150x150.jpeg 150w, https://www.biose.com/wp-content/uploads/2024/12/an-96x96.jpeg 96w, https://www.biose.com/wp-content/uploads/2024/12/an.jpeg 430w" sizes="auto, (max-width: 126px) 100vw, 126px" /></p>
<h3><em>Adrien Nivoliez</em></h3>
<p>Chief Executive Officer, Biose Industrie</p>
<p>The post <a href="https://www.biose.com/microbiome-at-a-turning-point-this-years-breakthroughs-and-next-years-big-bets/">Microbiome at a Turning Point: This Year’s Breakthroughs and Next Year’s Big Bets</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>A Microbiome Odyssey Across Asia in 10 days</title>
		<link>https://www.biose.com/a-microbiome-odyssey-across-asia-in-10-days/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Thu, 05 Jun 2025 06:35:51 +0000</pubDate>
				<category><![CDATA[Non classé]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=29471</guid>

					<description><![CDATA[<p>by Richard Ellis As all good adventures begin, mine started with… a delay. Toulouse to CDG went from “on time” to “technical difficulties” faster than failing to connect to the [&#8230;]</p>
<p>The post <a href="https://www.biose.com/a-microbiome-odyssey-across-asia-in-10-days/">A Microbiome Odyssey Across Asia in 10 days</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h3><span style="color: #873e90"><strong>by Richard Ellis</strong></span></h3>
<p>As all good adventures begin, mine started with… a delay. Toulouse to CDG went from “on time” to “technical difficulties” faster than failing to connect to the flight wifi, which meant I missed my original connection to Singapore. Grrh.</p>
<p>Thankfully, years of airline travel (and platinum status with Air France) have taught me to anticipate chaos. I phoned in a lifeline mid-delay and secured a seat on a later flight via Hong Kong. Crisis managed &#8211; sort of. I landed in Singapore fashionably late, just in time for my morning presentation at the <strong>Microbiome Business Collaboration</strong> event by Global engage. Nothing quite like going from jet bridge to spotlight with nothing but a power nap and a prayer.</p>
<p>Now, I’m not a natural-born for the conference as a non-scientist I have an imposter syndrome thing going on. Put me in a partner meeting or a business dinner and I’m at home. Put me on stage, sleep-deprived and sweating through Singapore’s 200% humidity index, and I’m&#8230; less at home. But with a deep breath and a mild existential crisis, I made it through. My talk on <strong>LBP &amp; NGP development </strong>(featuring highlights on strain CMC development and production, and lessons from over 30 clinical and commercial projects) was well-received – or at least, no everybody got up and left mid-sentence.</p>
<p>The rest of the event was a rewarding blend of science, networking, and a solid reminder that the microbiome world never sleeps – even if I desperately needed to.</p>
<p>Some presentations that I found particularly insightful from this whirlwind of a trip include:</p>
<p><strong>Bridgette Wilson, PhD – Dietary Impact on Gut Microbiome in Health and Gastrointestinal Disorders</strong></p>
<p>Focusing on gastrointestinal disorders like IBS, Dr. Wilson’s presentation explored how diet shapes the gut microbiome. She explained that while a low FODMAP diet shows efficacy in managing IBS symptoms, it also depletes beneficial gut bacteria such as <em>Bfidobacterium</em> – leading to concerns about its long-term use. To address this, Dr Wilson explained different approaches including probiotic and prebiotic supplementation. Wilson showed that in one trial supplementation of a multi-strain probiotic increased numbers of <em>Bifidobacterium</em> species in patients on low FODMAP compared to the control &#8211; a positive result. However, prebiotic supplementation with B-GOS, while improving symptoms, did not prevent the loss. Wilson closed by emphasising the need for personalised dietary solutions for IBS and cautioned against long term low FODMAP use.</p>
<p><strong>Prof. Maurice van Steensel – The Case for Selective Microbiome Control</strong></p>
<p>Opening by describing the importance of the skin microbiome in maintaining skin health, Prof Steensel presented the case for selective anti-bacterials in managing acne and body odour. Steensel explained that existing treatments for skin dysbiosis wipe out all bacterial populations, not distinguishing between the helpful strains such as <em>S. epidermis</em> and the pro-inflammatory ones like <em>C. acnes.</em> To overcome this, Steensel’s company ArrowBiome are developing targeted solutions based on lysins. Steensel introduced SmartArrow™, a precision payload delivery system, and ArcherZyme™, an engineered lysin, designed to clear harmful bacteria without irritating the skin. Data presented indicated SmartArrow™ could achieve bacterial clearance at significantly lower concentrations than conventional products.</p>
<p><strong>Cherry Li – Large-scale Skin Metagenomics Reveals Extensive Prevalence, Coordination, and Functional Adaptation of Skin Microbiome Dermotypes Across Body Sites</strong></p>
<p>Presenting data from one of the largest studies to date on the skin microbiome, Cherry Li revealed that analysis of over 3,500 metagenomes from 200 healthy individuals across 18 body sites identified 17 distinct “dermotypes” – unique microbial community types. Interestingly, these dermotypes were not restricted to specific sites but were consistently observed across different regions of the body. Li highlighted that certain dermotypes were linked to increased skin sensitivity and itch, even in individuals without diagnosed skin conditions. Li closed by highlighting emphasising how these findings could lay the groundwork for personalised dermatological therapies based on dermotype, moving beyond the current one-size-fits-all approach.</p>
<p><strong>Dr. Mrinmoy Mazumder – Harnessing Beneficial Plant-Associated Microbiomes to Enhance Crop Yield, Quality, and Climate Resilience</strong></p>
<p>Dr. Mazumder presented his team’s work on designing microbial consortia to boost crop yield, quality, and climate resilience. Using advanced culturomics and genome modelling, his group developed bacterial consortia that enhanced traits such as drought tolerance, sulphur uptake, and pest resistance in Arabidopsis and Kai-lan. He also highlighted how root-derived volatile organic compounds (VOCs) can stimulate beneficial soil biofilms from a distance, expanding a plant’s microbial sphere of influence and promoting growth.</p>
