Research and development, scientific excellence
We create clinically validated nutrition solutions that support health throughout life. Inspired by nature, we lead the way in microbial biotransformation and advanced fermented ingredient technology. Our R&D capabilities are defined by our commitment to scientific research, extensive clinical validation, and proprietary expertise. Partner with us to create effective, market-ready nutrition and health solutions with proven efficacy and pharmaceutical-grade safety.
We formulate, substantiate, and validate
At Gnosis, our nutritional ingredients and formulation services are designed with real-world efficacy in mind. As industry leaders in biotransformation and fermentation technology, our workflows are informed by an impressive roster of academic collaborations and clinical validation studies. Our comprehensive approach covers three key pillars:
Product formulation & stability testing
We consider clinical validation endpoints from the very beginning of our workflow. When formulating novel products, we harness natural biotransformation methods to produce highly bioavailable and functional ingredients suitable for supplement or food ingredient applications. This approach ensures maximum regulatory compliance and optimal effects in clinical trials down the line.
Our advanced FDA and AIFA-approved microbiology labs, equipped with highly sensitive analytical instrumentation, are designed to address the complexities of microbial handling and rigorous testing of fermented products. Our preparatory-scale systems are optimized for seamless scalability from initial testing into commercial workflows.
Scientific substantiation & research
Scientific substantiation is a core priority at Gnosis by Lesaffre. It helps us and our partners provide irrefutable proof of product benefits, build consumer trust, and ensure regulatory compliance. We achieve this by collaborating with an impressive roster of world-class academic institutions, clinical centers, and universities, supported by our internal team of technical experts.
We constantly integrate new partners and technologies to ensure the latest scientific precision is applied. For example, probiotics are live microorganisms, and one of their key features in promoting health benefits is their ability to survive different environmental stresses during digestion.
The TNO Gastro-Intestinal Model (TIM), developed by TNO, Zeist, the Netherlands, was used to conduct survival assays of S. boulardii CNCM I-3799 and S. cerevisiae CNCM I-3856. The multi-compartmental model replicates the key factors of digestion as closely as possible to physiological reality and is just one tool we use to analyze the robustness of our ingredients.
Furthermore, we maintain strong partnerships with influential associations and organizations, including the Gut Microbiota For Health (GMFH), the International Probiotics Association (IPA), and the French Gut.
Clinical trials & validation
We are active collaborative partners in the sponsorship and leadership of numerous clinical trials globally. Our commitment to rigorous ethics and methodological standards is reflected in our published clinical research, which appears in several high-impact-factor peer-reviewed research journals.
Our scalable facilities and capacity are designed to support the development, roll-out, and production needs of large-scale, long-term clinical trials. Furthermore, as experts, we have extensive experience navigating complex ethical and regulatory standards in research, ensuring we are well-positioned to expedite the process and help create products that reach market-readiness sooner.
From strain to study, we make research a priority
As a recognized leader in biotransformation and fermentation technology, we prioritize scientific and clinical rigor across strain selection, study design and implementation. Our commitment is woven into our workflow and is exemplified by our impressive range of predesigned ingredients, products, as well as our bespoke custom service offerings. By actively partnering with multiple academic institutions and global networks to sponsor high-quality clinical validation studies, we have not only accelerated our own product development pipeline but also continually expanded upon a comprehensive scientific package that benefits the holistic health industry.
Our scientific teams & ecosystem of expertise support the innovation lifecycle
Not only do we pride ourselves on our commitment to supporting academic research, but we’re also confident in our own internal expertise. Our three-arm research and development team consists of over 40 scientists, in addition to solutions experts; its mission is clear – to provide deep insights into the distinct health benefits and applications of Gnosis products, driving continuous improvement, and supporting evidence-based decision-making. Its three divisions include Exploratory Research, Process and Product Development, and Customer Solution Centre.
A cycle of innovation, not a sequence
We do not wait for a product to be finished to ask if it is compliant or effective. The collaboration starts at the very spark of an idea.
When our Exploratory Research team investigates emerging technologies and new ingredients, they are already in sync with the Substantiation team. While researchers explore the “how,” the Substantiation experts provide the “why,” offering a clear view of the competitive science landscape and identifying true health benefit opportunities.
