Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services and process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. Exothera is part of Univercells, a global life sciences leader with the mission of “making biologics accessible to all”.
Thank you for joining us today Hanna. Could you please introduce yourself and your role at Exothera?
Of course. I am Hanna Lesch, the Chief Technology Officer at Exothera. I’m responsible for the company’s technology development & innovation. I also support our business development and marketing teams.
What challenges are you experiencing in vaccine manufacturing?
There are several challenges we encounter in viral vector manufacturing. Firstly, the complexity of the product and the manufacturing process themselves pose significant challenges. Moreover, the high cost associated with manufacturing is a key concern. Additionally, navigating the complex legislative landscape surrounding Advanced Therapy Medicinal Products (ATMP) and ensuring patient access to these therapies is another obstacle. And lastly, determining who bears the reimbursement of these costly therapies is an ongoing issue. As professionals in this field, there is still work for us to address these challenges because we need to make biologics available for all.
Can you tell us about the exoReady platform?
When many developers and clients approach us, they want to have a fast solution to their product to make them ready for the clinic as fast as possible. So, they are looking for ready-to-go solutions and that is what exoReady can provide for our clients: manufacturing technology solutions for Lenti, Adeno and AAV.
How do the scale-X bioreactor and Nevoline™ upstream platform answer your needs?
Quite well. We have extensively utilized the scale-X™ technology and NevoLine™ platform, incorporating fixed-bed solutions, for various products, including vaccines and vectors, as well as diverse cell types. The scalability and flexibility of this technology have allowed us to grow cells efficiently and perform both transfection-based and infection-based processes. We have successfully employed mammalian cells, insect cells, avian cells, and stable cell lines. Overall, it has proven to be very versatile tool for our manufacturing processes.
What are you looking for when selecting a manufacturing technology? What criteria determine your customer choice?
When choosing a manufacturing technology, we primarily rely on our scale-X fixed-bed bioreactors, which offer solutions ranging from small to large scale. This scalability is particularly advantageous for adherent cells. We also take advantage of scale-X bioreactor’s ability to work with suspension cells, which allows for innovation in our processes.
The NevoLine platform enables cost-effective manufacturing by supporting high cell densities within a compact system, thereby reducing the cost per dose. From a CDMO’s perspective, the low footprint of the NevoLine platform further contributes to cost reduction in our operations.
Hanna Lesch, CTO – Exothera
What makes our technology stand out from the others?
While every system has its pros and cons, the scale-X system offers several key benefits. The scalability and reduced footprint are the most important factors about scale-X technology. Furthermore, the continuous mode operation and perfusion capabilities are particularly appealing. So, basically, there is no need for additional perfusion system. You can just pump medium in and out without any additional filters.
If you have a lysis-based process, chemical lysis is quite efficient. And when you are harvesting your product, a lot of cell debris stays there in the fixed bed. So, it’s a good starting point for the downstream processes. And if we think of midstream processing, the NevoLine platform is integrated with clarification filters and Tangential Flow Filtration (TFF), meaning that it further reduces the system’s footprint.
What’s the main reason you would recommend the NevoLine platform to your customers?
The NevoLine platform offers several compelling features. Firstly, it provides scalability suitable from clinical trials to commercial-scale production. Additionally, it enables cost-effective manufacturing by supporting high cell densities within a compact system, thereby reducing the cost per dose. From a CDMO’s perspective, the low footprint of the NevoLine platform further contributes to cost reduction in our operations.