The human microbiome as a key lever for health and performance
The human microbiome consists of trillions of microorganisms that affect not only the gut, but the health of the entire body and our overall well-being. For example, the gut microbiome modulates the immune system, skin, metabolism, and brain far beyond digestion. As more people become aware of the vital role the gut microbiome plays in our overall health, there is growing interest in how nutrition can positively influence our microbiome. As a result, the growing demand for microbiotic products such as prebiotics and probiotic supplements is rising.
Our B4U® microbial strains
Bacillus subtilis, the 2023 Microbe of the Year according to the Association for General and Applied Microbiology (VAAM), is a highly versatile and well‑studied microorganism widely used across biotechnology, life sciences, nutrition, agriculture, and industrial applications. As a trusted supplier of Bacillus subtilis solutions, we support our customers with high‑quality strains, tailored products, and deep technical expertise across development and manufacturing.
Known for its robustness, proven safety profile (GRAS status), and broad functional potential, Bacillus subtilis is ideally suited for innovative and sustainable applications. Our capabilities enable customers to harness the full value of this powerful bacterium in a reliable, scalable, and regulatory‑compliant manner. From research to full‑scale production, we are your expert partner for Bacillus subtilis‑based solutions.
Strain properties of Bacillus subtilis DSM 32315
- QPS-listed species compliant with EFSA qualifications
- Self-affirmed GRAS status for use in foods and dietary supplements
- FDA-registered manufacturing facility
- Nagoya compliant
- Remarkable heat and process stability plus storage stability
- Extraordinary resistance to gastric and bile acid
- Inhibitory to many known pathogens (in vitro)
- Produces high amounts of lactic acid
- Has been clinically studied in combination with Alanyl-glutamine for its effect on glucose metabolism and lipid levels
The B4U®21 strain was investigated in pre-clinical and clinical studies
- Tom Dieck, H., Schön, C., Wagner, T., Pankoke, H. C., Fluegel, M., & Speckmann, B. (2021)
A Synbiotic Formulation Comprising Bacillus subtilis DSM 32315 and L-Alanyl-L-Glutamine Improves Intestinal Butyrate Levels and Lipid Metabolism in Healthy Humans
Nutrients, 14(1), 143 - Kordowski, A., Tetzlaff-Lelleck, V. V., Speckmann, B., Loh, G., Künstner, A., Schulz, F., Schröder, T., Smollich, M., Sina, C., & Tom Dieck, H. (2022)
A nutritional supplement based on a synbiotic combination of Bacillus subtilis DSM 32315 and L-alanyl-L glutamine improves glucose metabolism in healthy prediabetic subjects - A real-life post-marketing study
Frontiers in nutrition, 9, 1001419 - Tom Dieck, H., Tomassi, D., Postrach, E., Ehring, E. (2026)
Effects of targeted colonic synbiotic supplementation with Bacillus subtilis DSM 32315 and L-alanyl-L-glutamine on mental wellbeing: An open-label pilot study
Global Translational Medicine, DOI:10.36922/GTM025460086
Bacillus megaterium is a well‑established microbial production host valued for its large cell size, exceptional genetic stability, and strong performance in industrial biotechnology. As a specialized provider of Bacillus megaterium‑based solutions, we enable efficient development and manufacturing of enzymes, recombinant proteins, and other biologically derived products.
This organism is particularly suited for applications requiring high secretion yields, straightforward downstream processing, and reliable scale‑up. Leveraging our deep process knowledge, robust strain portfolio, and manufacturing expertise, we help customers translate Bacillus megaterium’s biological advantages into commercially viable and regulatory‑ready solutions. We support projects from early development through industrial production with a focus on quality, scalability, and long‑term performance.
Strain properties of Bacillus megaterium DSM 32963
- Tested to the EFSA safety standard/QPS status
- Self-affirmed GRAS status for use in foods
- Heat and process stability
- Gastric and bile acid resistance
- Specialized pro-resolving mediator (SPM) producer: converts omega-3 fatty acids into anti-inflammatory lipids
- Has been studied in clinical trials for its effect on SPM formation
The B4U®63 strain was investigated in preclinical and clinical studies
- Speckmann et al.