Simultaneously, the regulatory dimension is integrated from day one. Our R&D teams provide scientific support to Regulatory Affairs right from the discovery phase to ensure innovation alignment and compliance. This means we don’t just build products that work; we build products that are designed to succeed in a complex global regulatory environment.
The technical engine of scientific proof
For our products to carry strong health claims, they must be backed by undeniable proof of safety and efficacy. This is where the partnership becomes truly hands-on.
The Substantiation and Medical Affairs teams lead the definition, implementation and valorization of human-based research, ranging from randomized clinical trials to real-world evidence studies. However, these studies rely entirely on the precision of R&D’s Process and Product development Team, which consists of:
- Ingredient Formulation & Chemistry, Fermentation, and Product Recovery teams that design the specific forms needed to guarantee the right absorption profile (bioavailability) and stability of the nutrient. Without this technical precision, a clinical trial cannot yield valid results, and the consumer cannot expect the better possible effect.
- Ingredient Formulation & Chemistry and Microbiology & Genetics teams that design, characterize and produce the reference materials and strains used in the development of the ingredients, either pure actives or biotic strains.
- Analytical Development team that creates and validates the methods used to characterize pure ingredients and formulations within complex matrices.
This cross-functional effort ensures that when we claim a health benefit and that when we access a market, it is based on “Scientific Integrity” and “Evidence-based decision making”.
Building the path to market access
Regulatory Affairs is the backbone of our market access, but they do not work in isolation. Their ability to secure approvals and maintain compliance is fueled by a constant stream of high-level technical data generated by R&D.
Every team in R&D contributes to this Regulatory Readiness:
- Microbiology & Genetics team drafts technical sections for regulatory documentation and conducts genotyping and stability studies to secure our strains.
- Ingredient Formulation & Chemistry team provides the essential data for Drug Master Files (DMF) and safety protocols.
- Analytical Development performs stability studies strictly according to ICH official guidelines, ensuring our data stands up to the scrutiny of global authorities.
- Exploratory team ensure that the ingredients are backed by rigorous toxicological assessment package compliant with regional standards (e.g., OECD guidelines) and characterized underlying mechanisms of action.
This collaboration allows the Scientific & Regulatory Affairs group to represent Gnosis effectively in front of scientific and regulatory authorities, armed with a robust, transparent, and technically sound substantiation package.
Delivering value to our customers
Ultimately, this unified workflow is designed to serve our partners and customers. The Customer Solutions Center (CSC) acts as the bridge, organizing the vast scientific expertise of the R&D department to communicate technical aspects effectively. By aligning the Strategy & Innovation directions with Marketing needs and Regulatory opportunities, CSC ensures that we market the technical benefits of our ingredients as strongly as we market their health benefits and is the privileged partner of our customers for bringing technical and scientific data, support end-product development and market access.
Nutrition research & development in action
We believe that the future of wellness is forged at the intersection of nature and advanced science. Our research is not just commercially strategic—it is a mission to explore the full potential of human metabolic health. By seamlessly integrating high-impact scientific research with the latest market insights, we translate our molecular understanding into tangible, clinically validated ingredients. This work addresses the full spectrum of health, from fortifying the foundational resilience of the gut microbiota to pioneering nutraceutical systems for metabolic support and cardiovascular longevity. Here are a few key examples of our work, reflecting our range of vitamin, yeast, and bacterial probiotic products:
Case study 1: Metabolic & heart health support with MenaQ7®
MenaQ7® is our patented, highly bioavailable Vitamin K2 formula derived from fermented chickpeas. Clinical data, including key findings from the VitaK-CAC Trial, demonstrate that supplementation with MenaQ7® can significantly slow the progression of coronary artery calcification—a primary risk indicator for heart health. This provides a clear, science-backed path for proactively supporting long-term cardiovascular resilience.
Case study 2: Gut health & well-being with IbSium®
ibSium® is a unique non-GMO probiotic yeast (Saccharomyces cerevisiae CNCM I-3856) that we have selectively developed to deliver targeted relief for irritable bowel syndrome (IBS) and restore balance to the gut-brain axis. Meta-analyses have shown that ibSium® is effective in relieving symptoms in multiple IBS populations, including IBS-C, which has been historically difficult to treat with clinical intervention.