<p>Jet lag in Asia is its own special kind of torture. When your body thinks it&#8217;s 2am and the conference coffee is doing nothing, all bets are off. That said, I made the most of my Saturday in Singapore: the National Museum (blessedly air-conditioned), followed by a bold but ill-advised venture through Chinatown and Little India. After being flambéed by the equatorial sun, I beat a strategic retreat to the hotel pool.</p>
<p>Sunday morning: off to Korea! It’s the Asian country I visit most, yet it never ceases to amaze me. The food is a masterclass in fermentation, the people combine warmth with relentless drive, and there&#8217;s a palpable scientific energy – especially when it comes to microbiology and the microbiome. Not surprising then that Korea has been home to over a dozen clinical LBP lines we&#8217;ve worked on at Biose in the past seven years.</p>
<p>This Korean leg of the journey was particularly fruitful: promising discussions with long-standing partners, new collaborations emerging, and some genuinely exciting developments I look forward to sharing soon.</p>
<p>From the heat of Singapore to the buzz of Seoul, this trip reminded me why we do what we do – and how far microbiome science has come, from petri dish to patient. And maybe, just maybe, I’m starting to get used to public speaking. (But let’s not get carried away.)</p>
<p>The post <a href="https://www.biose.com/a-microbiome-odyssey-across-asia-in-10-days/">A Microbiome Odyssey Across Asia in 10 days</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Next Generation Probiotics (NGPs) – The Next Era of Probiotics?</title>
		<link>https://www.biose.com/next-generation-probiotics-ngps-the-next-era-of-probiotics/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Tue, 15 Apr 2025 14:15:42 +0000</pubDate>
				<category><![CDATA[Non classé]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=29385</guid>

					<description><![CDATA[<p>What are NGPs? The International Scientific Association for Prebiotics and Probiotics defines probiotics as “Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.”1 Traditionally [&#8230;]</p>
<p>The post <a href="https://www.biose.com/next-generation-probiotics-ngps-the-next-era-of-probiotics/">Next Generation Probiotics (NGPs) – The Next Era of Probiotics?</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>What are NGPs?</strong></p>
<p>The International Scientific Association for Prebiotics and Probiotics defines probiotics as “Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.”<sup>1</sup></p>
<p>Traditionally probiotic products have comprised a narrow spectrum of micro-organisms, mostly containing strains from the <em>bifidobacterium</em> or <em>lactobacillus</em> genera isolated from fermented foods.</p>
<p>Recently however, scientists have turned their attention to new species that could confer benefit to the host, with the novel organisms being referred to as “next generation probiotics” or NGPs. Species within this category include <em>Eubacterium hallii, Faecalibacterium prausnitzii, Roseburia spp., Akkermansia muciniphila, </em>and<em> Bacteroides fragilis </em>or they can be innovative engineered strains designed to perform a specific function<em>. </em>These strains are often sourced from the gut and are anaerobic by nature.</p>
<p><strong>How do NGPs differ from existing probiotics?</strong></p>
<p>Contrasted with traditional probiotics, NGP species have been identified for their specific health benefits and function. These functions include short-chain fatty acid production, intestinal barrier regulation and immune system modulation.</p>
<p>Some NGP spp. have been associated with disease states. For instance, in 2008 the Sokol lab documented a depletion of <em>Faecalibacterium prausnitzii </em>in the gut microbiome of Crohn’s disease patients, with its lower abundance being linked to a higher risk of clinical flare.<sup>2</sup></p>
<p><strong>The NGP Landscape</strong></p>
<p>The newness of the NGP market makes it a very exciting area of microbiome research, forecasted to more than double in size from 231 million USD in 2025 to 486 million USD by 2032.<sup>3</sup> Companies are utilizing the unique properties of NGPs to provide consumers and patients with novel health benefits.</p>
<p><strong>Pendulum Therapeutics</strong></p>
<p>Based in San Francisco and founded in 2012, Pendulum Therapeutics has raised $111M to date.<sup>4</sup> Pendulum therapeutics offers a variety of OTC probiotics, all containing <em>A. muciniphila</em> as well as other NGP strains. Naturally occurring in the gut,<em> A. muciniphila</em> has been associated with improved metabolic health, including a reduction in obesity risk and an increase in heart health.<sup>5</sup></p>
<p>In March 2024, they launched their GLP-1 Probiotic, consisting of the 2 NGP strains <em>A. muciniphila</em> and <em>Clostridium butyricum.<sup>6</sup></em> Pendulum reference various preclinical studies to support their claim that their GLP-1 Probiotic can upregulate GLP-1 secretion in the host. One such study found that a metabolite secreted by <em>A. muciniphila</em> increased GLP-1 secretion in mice. In unpublished company data, Pendulum also reports a dose-dependent increase of GLP-1 by <em>Clostridium butyricum</em> in a cell-based assay. The company is currently testing their GLP-1 probiotic in a clinical trial with completion expected in 2025.<sup>7 </sup>The company also has active trials examining the impact of their NGPs on bipolar disorder, and bone health.</p>
<p><strong>The Akkermansia Company </strong></p>
<p>Also leveraging the health benefits of <em>A. muciniphila </em>is the Akkermansia Company in Belgium. Founded in 2004, the company was founded on the discovery of <em>A municinphila</em> by Willem M. de Vos’ laboratory of Wageningen University and the Patrice Cani’s research from UCLouvain. To date it has raised $21.9M in funding.<sup>8</sup> Notably, The Akkermansia Company utilise a proprietary pasteurised form of <em>A. muciniphila</em>, Akkermansia MucT. Their product “Healthy Weight” has been available in Europe since 2021 and launched into the US in June 2024.<sup>9</sup></p>
<p>In 2019, a randomised double-blind study conducted by The Akkermansia Company, the Microbes4U® study, found pasteurized <em>A. muciniphila</em> improved insulin sensitivity, reduced insulinemia and reduced plasma total cholesterol compared to the placebo in human subjects – interestingly, only the pasteurised form led to reduced cholesterol versus the live form.<sup>10</sup> Bolstering these findings, a paper in Nature identified that pasteurised <em>Akkermansia</em> better strengthened intestinal integrity and lipid metabolism than the live form in a tissue model. <sup>11</sup></p>
