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A resource-efficient granulation process for advanced formulation of any compound in food and pharma production

Periodic Reporting for period 1 - AGS (A resource-efficient granulation process for advanced formulation of any compound in food and pharma production)

Reporting period: 2015-12-01 to 2016-03-31

AGS project aims to introduce a ground-breaking granulation process to produce any nutraceutical compound. The expected outcome of the project is a scaled-up and GMP complient nutraceutical processing machine that has been tested with dozens of nutraceuticals and CE certified. The machine will have the capacity to produce up to 120 kg/h high bioavailability nutraceutical granules. The final outcome of the project is to start the full commercialization of AGS in Europe. This will require specific upgrades of the AGS existing system, including the geometry optimization, study and test the effect of different type of gasses, and design and develop in-line sensor system to check and validate the process dynamics and outputs (density, moisture, shape and size).
The Phase 1 Feasibility Study has allowed Polibiotech to enhance their knowledge of the existing technologies and competition, assess the nutraceutical market size, customer segments, the existing nutraceuticals regulations and standards, as well as to establish the sound industralisation plan. The Phase 1 Feasibility Study showed, that in order to commercialise AGS, its capacity must be increased. And this will require some geometry optimizations, such as a new compactor and new a fraction device. In order to comply with the GMP standards Polibiotech must enhance the machine with in-line sensors system to check and validate the process dynamics and outputs have to trace how the material flows through the system.
The Feasibility Study showed that the AGS technology with its competitive advantages, puts Polibiotech in a strong position as the current granulation machines have a long new product R&D time (an average 4 months), very high production costs (due to high electricity usage, material waste and water usage) and NO possibility to renew the expiring patents. It is crucial that Polibiotech advances its current technology and commercial readiness levels to experience significant growth and development in the following years. A successful demonstration with a wide range nutraceuticals will help overcome the concerns about the continuous granulation systems.
The Feasibility Study also showed that the AGS machine will have a rapid market penetration and will reach a BEP in the first year. But to achieve Polibiotech desired goal and become a leader of the continues granulation system for nutraceutical, food and pharmaceutical, the technology must be optimised for reductions in costs of materials, efficiency and flowability.
Polibiotech aims to introduce Aerodynamic Granulation System (AGS) to the nutraceutical market, able to process any food or drug compound and to produce a high bioavailability products. AGS has the potential to have a significant impact within the EU and worldwide contributing to better quality of life of the population in terms of health preventions. Healthcare represents 8% of the total European workforce and contributes to an average 10% of the EU’s GDP. Through the development of AGS and the general improvement in nutraceutical availability, there could be a rise in employability and a reduction in productivity losses; ill-health currently causes a yearly cost of about 2.5% of GDP through absenteeism. The advances in technology will bring nutraceuticals to market in a more efficient timescale and produce formulations of nutraceuticals from all APIs discovered, thus resulting in a wider range of products and the ability to prevent more diseases/ailments etc. Environmentally, AGS is a more sustainable nutraceutical formulation system and the Directive 2008/98/EC defines the basic waste management principles; hazardous wastes present a greater risk to the environment and human health and thus require stricter controls.
The AGS Pilot Plant, located at the Pharmaceutical Technology Dept of the Helsinki University (Finla
The AGS Plat in Helsinki