We’re not just science-backed, we’re certified and compliant
All of our commercial development processes—from concepting to manufacturing and rollout—are conducted with the same commitment to scientific rigor that we apply to our product testing and clinical trials. We are not just science-backed; we are science-led, certified, and fully compliant.
We are deeply committed to meeting Global Regulatory and region-specific compliance standards. Our operations hold approvals from major national and supranational regulatory bodies, including the FDA and EFSA. Furthermore, our work conforms to guidelines set out by the International Organization for Standardization (ISO), specifically: ISO 9001:2015 (Quality Management Systems), Hazard Analysis and Critical Control Points (HACCP), and Good Manufacturing Practice (GMP).
Alongside this commitment to compliance, our Quality Control team rigorously ensures that all ingredients are suitable and traceable. This vigilance guarantees that everything we produce is pharmaceutical-grade and optimized for consumer confidence, including GMO-free, vegan-friendly, Halal, Kosher, and ECOCERT certification.
Sustainable innovation: R&D with our planet in mind
At Gnosis, we bring natural, biotransformative fermentation processes into the 21st century using modern, sustainable scientific practices. As we continue to explore the potential of microbial fermentation and biotransformation in nutraceutical product development, we also strive to be industry leaders in green, ethical, and sustainable R&D.
The fermentation processes we employ produce minimal waste and align with our ethos of circular economy advancement. Additionally, we are strategically positioned within the global supply chain infrastructure to mitigate disruptions and ingredient availability risks. In sum, we operate in a manner that is both kind to the planet and accommodating to mass-market demands and economic fluctuations.
Our dual offering, your perfect solution
We are proud to support our research and development partners through a robust dual offering: an impressive selection of predesigned ingredient products for formulators to work with, and an expert portfolio of bespoke, customizable product development services.
We help our clients and partners achieve their entry-to-market goals with lower costs of ownership and instant access to our market-leading expertise across the areas we serve. Our entire suite of solutions has been designed from first principles with the delivery of clinically validated, mass-market appeal in mind. Our solutions are flexible, scalable, and designed to meet your operational, commercial, or blended requirements.
We will work closely with you to ensure the seamless delivery of your project and guide the translation of your idea into an effective nutritional product design.
Ready to explore the forefront of nutrition & health innovation?
Frequently asked questions:
Q: How do you guarantee the efficacy and clinical performance of new ingredients?
Efficacy is guaranteed through rigorous scientific substantiation, including strain or compound characterization, extensive internal testing, and, crucially, active sponsorship of third-party human clinical trials. All key research is peer-reviewed and published in high-impact factor journals.
Q: What advanced in-vitro modelling systems do you employ?
Beyond traditional methods, we utilize multi-compartmental models such as the TNO Gastro-Intestinal Model (TIM), developed by TNO, Zeist, the Netherlands. This model uses data collected from volunteer subjects to replicate the key factors of digestion as closely as possible to physiological reality. It accurately replicates the human gut environment, providing a precise, ethical, and predictive method for substantiating survivability and the robustness of our ingredients.
Q: Do you include animal testing in your novel product R&D pipeline?
We are committed to ethical, sustainable research and to reducing the use of animal models in our R&D pipeline. We actively replace animal models with advanced, non-animal testing alternatives, such as the predictive intestine-on-a-chip model, which provides more accurate and ethical data for substantiation that supports further validation by clinical trials.
Q: How do you manage strain selection and guarantee probiotic stability for shelf life?
Strain viability is ensured through stringent selection and robust stability testing in our advanced microbiology labs. Our decades of expertise in yeast and bacterial fermentation result in pharmaceutical-grade nutra ingredients with guaranteed purity and exceptional long-term shelf stability, even at room temperature. Furthermore, our products can withstand storage and reasonable processing without spoiling or losing efficacy.
Q: What types of products does Gnosis develop?
A: Gnosis creates unique active ingredients, probiotics, and nutritional and functional yeasts through biotransformation and fermentation. These scientifically-validated solutions are tailored for nutraceutical, pharmaceutical, and functional food & beverage brands.