<p><strong>ClostraBio</strong></p>
<p>A spin-out from the University of Chicago, ClostraBio are developing an NGP for targeted delivery of butyrate to promote gut health and intestinal barrier integrity.   Butyrate is critical to gut homeostasis, as it serves as the primary carbon source for colonocytes and promotes barrier integrity by upregulating tight junction proteins<sup>12</sup> and increasing mucin production<sup>13</sup>.   However, decreased butyrate levels have been observed in individuals afflicted with numerous chronic diseases<sup>12,14</sup> as well as those consuming a Western diet<sup>15,16</sup>.   ClostraBio’s CLB101 is an NGP that has been shown to produce high levels of butyrate from fermentation of prebiotics as well as from the lactate and acetate excreted by common gut commensals like <i>Bifidobacteria</i><sup>17</sup>.  Manufacture of CLB101 has been successfully scaled to commercial capacity with a planned product launch in 2025<sup>18</sup>.</p>
<p><strong>Florey Biosciences</strong></p>
<p>Spun out from Cubillos-Ruiz’s research in the MIT and Wyss Institute lab of James Collins, Ph.D., Florey Biosciences are developing genetically engineered probiotics to improve human health. Their lead product FLR-101, consists of a food-grade yeast strain which produces an enzyme to degrade beta-lactam antibiotics – which represents approximately 50% of antibiotics used. Antibiotic consumption significantly disrupts the fragile balance of the gut microbiome, an inconvenient side-effect of a highly useful drug class. Florey aim to eliminate this side-effect by shielding the gut microbiome with the beta-lactam degrading effects of FLR-101. As the yeast is localised to the gut, the antibiotics can still act on infection elsewhere in the body.<sup>19</sup> Currently, Florey are pursuing a medical food designation for their probiotic product.</p>
<p>In a 2022 proof of concept paper, the team demonstrated in vivo that an engineered strain of Lactococcus lactis could effectively degrade beta-lactam in the gut of mice, without impacting the serum levels of the antibiotic. The paper notes that the beta-lactamase gene does not confer antibiotic resistance to the host strain and is not susceptible to horizontal gene transfer.<sup>20</sup></p>
<p><strong>Looking to develop an NGP?</strong></p>
<p>In addition to our world-leading LBP manufacturing solutions, Biose Industrie have fully anaerobically sealed industrial production lines for NGPs with over 600 different strains being manufactured for the different clients around the world!</p>
<p>If you are interested in manufacturing a NGP product, <a href="https://www.biose.com/contact-us/">get in touch here</a>.</p>
<p><img loading="lazy" decoding="async" class="alignnone size-medium wp-image-29387" src="https://www.biose.com/wp-content/uploads/2025/04/pic-1-300x160.png" alt="" width="300" height="160" srcset="https://www.biose.com/wp-content/uploads/2025/04/pic-1-300x160.png 300w, https://www.biose.com/wp-content/uploads/2025/04/pic-1.png 501w" sizes="auto, (max-width: 300px) 100vw, 300px" /></p>
<p><strong>Sources:</strong></p>
<ol>
<li><a href="https://isappscience.org/for-scientists/resources/probiotics/">https://isappscience.org/for-scientists/resources/probiotics/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/18936492/">https://pubmed.ncbi.nlm.nih.gov/18936492/</a></li>
<li><a href="https://www.coherentmarketinsights.com/market-insight/next-generation-probiotics-market-5468#:~:text=Next%20Generation%20Probiotics%20Market%20is,technological%20robustness%2C%20and%20regulatory%20framework">https://www.coherentmarketinsights.com/market-insight/next-generation-probiotics-market-5468#:~:text=Next%20Generation%20Probiotics%20Market%20is,technological%20robustness%2C%20and%20regulatory%20framework</a>.</li>
<li><a href="https://tracxn.com/d/companies/pendulum/__luVW54RO5auUerhcc7Q13foJzCh3cnrhYFPDQPxijj4">https://tracxn.com/d/companies/pendulum/__luVW54RO5auUerhcc7Q13foJzCh3cnrhYFPDQPxijj4</a></li>
<li><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC8726741/">https://pmc.ncbi.nlm.nih.gov/articles/PMC8726741/</a></li>
<li><a href="https://www.prnewswire.com/news-releases/pendulum-therapeutics-introduces-glp-1-probiotic-302087492.html">https://www.prnewswire.com/news-releases/pendulum-therapeutics-introduces-glp-1-probiotic-302087492.html</a></li>
<li><a href="https://pendulumlife.com/pages/research-clinical-trials">https://pendulumlife.com/pages/research-clinical-trials</a></li>
<li><a href="https://tracxn.com/d/companies/the-akkermansia-company/__4YBN0NiDL_m1dVG3gqB8tqCu-XPJDph8X-niTLucL6A/funding-and-investors">https://tracxn.com/d/companies/the-akkermansia-company/__4YBN0NiDL_m1dVG3gqB8tqCu-XPJDph8X-niTLucL6A/funding-and-investors</a></li>
<li><a href="https://www.nutraingredients-usa.com/Article/2025/03/06/the-akkermansia-co-on-weight-management-with-akkermansia-muciniphila/#:~:text=The%20Akkermansia%20Company%20launched%20into,decoded%20by%20the%20company's%20founders">https://www.nutraingredients-usa.com/Article/2025/03/06/the-akkermansia-co-on-weight-management-with-akkermansia-muciniphila/#:~:text=The%20Akkermansia%20Company%20launched%20into,decoded%20by%20the%20company&#8217;s%20founders</a>.</li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/31263284/">https://pubmed.ncbi.nlm.nih.gov/31263284/</a></li>
<li><a href="https://www.nature.com/articles/s41598-021-95738-5">https://www.nature.com/articles/s41598-021-95738-5</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/36502573/">https://pubmed.ncbi.nlm.nih.gov/36502573/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/34819742/">https://pubmed.ncbi.nlm.nih.gov/34819742/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/30643289/">https://pubmed.ncbi.nlm.nih.gov/30643289/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/26742586/">https://pubmed.ncbi.nlm.nih.gov/26742586/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/36177011/">https://pubmed.ncbi.nlm.nih.gov/36177011/</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/16672507/">https://pubmed.ncbi.nlm.nih.gov/16672507/</a></li>
<li><a href="https://clostrabio.com/about.html">https://clostrabio.com/about.html</a></li>
<li><a href="https://www.fiercebiotech.com/research/florey-biosciences-spins-out-harvards-wyss-institute-cook-proven-probiotic-medical-foods">https://www.fiercebiotech.com/research/florey-biosciences-spins-out-harvards-wyss-institute-cook-proven-probiotic-medical-foods</a></li>
