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.

Transcript:

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.

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.