2024-10-24

Q: How is Exothera adapting its services to accommodate the growing demand for RNA-based therapeutics?

Cédric Volanti: Exothera has a standardized, robust, and reproducible process for manufacturing mRNA. We apply the same process through scale allow fast track for large-scale manufacturing. Thanks to our collaboration with Quantoom Biosciences, an automated large-scale production unit is available to manufacture large quantities of cGMP mRNA in a timely manner. Exothera is also developing state-of-the-art analytical methods that can be used for product characterization and release. 

More recently, we developed a specific offering for personalized cancer vaccines that addresses the challenges of this medicine breakthrough by significantly reducing patient time and cost of treatment. 

Q: Can you explain how Exothera's Scale-X and iCellis bioreactors optimize viral vector production?

Cédric Volanti: As a CDMO, Exothera is offering multiple production platforms to fit our customer needs. Viral Vector or Vaccine production optimization is key to ensuring product quality, batch-to-batch reproducibility, and decreased COGS. Our process development team focuses on optimizing the key parameters for upstream and downstream process steps. Our long-lasting experience with adherent cell culture and the Scale-X bioreactor enable us to develop optimal production processes for all types of viruses in high cell density at low volumes and compact footprint. The Scale-X bioreactor also offers a straightforward scale-up based on linear velocities and eliminates the need of auxiliary unit operation for intense external concentration or perfusion devices.  To be able to serve all clients, we also offer STR process development when a scalable suspension cell upstream process is more appropriate. 

Q: How are in-house developed technologies at Exothera advancing the field of viral vector production?

Cédric Volanti: Exothera’s innovation department, led by our CTO Hanna Lesch, is constantly exploring, and evaluating new technologies when it comes to viral vector and mRNA production. We collaborate with industrial and academic partners to develop new concepts and technologies. Our Process Development and Analytical Science groups, supported by CMC and industrialization teams, ensure that those innovations can be applied for cGMP industrial manufacturing. More recently, we launched our Exoready platform that addresses several key challenges in vectors production, including predictivity and recovery, purity of product, and process scalability, with an end goal of reducing time to clinic and COGS for our clients.

Q: What technologies are used in Exothera’s facilities to streamline process scale-up from lab to commercial production?

Cédric Volanti: The most critical success factor is unambiguously the talent and experience of our people. We give the utmost attention to attracting talented scientists and experts internationally. Our teams leverage DoE, AI, and wet lab experiments to tailor the production process and analytics to the needs of our customers. We are working with the right-first-time mentality, which means that the process is built based on a thorough understanding of the process steps, volume-dependent parameters, and scalable equipment. The “one fits all” concept presents significant limitations, and the know-how of our scientists associated with state-of-the-art technologies allows fine-tuning the process (upstream and downstream) to provide our customers with the most optimized process for their application.

Q: How will Exothera expand its service offerings to meet the increasing demand for cell and gene therapies and in what ways are you ensuring that Exothera stays ahead of the curve in biopharmaceutical manufacturing technologies?

Cédric Volanti: Exothera has built a flexible technology platform to be able to serve all kinds of viral vector or mRNA clients and adapt it fast if needed. For us, it has always been critical to follow up the field and stay in a pioneer position to tackle the biopharmaceutical manufacturing challenges. This means deep scientific understanding, following up on regulatory needs, creating a culture to support innovation, and staying up to date with the latest technology developments in the field. Our goal is to ensure that our customer's programs are moving forward in the clinical phase up to commercialization flawlessly and rapidly.