<li><a href="https://pubmed.ncbi.nlm.nih.gov/35411114/">https://pubmed.ncbi.nlm.nih.gov/35411114/</a></li>
</ol>
<p>The post <a href="https://www.biose.com/next-generation-probiotics-ngps-the-next-era-of-probiotics/">Next Generation Probiotics (NGPs) – The Next Era of Probiotics?</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Microbiome Wrapped 2024 – A Year in Review &#038; What’s Next</title>
		<link>https://www.biose.com/29045-2/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Mon, 30 Dec 2024 10:09:08 +0000</pubDate>
				<category><![CDATA[Non classé]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=29045</guid>

					<description><![CDATA[<p>By Adrien Nivoliez Chief Executive Officer, Biose Industrie &#160; As the year draws to a close today, I’d like to reflect on the microbiome landscape in 2024: Unfortunately, conditions remained [&#8230;]</p>
<p>The post <a href="https://www.biose.com/29045-2/">Microbiome Wrapped 2024 – A Year in Review &amp; What’s Next</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
]]></description>
										<content:encoded><![CDATA[<blockquote>
<h3><em>By Adrien Nivoliez</em><em><img loading="lazy" decoding="async" class="wp-image-29050 alignleft" src="https://www.biose.com/wp-content/uploads/2024/12/an-300x300.jpeg" alt="" width="102" height="102" srcset="https://www.biose.com/wp-content/uploads/2024/12/an-300x300.jpeg 300w, https://www.biose.com/wp-content/uploads/2024/12/an-150x150.jpeg 150w, https://www.biose.com/wp-content/uploads/2024/12/an-96x96.jpeg 96w, https://www.biose.com/wp-content/uploads/2024/12/an.jpeg 430w" sizes="auto, (max-width: 102px) 100vw, 102px" /></em></h3>
<p>Chief Executive Officer, Biose Industrie</p>
<p>&nbsp;</p></blockquote>
<p>As the year draws to a close today, I’d like to reflect on the <strong>microbiome landscape</strong> in 2024:</p>
<p>Unfortunately, conditions remained <strong>particularly challenging</strong> for pre-revenue biotechs raising funds for <strong>microbiome-based therapeutic programs</strong>, and this was felt by the market with several programs discontinued, a handful of biotechs closing their doors, and even some <strong>microbiome industry-specific</strong> service providers shutting down.</p>
<p>Despite this, 2024 was an <strong>extremely significant and historical year</strong> for the field as we had <strong>indisputable scientific evidence that defined Live Biotherapeutics work!</strong></p>
<p><strong><a href="https://ibtherapeutics.com/">Infant Bacterial Therapeutics</a>’ Phase 3 readout</strong> demonstrated a <strong>27% reduction in all-cause mortality</strong> for infants with necrotizing enterocolitis. Beyond its significance for the market as potentially the <strong>first FDA and EMA-approved single-strain LBP</strong>, <strong>Infant Bacterial Therapeutics’ product saves babies&#8217; lives!</strong></p>
<p>This, for me, is far more important than any <strong>short-term hurdles</strong> our industry is currently facing and is what should also be more important for everyone else too. At the end of the day, it is now a <strong>fact that defined LBPs have the potential to save lives</strong>, and IBT’s <strong>Phase 3 study comprising 2,153 premature infants</strong> is testimony to just that.</p>
<p>Of course, there were other <strong>important milestones</strong> reached by a number of companies progressing <strong>microbiome science in and out of the clinic</strong>, some <strong>sizeable fundraises</strong>, new spin-outs, and <strong>important clinical data</strong>. Furthermore, it was great to see some very <strong>sizeable public investment commitments</strong>.</p>
<p>Below, I share some highlights throughout <strong>2024</strong> and some of the things that I am particularly excited about coming up in <strong>2025</strong>:</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>Fundraising in the Microbiome</em></strong></span></h3>
<p>Despite 2024 being a difficult year for <strong>early-stage biotechs</strong>, there were some <strong>significant investments across the microbiome field</strong>, such as:</p>
<ul>
<li><strong>$12M</strong> raised by <strong>Kanvas Biosciences</strong>, <strong>Siolta Therapeutics</strong>, and <strong>Z-Biotics</strong>.</li>
<li>A <strong>$10.4M strategic grant</strong> from the <strong>Bill &amp; Melinda Gates Foundation</strong> into <strong>Freya Biosciences</strong>.</li>
<li><strong>£27M</strong> raised by <strong>EnteroBiotix</strong>.</li>
<li>Additional funding rounds: <strong>$9M for Holobiome</strong>, <strong>$4.2M for Ancilia Biosciences</strong>, and <strong>$2M for Neobe Therapeutics</strong>.</li>
<li><strong>€20M</strong> funding for <strong>SNIPR Biome</strong> from the <strong>European Innovation Council</strong>.</li>
</ul>
<p>On the <strong>public funding side</strong>, the <strong>Dutch government</strong> allocated <strong>€200 million</strong> specifically for <strong>microbiome research</strong> through the establishment of the <a href="https://holomicrobioom.nl/en/home-en/"><strong>Holomicrobiome Institute</strong></a>.</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>M&amp;A and Partnerships in 2024</em></strong></span></h3>
<p>2024 also witnessed <strong>strategic mergers and acquisitions</strong>:</p>
<ul>
<li>The formation of the <a href="https://cmbio.io/"><strong>Cmbio brand</strong></a> through the merger of <strong>Clinical Microbiomics</strong>, <strong>CosmosID</strong>, <strong>MS-Omics</strong>, <strong>DNASense</strong>, and <strong>Microba’s Research Services Unit</strong>.</li>
<li><strong>Probi’s acquisition by Symrise</strong>.</li>
<li><strong>Lactobio’s acquisition by L’Oréal</strong>.</li>
</ul>
<p>One standout partnership was between the <strong>Novo Nordisk Foundation</strong>, <strong>Wellcome Trust</strong>, and the <strong>Bill &amp; Melinda Gates Foundation</strong>, with a <strong>$300M commitment</strong> aimed at advancing global health equity. Notably, the <strong>microbiome</strong> was highlighted as a <strong>key area of focus</strong> for addressing <strong>nutritional and immunological health challenges</strong>.</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>Clinical read-outs </em></strong></span></h3>
<p>As already mentioned, <strong>Infant Bacterial Therapeutics (IBT)</strong> reported <strong>positive Phase 3 results</strong> for their candidate targeting <strong>infant necrotizing enterocolitis</strong>, showing a <strong>27% reduction in all-cause mortality</strong>. If approved, this would represent the <strong>first FDA approval of a single-strain Live Biotherapeutic Product (LBP)</strong>.</p>
