Quality criteria – 25 years of quality we are proud of
Austria’s leading centre of excellence in the field of microbiome research applies the following quality criteria in the manufacturing of its products
Cooperation with European university hospitals
Institut Allergosan always works at the cutting edge of science and integrates global medical and pharmaceutical research findings into its product development. Due to the many years of close cooperation with a wide range of European university hospitals, we have succeeded in launching innovative products which are clinically convincing and whose safety and effectiveness have been proven.
Clinical studies – internationally recognised and prize-winning
The use of medically relevant probiotics in the treatment of diarrhoea associated with antibiotics is one of the most tried and tested applications of probiotic bacteria. Due to a major publication in the American Journal of Gastroenterology in 2008, which was chosen as one of the twelve best and most relevant studies in the field of microbiome research by the World Gastroenterology Organisation (WGO), a broad medical audience became aware of Institut Allergosan’s products.
Considerable interest was also created by our studies showing that the use of probiotics during pregnancy and for newborn babies can enable the immune system to be changed in such a way that allergenic conditions and neurodermatitis do not occur (the PANDA study published in the journal ALLERGY).
Since then, the studies carried out by Institut Allergosan have been well-received internationally, a fact which is shown by their inclusion in worldwide meta-analyses (Cochrane Library) and by citations in the leading medical journals.
Leading in microbiome research
In particular, Institut Allergosan has made a name for itself internationally in research on the entirety of the microorganisms found in the human body. Thanks to a multitude of research projects in this field, there is a lively exchange of information between the Institute’s staff and research units in many countries and at many universities.
Institut Allergosan’s reputation is especially evident in the fact that it participates in a total of four studies in one of the largest nationwide Austrian research projects, CBmed. This project deals with the possibility of discovering biomarkers for illnesses, and the participation of Institut Allergosan with its synbiotics is seen as a great opportunity to make an important contribution, especially in the fields of diabetes and obesity, the occurrence of septicaemia, the treatment of NASH (non-alcoholic liver diseases) and brain-related illnesses.
Unique formulas and optimal packaging
Formulas which are developed while taking holistic physiological and medical aspects into consideration are often unique. Alongside our internationally respected expertise in such aspects as bioavailability, the highest level of activity and the ability to reproduce in the human gut, we also place great emphasis on product transport and packaging in order to – for example – guarantee the stability of microorganisms also at higher temperatures. In addition, our synbiotics are deliberately packed in sachets in order to have an ideal moisture-stable environment. This enables the bacterial helpers in them to not only rehydrate themselves outside the body in an optimal way, but also to activate them with a special matrix so that they are given maximum resistance to accompany them on their journey into the bowels.
Innovations and world firsts
The tremendous team spirit of all the staff at Institut Allergosan is sustained by our pride in the international recognition we receive, but also by the positive feedback we receive on a daily basis from our customers, and the trust and gratitude which they express.
With product developments which are deployed for a wide range of conditions such as depression, diabetes and obesity, or for seriously ill people with cirrhosis of the liver (OMNi-BiOTiC® HETOX), the Institute has also caused a major change in thinking in Austrian hospitals. Many of these hospitals have regularly used OMNi-BiOTiC for their patients since the studies on our new indication-specific synbiotics caused a stir worldwide.
Bioavailability is particularly important to us for two reasons. Firstly, of course, in the sense that the ingredients used in our products need to be highly bioavailable. But also because only a healthy gut is able to actually take in vital substances from food and to make use of them.
The highest quality raw materials
Institut Allergosan cooperates with the most reputable raw materials producers worldwide. Purity, bioavailability, standardised lead compounds, sustainability and scientific documentation are the selection criteria we apply to the raw materials which we use in our products.
Tested and safe
The strains of bacteria used for OMNi-BiOTiC® products have been identified and categorised according to the highest technological standards by the independent organisation NIZO Food Research based in Amsterdam.
In addition, all of the strains of bacteria used in OMNi-BiOTiC® are stored in a safe deposit of the DSMZ (German Collection of Microorganisms and Cell Cultures), and are examined on an ongoing basis to ensure that they do not exhibit any genetic changes.
The European Food Safety Authority (EFSA) has, via the introduction of the QPS status (Qualified Presumption of Safety), created the opportunity for all strains of bacteria used in Europe to obtain a safety certificate which proves that these strains have, for at least 30 years, not posed a safety risk for use in humans. All of the strains used in OMNi-BiOTiC® have such safety dossiers which are recognised by the EFSA.
In addition, all the strains of bacteria used in OMNi-BiOTiC® are also tested by independent research institutes as to whether they can cause resistance to antibiotics. An essential aspect for the safe use of bacteria is that they are sensitive to antibiotics, so that they also cannot develop any antibiotic resistance in the future.
