| Category: Success stories

Novo Granules provides new pharmaceutical manufacturing solutions

Novo Granules is a company focused on dry granulation. The company is registered in Kuopio and was established in 2024. However, the company’s origin story traces back to AGS Finland Ltd established in 2010 and a long background in research. Arto Lahti, Giovanni Politi and Antti Kivimaa are involved in running Novo Granules. Kivimaa is the Chair of the Board and the company’s spokesperson, Lahti is responsible for international initiatives and Politi is the inventor of the method and a researcher in pharmaceutics with a long research career. The company’s name comes from Latin and has the literal meaning of ‘new granules’. While the company is currently purely a start-up, it aims to obtain the necessary funding in the spring of 2024 and get the company’s operations up and going.

”The AGS (Aerodynamic Granulation System) technology of Novo Granules is a patented world-class method that enables the dry granulation of practically any substances in powder form (chemical-pharmaceutical-natural products). As a rule, AGS is intended for the purposes of the pharmaceutical industry but also has potential applications in the chemical and food industries. AGS allows always achieving granulation regardless of how fine the particles contained by the granulated powder are, which means that it can also be used for the granulation of nanoparticles.

AGS experimental facility, at the Department of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki. (Photo: aggrade.co.uk, 2024)

Development collaboration with the university

“Although the system has existed for a longer time, there was a delay in verifying that it works due to issues such as the COVID pandemic. We noted that the best solution involved launching measures to develop the technology in collaboration with the university, as they have the required expertise and research in the field. When it comes to medicine manufacturing technology and especially the AGS method, Kuopio has absolute top expertise, and we were able to get Professors Jarkko Ketolainen and Ossi Korhonen from the School of Pharmacy involved in our efforts”, Lahti explains.

“Ketolainen is the Head of Department and has a strong background in processes related to the manufacturing of pharmaceuticals. Korhonen is a Professor in Pharmaceutical Technology and his research areas include amorphic formulations and continuous manufacturing of pharmaceuticals. They were also the ones who informed us about the existence of Kuopio Health, and as the cooperation with the health ecosystem was a logical step for us, we contacted Development Manager Kimmo Solehmainen. We’ve found that alliances like this enable finding the best solutions and making quicker progress. We believe that this cooperation between top experts will allow us to develop Novo Granules optimally”, Lahti and Kivimaa note.

Lahti explains that Kuopio’s strengths lie in top expertise in the field of pharmaceutical manufacturing technology and Finland’s biggest school of pharmacy at the University of Eastern Finland. The University has a strong foundation in science but it is also a major operational player. The expertise we have here in Kuopio covers the entire industrial manufacturing process of medications, from pharmaceutical agents to pharmacies as well as production and storage perspectives. Kuopio also has a key role in comprehensive safety and has an optimal location from a distribution viewpoint. The manufacturing of pharmaceuticals in our country also strengthens Finland’s security of supply, a topic of much discussion in recent years.

Speed and efficiency as advantages of dry granulation

“There is a lot of research and effort behind this method, and a lot of work went into getting the patent. Applying the methods of physics in the manufacturing of pharmaceuticals is new, and how various particles behave in air and gas currents is relevant, for instance.  It is often considered that drug development only revolves around chemistry, but it may also involve how different medications are absorbed. In the past, it has been extremely difficult to process nano-sized particles, whereas the AGS technology allows efficient processing of any powdered substances. This makes manufacturing in the pharmaceutical industry remarkably stable. This method has also been approved by the FDA (US Food and Drug Administration) and it has the potential for medicine manufacturing at the global level.

“AGS enables considerably high efficiency in generic drug manufacturing. As a result, due to aspects such as costs between manufacturing countries, the drugs can be manufactured anywhere in the world as the differences in costs are minor. This expands the group of industrially manufactured medications, as the dry method allows producing drugs that it would be technically difficult or even impossible to achieve using a wet method”, Lahti adds.

“This method enables producing the majority of traditional medications more affordably, with smaller investments and more ecologically, and it also consumes less energy. The AGS method considerably increases the speed of the drug development process as it allows you to quickly examine large amounts of different pharmaceutical agents. With traditional methods, the testing required to produce the right products took a long time, whereas this technology allows you to increase the speed of the process. Our aim is not to produce new molecules but, instead, to use this method to improve old molecules in terms of aspects such as their storage life and effectiveness. Another important factor is that this allows cutting the costs of drug manufacturing by dozens of percentages”, Lahti and Kivimaa explain.

Goal: a world-class centre of excellence in Kuopio

“In developing countries, where counterfeit medications are a major problem, the AGS method allows local production that is remotely monitored from Kuopio. While the use of the method requires training on the process, the aim is that after the training, countries can produce their own medications. To create a product that can be distributed worldwide, we need a centre of excellence in Kuopio where research and testing can take place”, Lahti says.

Novo Granules aims to take gradual steps towards an operational testing centre for AGS technology and commercial research activities, and the university plays a key role in this process. The aim is to join the Aerodynamic Granulation System and a few measurement devices to laboratory equipment already available at the university. The university can also develop new drug formulations and provide training on the method.

“To utilise this technology globally, we aim to make the AGS method licensable. We can also create a precalibrated version of the AGS that can be transported to any pharmaceutical factory in the world. It will be easier to obtain marketing authorisation for new products when the AGS produces stable results and when its processing does not affect the chemical properties of granulated substances. A patent bound to the manufacturing method also enables patent production for old and generic products”, Lahti, Kivimaa and Politi say, describing the prospects of their company.

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