<ul>
<li><a href="https://www.maatpharma.com/"><strong>Maat Pharma</strong></a> presented <strong>positive 18-month data</strong> for <strong>MaaT013</strong>, showing a <strong>clear overall survival advantage</strong> in <strong>acute Graft-versus-Host Disease (aGvHD)</strong> for 140 patients at the 2024 Annual congress of the European Society for Bone and Marrow Transplantation. As we enter 2025, I am particular excited for MaaT Pharma’s official phase 3 Ares read-out!</li>
<li><a href="https://mrmhealth.com/"><strong>MRM Health</strong></a> announced <strong>positive Phase 2a results</strong> for <strong>pouchitis and ulcerative colitis, </strong>significant indications with substantial market potential.</li>
<li><strong>EnteroBiotix</strong> reported <strong>successful Phase 1b results</strong> for their program in <strong>liver cirrhosis</strong>.</li>
<li><strong>Seres Therapeutics</strong> shared <strong>positive Phase 1b safety and clinical results</strong>.</li>
</ul>
<p>Additionally, during the <strong>Microbes in Women’s Health Congress</strong> in <strong>Copenhagen (April 2024)</strong>, I had the opportunity to present alongside leading <strong>KOLs Caroline Mitchell</strong> and <strong>Jacques Ravel</strong> on the development of two <strong>multi-strain LBPs</strong>, <strong>LC106</strong> and <strong>LC115</strong>, targeting <strong>bacterial vaginosis (BV)</strong>. These drug products, each containing multiple <em>Lactobacillus crispatus</em> strains, were designed based on insights from stable vaginal microbiomes.</p>
<p>2024 also saw two <strong>landmark Nature publications</strong>:</p>
<ul>
<li><strong><a href="https://eligo.bio/">Eligo Bioscience</a>’s</strong> study on <strong>genetically modifying bacteria in the gut with nearly 100% efficiency</strong>.</li>
<li><strong>Immunobiome’s</strong> research on <strong>microbiome-based cancer therapies</strong>, focusing on <strong>iron deprivation in the tumor microenvironment</strong>.</li>
</ul>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>Some other promising 2025 clinical read-outs I am excited about include:</em></strong></span></h3>
<ul>
<li><strong>Genome &amp; Company’s</strong> Phase 2 trials for GEN001, targeting stomach cancer and biliary tract cancer</li>
<li><strong>Microbiotica’s</strong> Phase 1b trial for MB097, targeting advanced melanoma in patients who have failed to respond to immunotherapies</li>
<li><strong>Biomica’s</strong> Phase 1 trial for BMC128, focused on patients with non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC) who previously progressed on immunotherapy</li>
<li><strong>CJ Biosciences’</strong> Phase 1/2 trial for CJRB-101, investigating its efficacy in solid tumours including NSCLC and melanoma</li>
<li><strong>Everimmune’s</strong> Phase 1/2 trial for EV997, evaluating safety and preliminary efficacy in combination with immune checkpoint inhibitors for solid tumour</li>
<li><a href="https://www.exeliombio.com/" target="_blank" rel="noopener" data-saferedirecturl="https://www.google.com/url?q=https://www.exeliombio.com/&amp;source=gmail&amp;ust=1738164383784000&amp;usg=AOvVaw35QFhDftCTlCcdFpQ3oFZ6"><span style="color: #873e90"><strong>Exeliom Biosciences</strong>’</span></a> Two additional Phase II studies evaluated EXL01 in hepatocellular carcinoma in combination with an ICI and one in postoperative Crohn&#8217;s disease.</li>
</ul>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>New spinouts on the scene</em></strong></span></h3>
<p>Despite the <strong>challenging fundraising landscape</strong>, 2024 saw the emergence of several <strong>promising biotech spinouts</strong>:</p>
<ul>
<li><strong>Ostia Biosciences</strong> (University of Toronto) – Developing probiotics producing novel antimicrobials, with trials starting in early 2025.</li>
<li><strong>32 Biosciences</strong> (Ginkgo Bioworks) – Focused on diagnostics and therapeutic modulation of bacterial virulence.</li>
<li><strong>Taylored Biotherapeutics</strong> (UCalgary) – Targeting the gut-brain axis for mental health applications.</li>
<li><strong>Florey Biosciences</strong> (Harvard Wyss) – Innovating with engineered yeast strains to address antibiotic-induced microbiome disruptions.</li>
<li><strong>Concordance Therapeutics</strong> are developing smart bacteria that localize to disease sites in the gut, consuming toxic metabolites and converting them into anti-inflammatory compounds.</li>
</ul>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>The Consumer Microbiome Market </em></strong></span></h3>
<p>In 2024, the consumer microbiome market experienced significant momentum, driven by groundbreaking innovations and product launches from key players in the field. Next-Generation Probiotics (NGPs) continue to gain traction, offering targeted solutions for metabolic health, gut health, and women’s health.</p>
<p>Companies like <a href="https://pendulumlife.com/">Pendulum Therapeutics</a> have showcased the potential of precision probiotics with products designed to address metabolic pathways. Similarly, Z-Biotics has expanded its footprint with innovative GMO-based probiotic solutions, addressing emerging consumer needs in metabolic health. <a href="https://seed.com/">Seed Health</a>, on the other hand, has made notable progress in women’s health with their vaginal synbiotic, setting new standards for efficacy in microbiome-focused solutions.</p>
<p>These developments underscore the growing maturity of the NGP market, where science-backed innovation continues to drive both clinical and commercial success on a global scale.</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>Biose’s year in review </em></strong></span></h3>
<p>Reflecting on <strong>2024</strong>, I am incredibly proud of the achievements of our team at <strong>Biose Industrie</strong>:</p>
<ul>
<li><strong>600+ bacterial strains manufactured</strong>.</li>
<li><strong>80+ drug substance batches</strong> and <strong>25+ clinical drug product batches produced</strong>.</li>
<li><strong>10 million finished products</strong> delivered globally.</li>
<li><strong>New major and fantastic clients onboarded</strong>, reflecting our <strong>growing global reputation</strong>.</li>
</ul>
<p>Looking ahead, we are actively preparing for a<strong> Pre-Approval Inspection (PAI) by the FDA</strong>. This preparation is closely aligned with the clinical advancements of our clients’ programs and represents a critical milestone in enabling commercial manufacturing of approved therapies.</p>
