Our Manufacturing Innovations

For probiotics to be effective and offer health benefits, they must remain viable throughout delivery. This requires the probiotic cells to survive both the manufacturing process and the shelf-life conditions of the final product. Additionally, they must endure passage through the digestive tract to the intended site of intestinal delivery. Typically, only 20% of traditional, uncoated cells survive through the the small intestine.

 We've created a microencapsulation technology that envelops probiotic cells in a food-grade, lipidic vegetable matrix. This enhances the durability and survivability of the probiotics. Our patented technology ensures that these microencapsulated strains are stable throughout shelf life and safely navigate the stomach's acidic environment, reaching the intestinal tract intact to proliferate and perform their biological functions.

Although the efficacy of probiotics is well-documented for many health applications, probiotic products can pose a risk to individuals with moderate to severe food allergies, as well as to infants and children whose allergy profiles are still unknown. This is because probiotic products can trigger allergic reactions due to the presence of allergens in the manufacturing process. In fact, studies have shown that roughly 70% of probiotic products on the European market contain milk or its derivatives.

We've pioneered an innovative, internationally patented manufacturing process (EP 1 869 161 B1 - WO/2007/054989) to create allergen-free probiotics. Our probiotics are free from all potential allergens listed in both Annex II of Regulation EU n. 1169/2011 and relevant U.S. regulations. This is achieved by avoiding the use of any potential allergens throughout the probiotic manufacturing process and the final dosage forms. Each of our 'Allergen-free' batches is certified by our internal Quality System, which monitors for possible cross-contamination, ensuring a safe formulation even for those with food allergies or intolerances.

Infants and individuals with swallowing or chewing difficulties require a liquid formulation that delivers the necessary daily amount of probiotic bacteria in just a few drops, typically 5-10. An oil suspension is the ideal dosage form for these patients, as a non-aqueous matrix is essential; live bacteria deteriorate quickly in water-based solutions. However, most oil suspensions on the market are low quality and negatively impact the viability of the suspended probiotics.

We've created an oil suspension that preserves microbial efficacy throughout its entire shelf life. This is achieved by selecting a vegan vegetable oil blend (corn oil and/or sunflower oil) free from toxic factors, and by safeguarding the probiotic strains from oxidation through our patented microencapsulation technology, which uses a special food-grade lipid vegetable coating matrix. This stable liquid format is ideal for delivery of probiotics to babies and patients with swallowing difficulties.

The probiotics industry faces a significant challenge in bacterial enumeration, a crucial factor for product quality and efficacy. Traditional Plate Count (PC) methods with a Colony Forming Unit (CFU) quantification, although widely used, have limitations in speed, accuracy, and applicability to diverse bacterial strains. These shortcomings are especially problematic given the complex nature of probiotics and the growing inclusion of non-culturable and heat-killed strains.

Probiotical is pioneering the use of Flow Cytometry, a state-of-the-art enumeration technology that addresses these challenges head-on. This advanced method allows for rapid, accurate, and comprehensive bacterial counting, including the detection of Viable But Not Culturable (VBNC) cells. By implementing Flow Cytometry, Probiotical is setting new industry standards, ensuring that their products meet the highest criteria for quality and efficacy.