VP, Strategic Business Management, Hovione

Márcio Temtem

Márcio Temtem, Hovione, discusses how to tackle pharma complexity via regional growth in the US, Ireland, and Portugal, using digital tools to accelerate development.

Navigating the New Reality of Pharma Manufacturing

Márcio Temtem, vice president, Strategic Business Management, Hovione, discusses the evolving landscape of the pharmaceutical industry, in which many firms are learning to navigate a new reality characterized by increased speed, complexity, and a significant shift toward regional supply chains over global ones. To address these challenges, Temtem emphasizes Hovione's commitment to providing an integrated offer that spans the entire production process. Temtem notes, "we keep committed in serving our clients with an integrated offer that covers from drug substance to drug product."

A central theme of the discussion is Hovione’s strategic investment across its four sites located in three continents. In the United States, the company recently completed a $100 million investment to bolster capacity in particle design and amorphous solid dispersions via spray drying, as well as batch and continuous tableting. In Ireland, Hovione is doubling its spray drying capacity to address the solubility enhancement needs of increasingly complex new molecules. Temtem also highlights a greenfield expansion in Portugal, which is intended to help the company respond to diverse client needs across various market segments.

Beyond physical infrastructure, Temtem stresses that innovation is driven by the synergy between physical assets and advanced science. When it comes to their new investments and expansions in their services, he states, "We take this integration not just on the perspective of the assets, but also on the perspective of the science that we do." To accelerate the CMC development section, Hovione is incorporating digital tools, such as modeling, big data, and process analytics into its operations. Additionally, the company is advancing manufacturing technology through partnerships, such as the development of the ConsiGma platform with GEA. This holistic approach positions the company to meet the modern demands of the Western pharmaceutical market, says Temtem.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

In our case, as I said before, industry is facing a new reality in terms of speed, in terms of complexity, and in terms also of supply chain. Much more regional today, less global than in the past. In our case, we keep committed in serving our clients with an integrated offer that covers from drug substance to drug product. And that also reflects in an increased investment across these regions. As I said before, Hovione is positioned in three continents with four different sites. In the US, we have recently announced an investment of the completion of the investment of one hundred million, that will strengthen our capacity in particle design or in amorphous solid dispersions by spray drying, as well as in the drug product arena, batch tableting and continuous tableting. In Ireland, we are doubling our capacity in spray drying, most related with this need that I mentioned before, with amorphous solid dispersions, and the need to address some of the complexity of the new molecules and the complexity with solubility enhancement. And in Portugal, the same thing. We are expanding to a new greenfield, something very rare, I would say, these days in the Western world. We believe that with this new investment, we will be able to respond to our client needs in the different segments that we operate today. So we take this integration not just on the perspective of the assets, but also on the perspective of the science that we do. We are also trying to add new tools to our toolbox, to accelerate development. And within those tools, you include modeling, big data, process analytical tools, and others that enable, to accelerate the CMC section development. And some of those tools I also mentioned before, also on the manufacturing side of things, like the development of new ways of manufacturing, such as the ConsiGma, with the partnership that we have with GEA.

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Márcio Temtem, Hovione, discusses how his company integrates modular hardware and modeling software to accelerate pharmaceutical R&D and optimize manufacturing processes.

Accelerating Pharma R&D with Modular Hardware Solutions 

Márcio Temtem, vice president, Strategic Business Management, Hovione, is addressing the evolving landscape of pharmaceutical R&D by focusing on synergies between hardware and software innovation. Temtem observes that the current industry climate is defined by a permanent shift toward speed and intricacy, stating, "on the increased complexity acceleration, I think they are here to last.”

To meet these demands, Hovione has focused on hardware modularity and flexibility through strategic partnerships. Of significance is the collaboration with GEA to produce the ConsiGma® CDC Flex, an innovative technology that combines three equipment functions. This hardware allows for batch tableting alongside both low-and high-throughput continuous tableting, enabling developers to create processes at a faster pace with minimal API usage.

Additionally, Hovione is in a partnership with Microinnova, a collaboration that facilitates modular continuous flow setups. Regarding the strategy behind this, Temtem notes, "The idea is that the chemists should, from early stages of development, start thinking on the setup that will be later used in commercial manufacturing."

Beyond hardware, Temtem emphasizes the role of software and modeling in expediting the CMC section development. He highlights that Hovione has developed an arsenal of modeling tools developed to accelerate formulation screening and process development for platforms such as amorphous solid dispersions. These modeling techniques are also being applied to continuous tableting to ensure a more efficient transition from development to production. By integrating these advanced hardware solutions with sophisticated software modeling, Hovione aims to provide a more flexible and responsive framework for modern pharmaceutical manufacturing.

Some of the trends that I mentioned before, on the increased complexity acceleration, I think they are here to last, right? Our R&D continues to focus in the in the development of new hardware and new software. I think it came recently to public, very good examples of what I mean by newer hardware or the new software. On the hardware part, we have recently signed a partnership with GEA, one of the main suppliers of continuous tableting for pharma. And as part of this partnership, we have recently launched together, a new way of making tablets, a new ConsiGma® CDC Flex, which is a disruptive offer into the market. In one single press, in one single unit, you have three pieces of equipment. You have the opportunity to do batch tableting, at the same time that you have the opportunity to do, continuous batch tableting with very low throughputs or very high throughputs. So the unit has been designed with this modularity, with this flexibility, to address some of the challenges that I mentioned before on acceleration. Some of the challenges related with being able to develop processes with minimum use of API and at a much faster pace. On another example also, in the hardware, we have also recently signed a partnership with a with a company called Microinnova for the development of modular setups on continuous flow. The chemists, the idea is that the chemists should, from early stages of development, start thinking on the setup that will be later used in commercial manufacturing. And this is one of the companies that is offering these packages that allow to reach such a goal. It's not just about hardware, it's also about software, as I said before. And on the software side, we have also been exploring, for instance, new ways of doing chemistry. Miscible chemistry is a very good example of that, or new ways of expediting the CMC section development through modeling. On the modeling side, I think a very good example of that relates with the tools, with the toolbox that Hovione has developed over these years, and continuously developed to accelerate formulation screening and process development with platforms such as the ones that I mentioned before on the amorphous solids dispersions. And it's something that we are currently mimicking in other areas, such as the continuous tableting that I mentioned before.

Márcio Temtem

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