<p>We will also be <strong>expanding of our Boston laboratory in 2025 to serve as a small-scale GMP Phase 1 product manufacturing suite</strong>, complementing its state-of-the-art R&amp;D services.</p>
<p>Furthermore, we are heavily investing in cutting-edge technologies to enhance both efficiency and scalability. This includes advanced fermentation techniques, optimized anaerobic production processes, innovative lyophilization strategies, and real-time quality monitoring systems to guarantee precision at every stage of production.</p>
<p>&nbsp;</p>
<h3><span style="color: #873e90"><strong><em>Signing o</em></strong><strong><em>ff</em></strong></span></h3>
<p>Despite difficulties and challenges faced by the microbiome field, <strong>2024 will remain for me as a pivotal and extremely significant year</strong> for our industry, as it is the year in which defined LBPs showed therapeutic reality.</p>
<p>With <strong>significant clinical trial results, significant investments from the public and private sectors, new company formations and good science continuing to emerge</strong>, it is important that stakeholders of the industry continue to focus on their end goal, which is ultimately bringing new therapies to patients in need.</p>
<p>I can say with certainty that this is the goal which <strong>continues to drive the team at Biose Industrie to maintaining the gold standard in bacterial manufacturing.</strong></p>
<p>&nbsp;</p>
<p>With this, I would like to wish all our <strong>friends, colleagues, clients and collaborators a very successful 2025!</strong></p>
<p>&nbsp;</p>
<p>Yours Sincerely</p>
<p><strong>Adrien Nivoliez</strong></p>
<p><strong>CEO</strong></p>
<p><strong>Biose Industrie</strong></p>
<p>The post <a href="https://www.biose.com/29045-2/">Microbiome Wrapped 2024 – A Year in Review &amp; What’s Next</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Our highlights from Global Engage’s 12th Microbiome &#038; Probiotics R&#038;D and Business Collaboration Forum</title>
		<link>https://www.biose.com/our-highlights-from-global-engages-12th-microbiome-probiotics-rd-and-business-collaboration-forum/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Thu, 05 Dec 2024 12:13:39 +0000</pubDate>
				<category><![CDATA[Non classé]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=29017</guid>

					<description><![CDATA[<p>On October 17 &#8211; 18 the Biose team travelled to San Diego for Global Engage’s 12th Microbiome &#38; Probiotics R&#38;D and Business Collaboration Forum. Covering everything from the gut-brain axis [&#8230;]</p>
<p>The post <a href="https://www.biose.com/our-highlights-from-global-engages-12th-microbiome-probiotics-rd-and-business-collaboration-forum/">Our highlights from Global Engage’s 12th Microbiome &amp; Probiotics R&amp;D and Business Collaboration Forum</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>On October 17 &#8211; 18 the Biose team travelled to San Diego for Global Engage’s 12th Microbiome &amp; Probiotics R&amp;D and Business Collaboration Forum. Covering everything from the gut-brain axis to microbiome market trends, the team enjoyed two days of meetings, interesting talks and networking.</p>
<p>This edition signified an expansion of the event’s coverage of women’s and infant health areas. A highlight of which was undoubtedly UCSF’s Craig Cohen who gave an insightful keynote on the development of live biotherapeutic products for bacterial vaginosis and HIV susceptibility.</p>
<p>Other subject areas covered at this year’s forum included “gut microbiota for health &amp; disease”, “gut-brain axis”, “regulation and manufacture”, “probiotics, personalised nutrition &amp; cardiometabolic diseases”.</p>
<p>On the morning of day one, Biose’s, CEO, Adrien Nivoliez was honoured to present on the CMC challenges for LBP and next-generation probiotic manufacturing. He was also pleased to contribute Biose’s expertise on a LBP manufacturing panel, alongside Bharat Dixit of Adiso Therapeutics and Ryan Garrett of Vedanta Biosciences.</p>
<p>We spoke to the event team to get their personal highlights from the forum:</p>
<ul>
<li>“Longitudinal profiling of the microbiome at four body sites reveals core stability and individualized dynamics during health and disease”, <strong>Xin Zhou</strong>, Research Scientist, <em>Snyder Lab, Stanford</em></li>
</ul>
<p>Zhou described his work tracking the human microbiome over a six-year period in 86 individuals across four body sites. His results revealed stable, individualised, bacterial signatures that varied in stability depending on site. Additionally, his work found a relationship between host insulin-resistance and microbiome compositions, with insulin resistance resulting in disrupted stool and skin microbiome stability.</p>
<ul>
<li>“Trials To Testimonials: A Probiotic for Autism”, <strong>Noelle Patno</strong>, Chief Scientific Officer, <em>Bened Life</em></li>
</ul>
<p>The applicability of psychobiotics to alleviate autism-associated symptoms was at the centre of Patno’s talk. Patno described several trials conducted with Bened Life’s lead probiotic product, PS128, that found it reduced ASD-symptomology in children through increased attention, improvements in social communication skills, and a reduction in anxiety.</p>
<ul>
<li>“My Baby Biome Study: A DataDriven Approach to Infant Probiotic Development”, <strong>Pedro Torres</strong>, Director, Bioinformatics and Data Science, <em>Persephone Biosciences</em></li>
</ul>
<p>Torres outlined Persphone’s development of new infant probiotics, powered by its “my baby biome” study to identify biomarkers for infant gut microbiome health. From this study, Persephone identified three distinct infant enterotypes: one Bifidobacterium dominated, one Bacteroides dominated, and one Proteobacteria/Firmicute dominated . The research also found microbiome composition influences the microbial-beneficial impact of breast milk. Torres stated Persephone will launch an infant synbiotic in early 2025, developed with the information gathered through this study.</p>
<ul>
<li>The Potential of Live Biotherapeutic Products to Optimize the Vaginal Microbiome to Improve Reproductive Health”, <strong>Craig R. Cohen</strong>, Professor, Department of Obstetrics, Gynaecology &amp; Reproductive Sciences, <em>University of California San Francisco</em></li>
</ul>
