At Chr. Hansen, we pride ourselves on making the journey from STRAIN TO SOLUTION™. To achieve this, we follow a series of important steps to understand the science behind our probiotic strains. This starts in the laboratory in the preclinical phase, where we explore questions such as what the strain is and what probiotic features it has. Strains that are shown to have desirable properties in the preclinical phase can then be taken into production and tested in human studies, to further understand their role in supporting health.
It all starts with carefully selected bacterial strains
Chr. Hansen has a leading collection of bacterial strains that have been isolated or in-licensed from trusted partners. This strain collection is the basis for our development of new probiotic products.
New strains are thoroughly characterized using state-of-the-art genomic analysis and laboratory methods, to ensure they are safe. Genome sequencing allows the most accurate identification of the strain and is an essential part of the safety evaluation. Bioinformatic analyses are also used to search strains for the presence of undesirable genes and markers, to confirm whether the strain is a good candidate for the next stage of screening.
Screening for probiotic features
The next step is to establish whether the strain shows promise as a probiotic, through a range of tests:
- Laboratory methods determine acid and bile tolerance, as well as inhibition of harmful bacteria.
- Human cells and other laboratory-based models are essential to understand any interactions between strain and human.
- Advanced experimental methods are used to test for specific interactions, such as the potential improvement of the intestinal barrier, the specific impact on the immune system, or the production of bioactive molecules.
We can also use bioinformatics to look for the presence of specific genes that are known to be linked to probiotic function. This helps to streamline the process of selecting new probiotic candidates with specific health benefits.
Simulating conditions in the gastrointestinal tract
The next step to test how the probiotic will perform under the conditions in the human gastrointestinal (GI) tract. At Chr. Hansen we are using two unique and very advanced models to simulate this: TIM-1 and TIM-2.
TIM-1 is a validated model that simulates the stomach and small intestine, whereas TIM-2, also a validated model, simulates the colon. Both models are highly reflective of the conditions that are known to be important for probiotic survival and function in the human GI tract. This makes the TIM models extremely valuable for studying the survival of probiotics and how formulation affects survival, the production of specific metabolites, or colonization of the large intestine and the benefits of prebiotics.
In certain limited situations, essential animal studies might be used to confirm laboratory findings of certain probiotic candidates. These studies can be used to increase our confidence that the probiotic will have benefits for human studies. Animal studies can also be helpful to suggest what should be measured in human studies, such as markers of a specific functions, and allow analyses of mode of action.
Upscaling to production
When a probiotic strain has been selected, the production process is developed in order to ensure a stable and highly viable product. For more information on this stage, see Production.
Testing for health benefits: Human studies
Many foods and supplements contain live bacteria, but only bacterial strains with a scientifically supported health benefit may correctly be termed probiotics. These health benefits can be measured in human studies. These are the primary way that we can find out if a new bacterial strain is safe in people, and that the bacterial strain has benefits in terms of supporting human health.
In Chr. Hansen we have dedicated specialists in our state-of-the-art Clinical Development Department, who ensure that our research studies are carefully designed, reviewed and completed according to international, ethical and scientific quality standards.
Partnering with Chr. Hansen
We are pioneering microbial science to improve health. As part of our commitment, we believe in the need to support ethical, independent scientific research conducted by qualified third-party investigators. These collaborations with external partners are essential to our R&D efforts, and we welcome new partnerships with individual investigators and research teams. The value of these collaborations is key to complementing our own scientific studies in understanding the science behind our strains and exploring potential health benefits for people world-wide.
Chr. Hansen may support academia and independent researchers with investigational products, subject to a scientific evaluation and a written agreement. We may offer investigational products and corresponding placebo, or together we may customize a unique probiotic solution or product, for study purpose, that meets your specific needs, including the intended target population, the dosage form and the probiotic health area (i.e. area of intended benefit).
If you would like to hear more about our unique solutions and partnerships, please get in touch.
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