Q&A with a probiotics producer

In this interview with Antonio Del Casale, from Microbion, we ask about the legal status of probiotics, how they are developed and if probiotics is a sustainable industry. The full interview can be found via the PDF link in the Downloads section at the bottom of this Step.

Microbion is a contract research organisation which specialises in molecular microbiology.

How are probiotics developed commercially?

Probiotic strains, yeast or bacteria, are usually isolated from biological samples from healthy people. The type of sample depends on the final application. Faecal strains are used to isolate bacteria for the gut microbiota, skin strains are selected for cosmetics, and so on. Thanks to metagenomic analysis methods, is now possible to monitor the continuously changing microbial communities and take the sample just when the ‘strong’ strains are overtaking the pathogens (harmful organisms) or where the most resilient strains predominate.

Thousands of isolated candidates are screened, searching for the safest and best performing strains. Species on the European QPS list (Qualified Presumption of Safety) can have a shorter safety assessment which includes species and sub-species identification, assessment of antibiotic resistance and the possibility of horizontal gene transfer, and the presence of genes related to the virulence factor of toxins. The safety assessment is then followed by in vitro studies. These are usually assays on tissue cultures, aiming to assess how well the strain adheres to specific human cells, its ability to compete against pathogens, and its ability to activate the specific immune system response. The strain’s ability to survive digestion is a key factor for all probiotics that target the gut, but microencapsulation can help them to reach the gut alive.

Another important aspect of candidate screening is the growth rate of the strain at an industrial scale and its robustness against freeze-dry lyophilisation (a low temperature dehydration technique). Good candidates should be able to grow in low cost media (possibly using agro-food side products such as whey) and be amenable to fast drying to save energy costs. The next generation of probiotics will include strict anaerobic microbes, which are prevalent in the gut microbiome (where there is little or no oxygen), but their use has been limited so far because of their sensitivity to oxygen. Companies are working hard to bring these probiotics to the market.

What is the legal status of probiotics?

The commercial classification of these products varies according to the regulatory status in each country. The same product can be sold as a drug or medical device in some countries, or as a food supplement in others. Europe has the strictest regulations on health claims which has resulted in an effective ban on the term ‘probiotic’, except in Italy and Switzerland.

Despite this, Europe is still the global leader in the probiotic industry. This is due to a history of Europeans consuming fermented foods and probiotic supplements for gut health, and an interest in using such methods to balance skin, vaginal and oral microbiomes too, as alternatives to chemical compounds.

Probiotics that are sold with health claims have to go through the same process of pharmaceutical evaluation as drugs, medical devices or novel foods, with pre-clinical and clinical trials. However, in contrast to drugs, probiotics are live organisms that should colonise our bodies. The difficulty of monitoring, in real-time and with high specificity, the changes in microbial communities and their interactions with the human immune system is the crucial challenge to understanding the mechanisms by which probiotics act in our bodies. Even if a definite beneficial effect is demonstrated, there are still countless varieties of interactions between microbiome and host, about which very little is known.

Probiotics are commonly used in animal nutrition, in fermented silage and as food supplements. Their application in animal feed is legally recognised in Europe and encouraged as a sustainable innovation. There is a Europe-wide regulatory framework and a well defined process for safety assessment of new products.

Is probiotics a sustainable industry?

The probiotics industry is highly sustainable because it is based on biological raw materials and has only biological recyclable waste products. Microbes can be grown on side products of the food industry, minimising waste, or even directly in foods to extend their shelf life (such as yoghurt).

However, the most important sustainable impact of the probiotics industry is in its potential to replace hazardous and persistent chemicals such as antibiotics, dramatically improving the sustainability of livestock farming. Similar benefits can be seen in the food industry, improving health and nutrition in consumers with very low carbon footprint bioprocesses. For these reasons, the World Economic Forum in Davos recognised the industry as being in step with the UN Global Goals and ranked a European probiotic company as the world’s most sustainable industry.