Good manufacturing practice (GMP) as the basis for production
Quality assurance plays an essential role in pharmaceutical manufacturing. Deviations in terms of quality can have direct effects on the health of the user, which is why a quality management system in line with GMP serves to guarantee product quality and the fulfilment of the binding requirements set by health authorities for their marketing. We therefore view good manufacturing practice (GMP) as an important guideline for the quality assurance of the production processes and environment in the manufacturing of all of Institut Allergosan’s products.
Suitable for diabetics
Due to the practically non-existent amount of sugar they contain, all of our products are suitable for diabetics. Very precise labelling of the relevant carbohydrate amounts on the packaging provide information on whether, for example, fructose is contained in tiny amounts in case we require this substance to activate a strain of bacteria.
Consumer-friendly full declaration of ingredients
If you buy a product from Institut Allergosan, you have a right to be fully informed about the ingredients. Particularly when it is about your own health, you want to know what you are taking. For this reason we list the exact amount of every ingredient. And if you look closely, you can recognise that optimally dosed product formulas really make a difference.
A team of experts
A team of experts from the fields of medicine, pharmacology, biology, nutrition, physiology and microbiology is working every day for you here to develop new products, to further improve existing ones and to provide you with help and advice if you need it. This point in particular is of a great importance to the owners of Institut Allergosan.
Sustainability and fairness
In order to ensure that sustainability and fairness are more than just words, Institut Allergosan is actively involved in many social projects. For example, growing organic papayas for our product CARICOL® was initiated via a development aid project in Sri Lanka. These organic papayas – and now also the production of Caricol – have given people living there, and particularly women whose entire possessions were stolen during the civil war, the opportunity to obtain their own land again and to make a living.
The quality criteria for medically relevant pro- and synbiotics
The following quality criteria were taken from the guidelines of the World Health Organisation (WHO), the US Food and Drug Administration (FDA), the World Gastroenterology Organisation and the Austrian/German Societies for Probiotic Medicine (OePROM / DePROM).
1. Number of bacteria
At least 109 KBE (= 1 billion bacteria per gramme of powder). This means that a relevant number of viable bacteria can be ingested.
2. Multi-species formula of symbiotic strains of bacteria
The combination of different strains of bacteria enables an improved synthesis between bacteria and human cells as well as a multiplication of the potential of the individual strains: a team with a range of skills is better than one lone fighter.
Probiotic bacteria are most effective in the 24 hours after they have been rehydrated, when they become active again. In yoghurt this process takes place in the dairy, where the yoghurt is created by producing lactic acid from milk, whereas in powder granulates it occurs in our bodies, where the bacteria actively do their work for us.
4. Reproductive rate
Proven reproduction of probiotic bacteria also after the end of therapy. Evidence of this has only been obtained for very few products until now, as only very high reproduction figures can be recorded. Evidence of this kind for OMNi-BiOTiC® PANDA and OMNi-BiOTiC® 10 AAD has also been published in scientific journals.
5. Stability at room temperature
The number of bacteria at the end of the best before date should be given, not the number of bacteria at the time of packaging. This is because many bacteria already die after a few days if the environment does not offer ideal conditions for their survival. Upon request, a quality analysis of every batch of OMNi-BiOTiC® products can be provided including evidence of stability at room temperature for 24 months.
6. Resistance to stomach and bile acid
The resistance of the bacteria to strong acids is an essential aspect. The revitalisation of the freeze-dried bacteria should ideally take place outside the body in a neutral liquid. There, the bacteria can ingest their first food and gain strength before they have to embark on a passage lasting hours through the stomach with its acid and through the duodenum with bile acid and pancreatic juice.
7. Optimisation of the milieu
The ideal pH value in the small intestine is 4.0-5.0. Beneficial bacteria reproduce optimally at this value, whereas pathogens do not.
8. Fast rehydration
Bacteria are instable during their ‘reawakening phase’. They only start to become active when they have received food and have become accustomed to their environment. In capsules, this process is delayed considerably.
9. Synergy of different strains of bacteria
Not all strains of bacteria harmonise with each other – on the contrary, they can become competitors (e.g. for food). The efficiency of combined bacteria products therefore needs to be proven by a so-called cross streak method, and/or there should be studies available on their effectiveness.
All of the strains of bacteria used should have obtained international GRAS (Generally recognised as safe) status, which ensures the highest level of safety for ingestion by humans and the absence of side effects, also when taken over a longer period.
11. Free of sugar, gluten and animal proteins
To avoid promoting existing intolerances.
In order to increase the activity and reproductive rate of bacteria, enzymes, fibre and minerals are added. This increases the mucus production of the intestinal lining and the adhesion of the bacteria combination which has been ingested.
OMNi-BiOTiC® products comply with these quality criteria and consist solely of bacteria cultures which are found in humans and are capable of reproduction.
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