Bacillus subtilis DSM 21097 – Analyses & Documentation | VIDABIOMA

Bacillus subtilis DSM 21097 · Strain identity · Safety testing · Traceability

When a product contains a defined bacterial strain, the name Bacillus subtilis alone is not enough for us.

What matters is which strain is actually used, how its identity is documented, which quality and safety tests have been carried out, and whether its path through to the finished product can be traced.

A strain with a clearly defined identity

The Bacillus subtilis used in our products is not identified merely at species level.

Our products are centred around the defined strain:

Its earlier strain designation is B-11. Later documentation confirms that B-11 corresponds to DSM 21097.

This means the specific Bacillus subtilis strain behind our quality documentation and our products is clearly defined.

From Russian research to DSM 21097

The history of this strain began long before its later deposit in Germany.

Its origins can be traced back to Russian Bacillus research around 1990. The Bacillus subtilis strain later designated B-11 was selected and further investigated as part of extensive microbiological work.

The formal records available to us today begin in 2008.

B-11 was microbiologically examined and documented in Germany. We also hold documentation relating to its deposit in a Russian culture collection.

The strain was subsequently deposited for long-term preservation with the German Collection of Microorganisms and Cell Cultures (DSMZ).

This documented record makes it possible to trace the strain from its scientific origins in Russia, through the designation B-11, to its deposit under the designation DSM 21097.

Bacillus subtilis within the EFSA QPS framework

The European Food Safety Authority EFSA includes Bacillus subtilis within its Qualified Presumption of Safety framework, commonly referred to as QPS.

QPS does not assess or authorise a specific food supplement. Instead, it provides a scientific framework for evaluating defined groups of microorganisms and the safety qualifications that apply to them.

For Bacillus strains, particular attention is given to emetic toxic activity and enterotoxic activity.

Testing for toxigenic properties

DSM 21097 has been subjected to laboratory testing covering a number of toxigenic and microbiological parameters.

Antibiotic susceptibility documented

DSM 21097 has also undergone antibiotic susceptibility testing.

The documentation includes both susceptibility testing and a later MIC-based assessment.

These analyses are an important part of strain-specific quality and safety documentation.

Testing for biogenic amines

In a separate laboratory analysis, DSM 21097 material was tested for five biogenic amines.

The values shown relate to the specific sample tested. They demonstrate that this group of compounds was also specifically included in the quality testing programme.

Microbiological quality

The available certificates of analysis do more than simply state the Bacillus subtilis concentration.

They also include testing for a range of additional microbiological quality parameters.

Verified spore concentration

Certificates of analysis are available for DSM 21097 source material, documenting both the strain designation and the concentration of viable microorganisms.

This means that a key quality parameter for the subsequent dosage is measured analytically rather than assumed.

Available certificates of analysis for DSM 21097 material document very high concentrations of viable units.

From DSM 21097 to the finished capsule

For our high-dose Bacillus subtilis products, Bacillus subtilis DSM 21097 is incorporated into a defined Moringa premix.

For this purpose, 6 kg of Moringa powder are enriched with DSM 21097. This defined premix is then transferred to our contract manufacturer.

There it is blended homogeneously with the other ingredients according to our production formulation and then encapsulated.

One production batch yields 100,000 capsules.

This means that we document not only which strain is used, but also the route from the defined DSM 21097 strain through the enriched premix to the dosage in the finished product.

A traceable quality chain

What documentation is available?

Our quality documentation for Bacillus subtilis DSM 21097 covers a number of different areas.

Analysis reports, strain documentation and product-specific production records form part of our internal quality documentation.

Some of these documents contain confidential information or are subject to restrictions on disclosure and publication imposed by the issuing institutions, laboratories or contractual partners.

For this reason, the original documents are not made publicly available online. Individual documents may be made available for inspection or disclosure only where there is a legitimate interest, following review of the specific request and subject to applicable confidentiality and usage restrictions.

For us, quality does not begin with the capsule.
It begins with the identity of the strain.