Synbiotic Compositions of Bacillus megaterium and Polyunsaturated Fatty Acid Salt Enable Self Sufficient Production of Specialized Pro-Resolving Mediators
Nutrients. 2022 May 28;14(11):2265 - Speckmann, B., Wagner, T., Jordan, M.P., Werz, O., Wilhelm, M., Tom Dieck, H., Schön, C. (2024)
Synbiotic Bacillus megaterium DSM 32963 and n-3 PUFA Salt Composition Elevates Pro-Resolving Lipid Mediator Levels in Healthy Subjects: A Randomized Controlled Study, 16 (9) - Speckmann, B., Jordan, M.P., Werz, O., Hofstetter, R.K., Ehring, E., Vogel, M.-V., Venema, K. (2025)
Bacillus megaterium DSM 32963 Enhances Specialized Pro-Resolving Mediator Production from an n-3 PUFA Salt in a Dynamic Model of the Human Intestine, 15 (2)
Frequently asked questions (FAQ)
B4U®21 is Evonik's proprietary Bacillus subtilis DSM 32315 strain. As a naturally spore-forming microorganism, it was selected to combine process stability, formulation flexibility, and strain-specific functionality.
The strain has been investigated in pre-clinical and human studies and is suitable for a broad range of microbiome-focused product concepts.
Not all Bacillus subtilis strains are the same. B4U®21 was selected from a large strain discovery program involving more than 500 Bacillus candidates.
Key differentiators include:
- Rational and vigorous strain selection process
- Documented scientific evaluation
- Nagoya-compliant sourcing and development
- EU production and quality standards
- Strong regulatory profile
- Excellent process and storage robustness
- Broad formulation compatibility
By combining Nagoya-compliant sourcing, robust spore technology, and documented scientific evaluation, B4U®21 helps reduce complexity throughout formulation development, supplier qualification, and commercial product implementation.
B4U®21 has been selected and is supplied in accordance with Nagoya requirements, supporting transparent strain origin and traceability.
With its Nagoya-compliant origin and transparent documentation, B4U®21 helps simplify ingredient qualification and supports efficient product development for global supplement and nutrition brands.
B4U®21 benefits from a strong regulatory foundation:
- Bacillus subtilis is a QPS-listed species under EFSA qualifications
- Self-affirmed GRAS status for food and dietary supplement applications
- Produced in an FDA-registered manufacturing facility
- Nagoya compliant
- Manufactured in the EU
These attributes support international formulation and commercialization strategies.
As a spore-forming probiotic, B4U®21 demonstrates remarkable robustness during:
- Heat exposure
- Manufacturing processes
- Transportation
- Long-term storage
- Resistance to gastrointestinal conditions
This makes the strain particularly suitable for challenging dosage forms and consumer-friendly formats.
B4U®21 is compatible with a wide variety of product concepts, including:
- Capsules
- Tablets
- Gummies
- Sachets
- Stick packs
- Powder blends
- Sports nutrition
- Meal replacement products
- Protein powders
- Functional foods
- Selected beverage applications
- Synbiotic formulations
Its spore-forming characteristics support flexibility across multiple formulation platforms.
B4U®21 demonstrates high resistance to gastric and bile conditions.
This robustness supports survival during gastrointestinal transit and makes Bacillus subtilis DSM 32315 a popular choice for supplement developers seeking highly resilient probiotic solutions.
Yes. B4U®21 can be incorporated into synbiotic concepts alongside selected prebiotics, vitamins, minerals, plant extracts, proteins, and complementary microbial strains.
Its formulation robustness and compatibility make it an attractive ingredient for next-generation microbiome-focused product development.
B4U®21 has been evaluated in pre-clinical and human studies. Research has investigated the strain in combination with L-alanyl-L-glutamine within synbiotic formulations and explored a variety of microbiome-related and metabolic endpoints.
Further technical documentation and scientific references are available upon request.
B4U®21 was selected to address the key challenges of modern probiotic product development:
- Proprietary Bacillus subtilis DSM 32315 strain
- Nagoya-compliant sourcing
- QPS-listed species
- Self-affirmed GRAS status
- Exceptional heat and storage stability
- Broad application flexibility
- Suitable for gummies and other challenging formats
- EU manufacturing and quality standards
- Scientific and technical support from Evonik
Does your company want to bring dietary supplements to the next level? Are you interested in finding out more about our solutions?
Susanne Pluta (Director Consumer Products)
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Products and ingredients presented by Evonik are intended for use in dietary supplements, food, and nutrition applications. They are not intended to diagnose, treat, cure, or prevent any disease. Any statements contained herein should not be interpreted as approved health or medicinal claims and have not necessarily been evaluated by the U.S. Food and Drug Administration or other relevant regulatory authorities worldwide.
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