<p>Cohen addressed the limitations of current bacterial vaginosis (BV) treatments and explored novel treatments. He described the high recurrence rates of BV and the potential for live biotherapeutic products to treat it. The development and clinical trials of L. <em>crispatus</em> CTV-05 were discussed, showing promising results in reducing BV recurrence and maintaining vaginal colonization. A randomised, placebo-controlled phase 3 clinical trial is in the pipeline.</p>
<p>The post <a href="https://www.biose.com/our-highlights-from-global-engages-12th-microbiome-probiotics-rd-and-business-collaboration-forum/">Our highlights from Global Engage’s 12th Microbiome &amp; Probiotics R&amp;D and Business Collaboration Forum</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>Scaling Multi-Strain LBPs: A Journey Between Microbiotica and Biose Industrie</title>
		<link>https://www.biose.com/scaling-hard-to-culture-multi-strain-lbps-a-journey-between-microbiotica-and-biose-industrie/</link>
		
		<dc:creator><![CDATA[Biose Editor]]></dc:creator>
		<pubDate>Thu, 10 Oct 2024 12:38:21 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=28883</guid>

					<description><![CDATA[<p>Introduction Working to scale microbial strains from the gut microbiome can be a challenging feat. Selecting the right culturing conditions requires extensive experience, the right equipment, and a finely tuned [&#8230;]</p>
<p>The post <a href="https://www.biose.com/scaling-hard-to-culture-multi-strain-lbps-a-journey-between-microbiotica-and-biose-industrie/">Scaling Multi-Strain LBPs: A Journey Between Microbiotica and Biose Industrie</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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										<content:encoded><![CDATA[<p><strong>Introduction </strong></p>
<p>Working to scale microbial strains from the gut microbiome can be a challenging feat. Selecting the right culturing conditions requires extensive experience, the right equipment, and a finely tuned approach. For some, without the right know-how it might even seem impossible.</p>
<p>Now imagine the challenge of having to simultaneously scale two products consisting of over 17 separate strains…which is exactly what Microbiotica had to do with it’s two live biotherapeutic programs: <em>MB097 </em>and <em>MB310</em>.</p>
<p>Biose had the privilege of working with Microbiotica to overcome this challenge and get these programs to clinical scale for Phase 1b clinical trials.</p>
<p><strong><em>Microbiotica precisely links bacterial signatures to clinical outcomes </em></strong></p>
<p>Microbiotica is a spin-out from the world-renowned Wellcome Sanger Institute, drawing on 10 years of microbiome research experience. The compositions of their defined live biotherapeutics are selected from bacterial signatures found in successful clinical outcomes in defined patient groups.</p>
<p><strong><em>MB097 boosts immune checkpoint inhibitor response and MB310 modifies ulcerative colitis</em></strong></p>
<ul>
<li>MB097 is a nine strain LBP, made up of strains identified in clinical responders to ICI in multiple melanoma patient datasets. In mice tumour models combined anti-PD1 and MB097 therapy shows significantly higher survival rates compared to anti-PD1 therapy alone.<strong>
<p></strong></li>
<li>MB310 is an eight strain LBP composed of bacteria identified from patients who responded well to FMT in a placebo-controlled Ulcerative Colitis trial. Assays using human immune cells and epithelial cell lines suggest that MB310 may work by promoting intestinal barrier repair and inducing immune homeostasis to modify the harmful proinflammatory responses in the gut of UC patients.</li>
</ul>
<p><strong><em>The journey to scale was resource intensive and difficult</em></strong></p>
<p>When Microbiotica approached Biose Industrie, they needed to scale-up these two candidates ready for their respective phase 1b clinical trials. The collaboration was challenging, but ultimately successful.</p>
<p>During transfer of materials from client to Biose it was identified that the process needed to be adapted for scale-up and GMP.</p>
<p><strong><em>Careful tweaking and iterations led to a hard-to-scale microbe achieving exponential growth </em></strong></p>
<p>One key step in this was figuring out how to culture a completely novel strain discovered by Microbiotica, MI10. This obligate anaerobic strain showed very little growth under initial culturing. Microbiotica and Biose worked closely together, running 12 production runs over a 5-month period. The process required assessment of multiple variables including raw materials, culture conditions, anaerobic gas, and process parameters to get it right. Eventually, the collaboration identified a robust and reproducible process, ready for clinical batch manufacturing</p>
<p><strong><em>Biose integrated brand-new equipment to ensure scale could be reached</em></strong></p>
<p>Another difficulty Biose faced in scaling-up the production was that some of the strains were not growing under the existing anaerobic cabinets. Biose took action to integrate brand new equipment into the facility to overcome this. This included the integration of new solid plates in a temperature regulated and hygrometric environment, which allowed the growth and handling of these strains.</p>
<p><strong><em>Biose and Microbiotica overcame the manufacturing challenges and are ready for the Phase 1 trials</em></strong></p>
<p>Through a close working relationship with Microbiotica, extensive experience in microbial manufacture, and an agile approach to getting these candidates ready for clinical batch scale, the manufacturing projects for MB097 and MB310 have been a success. Both clinical batches are ready for the Phase 1b European clinical trials, produced by Biose’s and Microbiotica’s jointly created manufacturing process.</p>
<p>Biose looks forward to the clinical read-outs from both trials and is excited about its continued partnership with Microbiotica</p>
<p>Having trouble scaling up your live biotherapeutic product? <a href="r.ellis@biose.com">Contact us for a chat here.</a></p>
<p>The post <a href="https://www.biose.com/scaling-hard-to-culture-multi-strain-lbps-a-journey-between-microbiotica-and-biose-industrie/">Scaling Multi-Strain LBPs: A Journey Between Microbiotica and Biose Industrie</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>A Powerful Partnership: Biose and Biomica took to the stage at the 2024 Pharmabiotics Event in Lille</title>
		<link>https://www.biose.com/a-powerful-partnership-biose-and-biomica-took-to-the-stage-at-the-2024-pharmabiotics-event-in-lille/</link>
		
		<dc:creator><![CDATA[Biose Industry]]></dc:creator>
