Periodic Reporting for period 2 - BioAXOS (A novel cost-efficient process to produce best-in-class prebiotics from side-products of the bioethanol industry)
Okres sprawozdawczy: 2019-04-01 do 2020-03-31
Pure Fiber Ltd is an Irish-based ingredient company established in 2016 to commercialise innovative dietary fibre processing technologies. The production partner of Pure Fiber is Pannonia Bio Kft, Europe’s largest and newest ethanol production facility located in Hungary. Pannonia Ethanol is GMP+ Feed Safety Assurance Scheme certified.
The mission of the Pure Fiber project BioAXOS is to bring to market highly effective and affordable prebiotic soluble fiber ingredients for pet food, human food and nutraceutical applications.
Interest in gut health, the microbiome and probiotics is growing quickly as medical scientists learn about the essential role of the microbiome in many aspects of the health of people and animals. The microbiome is now recognised as a vital organ in its own right. Probiotics are microorganisms that can be delivered to the gut to provide health benefits. Prebiotics are substances which promote the growth of these beneficial intestinal microorganisms. They are the materials which cannot be digested by the gut itself but can be digested by the microorganisms which live in the gut, to provide energy, vitamins and neuroactive substances.
Modern diets, whether in humans or domesticated animals, are deficient in prebiotics, possibly excessively deficient. A wide range of medical conditions are suspected to be connected to the deficiency, including leaky gut, irritable bowel syndrome, autoimmune diseases, acid reflux, obesity, mental health issues and skin disorders. Medical scientists and nutritionists are increasingly seeking ways to add prebiotics back into modern diets. The potential for therapy and prevention is enormous.
In addition to the potential health benefits of the Pure Fiber prebiotics, the products will exhibit complementary benefits for the food processing sector, as an emulsifier, stabiliser and thickener.
BioAXOS will bring to the market a form of corn-derived arabinoxylan dietary fiber that is known to gut health experts for its prebiotic potential but which has not been commercially available.
The mission of the Pure Fiber project BioAXOS is to bring to market highly effective and affordable prebiotic soluble fiber ingredients for pet food, human food and nutraceutical applications.
Interest in gut health, the microbiome and probiotics is growing quickly as medical scientists learn about the essential role of the microbiome in many aspects of the health of people and animals. The microbiome is now recognised as a vital organ in its own right. Probiotics are microorganisms that can be delivered to the gut to provide health benefits. Prebiotics are substances which promote the growth of these beneficial intestinal microorganisms. They are the materials which cannot be digested by the gut itself but can be digested by the microorganisms which live in the gut, to provide energy, vitamins and neuroactive substances.
Modern diets, whether in humans or domesticated animals, are deficient in prebiotics, possibly excessively deficient. A wide range of medical conditions are suspected to be connected to the deficiency, including leaky gut, irritable bowel syndrome, autoimmune diseases, acid reflux, obesity, mental health issues and skin disorders. Medical scientists and nutritionists are increasingly seeking ways to add prebiotics back into modern diets. The potential for therapy and prevention is enormous.
In addition to the potential health benefits of the Pure Fiber prebiotics, the products will exhibit complementary benefits for the food processing sector, as an emulsifier, stabiliser and thickener.
BioAXOS will bring to the market a form of corn-derived arabinoxylan dietary fiber that is known to gut health experts for its prebiotic potential but which has not been commercially available.
In the course of the 24 months of BioAXOS, extensive production engineering work was conducted, pre-commercial regulatory actions and clinical trials preparations were carried out and preliminary product and market development partnerships were established.
In the area of production engineering, multiple pilot plant batches were produced, analysed and used for fine tuning the process design. Laboratory resources were upgraded, to enable the carrying out of analysis in house, thereby shortening turn-around times for reporting on batch outputs, and enabling consistency of analysis methods.
Regarding regulatory pathways for dietary fiber in EU and USA markets, and in human and animal sectors, a comprehensive analysis of the regulatory contexts was conducted and numerous experts in the area were consulted. The team continues to monitor developments in the regulatory landscape. Final dossiers for regulatory actions will be completed in parallel with completion of the production process, as the product characteristics are in part dependent on the process.
Preliminary work was carried out to establish the best strategy for clinical trials execution.
In depth product and market analysis was performed to create a comprehensive map of comparable dietary fibres (products, characteristics, producers, volumes, pricing, marketing strategies), enabling Pure Fiber position its offerings in an optimal way.
The project team held multiple meetings with experts in the fields of prebiotic research and food manufacturing, with the dual aims of researching the sector and establishing relationships for potential future collaborations.
The team participated in a number of important research and business oriented conferences and trade fairs.
In the latter half of the period all of the key unit operations of the production process were enhanced, improvements were made for odour and appearance, food product ingredient trials were conducted for a number of product types, and certain prebiotic efficacy tests were carried out.
In the area of production engineering, multiple pilot plant batches were produced, analysed and used for fine tuning the process design. Laboratory resources were upgraded, to enable the carrying out of analysis in house, thereby shortening turn-around times for reporting on batch outputs, and enabling consistency of analysis methods.
Regarding regulatory pathways for dietary fiber in EU and USA markets, and in human and animal sectors, a comprehensive analysis of the regulatory contexts was conducted and numerous experts in the area were consulted. The team continues to monitor developments in the regulatory landscape. Final dossiers for regulatory actions will be completed in parallel with completion of the production process, as the product characteristics are in part dependent on the process.
Preliminary work was carried out to establish the best strategy for clinical trials execution.
In depth product and market analysis was performed to create a comprehensive map of comparable dietary fibres (products, characteristics, producers, volumes, pricing, marketing strategies), enabling Pure Fiber position its offerings in an optimal way.
The project team held multiple meetings with experts in the fields of prebiotic research and food manufacturing, with the dual aims of researching the sector and establishing relationships for potential future collaborations.
The team participated in a number of important research and business oriented conferences and trade fairs.
In the latter half of the period all of the key unit operations of the production process were enhanced, improvements were made for odour and appearance, food product ingredient trials were conducted for a number of product types, and certain prebiotic efficacy tests were carried out.
BioAXOS will result in a new range of quality prebiotics being available on the market at volumes and at a price consistent with large scale application and consequent impact on the quality of human and animal diets. The aim is to be producing several thousand tonnes of prebiotic per year, provide dozens of quality jobs and increase the value of Europe's grain based biorefineries.