		<pubDate>Thu, 18 Apr 2024 07:40:15 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=28250</guid>

					<description><![CDATA[<p>One in two people will develop cancer in their lifetime. Given this startling fact, developing novel treatments to improve cancer survivability is vital.</p>
<p>The post <a href="https://www.biose.com/a-powerful-partnership-biose-and-biomica-took-to-the-stage-at-the-2024-pharmabiotics-event-in-lille/">A Powerful Partnership: Biose and Biomica took to the stage at the 2024 Pharmabiotics Event in Lille</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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			<p>One in two people will develop cancer in their lifetime. Given this startling fact, developing novel treatments to improve cancer survivability is vital. Recent evidence has indicated a role for the gut microbiome in modulating cancer therapy response. For example, FMT trials in humans have specifically shown transferring faecal microbiome material from anti-pd-1 responders into non-responders can improve checkpoint inhibitor (ICI) therapy response and efficacy.</p>
<p>Biomica, a clinical phase, Israel-based biopharmaceutical company, and partner of Biose Industrie, are trail-blazing microbiome therapeutic development for improving immuno-oncological treatment. A subsidiary of Evogene, Biomica leverage a computational biology approach to identify and develop rationally designed live biotherapeutic products with a focus on treating gastrointestinal and immuno-oncological indications. Their lead candidate BMC128, is a phase 2, four-strain LBP intended to improve response rates for ICI in solid tumours.</p>
<p>Biose Industrie were pleased to present with Biomica for a presentation on our joint work to get BMC128 through the clinic, at the recent Pharmabiotics Conference &amp; Partnering 2024 event in Lille.</p>

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			<p>Shiri Meshner, Vice President of R&amp;D, of Biomica presented the first half of the talk. Meshner described how Biomica uses a proprietary computational platform, PRISM, to design consortia-based live biotherapeutics with the fewest number of strains for maximal function. Biomica’s immuno-oncology drug candidate, BMC128, is a combination of 4 specific functional bacteria which are elevated in human responders to ICI, Meshner explained.</p>
<p>In pre-clinical models for breast cancer and melanoma BMC128 administration prior to and in combination with anti-pd-1 significantly improved anti-tumour activity. Meshner cited an overall reduction in systemic immune inhibition, along with an induction of systemic and intra-tumour immune penetration and activation as key to the drug’s mechanism of action.</p>
<p>Meshner rounded off the first half of the presentation by discussing Biomica’s in-human trial. Biomica concluded its phase 1 open-label study in 2022, which examined the safety and tolerability of BMC128 in patients with non-small cell cancer, melanoma, or renal cell carcinoma. The phase 1 study indicated an excellent safety profile and positive preliminary results.</p>
<p>Biose’s very own Claire Derlot, Chief Business Officer, then took to the stage. Derlot described the close working relationship between Biomica and Biose Industrie, with Biose assisting Biomica at every step of their manufacturing journey. Biose first engaged with Biomica in 2020 and have since scaled BMC128 from small preclinical batches all the way up to GMP clinical manufacture, in reactors of up to 3500 Litres, for Biomica’s phase 1 trial.</p>
<p>One challenge in manufacturing BMC128 for the phase 1, Claire described, was ensuring ileal release of bacteria. To overcome this challenge, Biose performed a tailored formulation screening using an in vitro gut model system and BMC128. Biose then used the results of the experiment to design a delayed-release banded capsule which delivers the bacteria in the late intestine for optimal efficacy in humans.</p>
<p>Finalising the presentation Derlot described how Biose will work with Biomica to navigate upcoming challenges for BMC128 including: process optimisation for drug substance and drug product, DS and DP GMP manufacturing, and regulatory support for the CTD filing to the FDA (submission in H2 2024).</p>
<p>Biose look forward to continuing our journey with Biomica and are excited for the outcomes of their upcoming phase 2 clinical trial.</p>

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</div><p>The post <a href="https://www.biose.com/a-powerful-partnership-biose-and-biomica-took-to-the-stage-at-the-2024-pharmabiotics-event-in-lille/">A Powerful Partnership: Biose and Biomica took to the stage at the 2024 Pharmabiotics Event in Lille</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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		<title>11 February: International Day of Women and Girls in Science</title>
		<link>https://www.biose.com/11-february-international-day-of-women-and-girls-in-science/</link>
		
		<dc:creator><![CDATA[nickgallo]]></dc:creator>
		<pubDate>Sun, 11 Feb 2024 15:53:13 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.biose.com/?p=26981</guid>

					<description><![CDATA[<p>Today, on the International Day of Women and Girls in Science 2024, we celebrate the importance of achieving gender equality at work and we recognize the role that women and girls play in science and technology.</p>
<p>The post <a href="https://www.biose.com/11-february-international-day-of-women-and-girls-in-science/">11 February: International Day of Women and Girls in Science</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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										<content:encoded><![CDATA[<p>Today, on the International Day of Women and Girls in Science 2024, we celebrate the importance of achieving gender equality at work and we recognize the role that women and girls play in science and technology.</p>
<p>At Biose Industrie we are proud that half of our employees are women &#8211; watch the video below to hear their thoughts on gender challenges within biotech.</p>
<p><iframe loading="lazy" title="IV2" width="640" height="360" src="https://www.youtube.com/embed/6Q0z2kDCWLE?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe></p>
<p>The post <a href="https://www.biose.com/11-february-international-day-of-women-and-girls-in-science/">11 February: International Day of Women and Girls in Science</a> appeared first on <a href="https://www.biose.com">Biose Industrie</a>.</p>
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