The feasibility study is focusing on Modified Vaccinia Ankara (MVA) virus as an initial example of IDT’s vector technologies: given that the MVA virus already has a long history of use in clinical trials.
IDT Biologika is a CDMO specialized in vaccines, gene and immune therapy and oncolytic viruses based in Germany. Univercells company Exothera, which is based in Belgium, is a CDMO specializing in the industrialization of vaccine and gene therapy processes.
Exothera has successfully transferred IDT Biologika’s upstream process from small to large scale in the NevoLine Upstream platform from Univercells Technologies.
The NevoLine platform incorporates the ‘scale-X’ structured fixed-bed bioreactor system which offers a range of scalable options to smoothly scale viral production from R&D to commercialization. This biomanufacturing tech will help to deliver ‘cost-effective viral production that is unmatched in the industry’, according to the company.
The collaboration between IDT and Exothera will demonstrate the performance of the NevoLine platform at full commercial capacity.
"The transfer of the process from documentation receipt to input into the NevoLine Upstream Platform run has been successfully completed. The platform is now optimized for large-scale manufacturing of viral vaccines," Romain De Rauville, VP of business development at Exothera, told this publication.
"The scale-X bioreactor portfolio features high-cell-density single-use bioreactors from R&D to commercial scale, designed to simplify production processes and enhance cost-efficiency. The bioreactor is based on a compact and structured fixed-bed technology improving the homogeneous growth of adherent and suspension cells.
"The scale-X can replace hundreds of cell factories in only one run within this small footprint. The single use, closed system also offers safety benefits in the product and the handling of various viral vector manufacturing process. An automated user interface allows better process control, which improves the reproducibility of each manufacturing process."
Viral vector vaccines: COVID-19 and beyond
Viral vector vaccines have pushed the technology to the forefront: but the tech has been important for a number of programs in the past, and IDT Biologika already has a 'strong track record' in developing vaccine candidates.
"Our industry has endeavored to address more of the health concerns across the globe with innovative solutions. And as we continue to live in a COVID world, we now see vaccines are getting more attention than ever before," noted De Rauville.
"Exothera was established to be a leading cell and gene therapy-focused contract development and manufacturing organization (CDMO) by leveraging cross-functional industry expertise into programs that help customers advance their science safer, faster, and more cost effectively. To achieve these goals, we must be collaborating with the leaders in the industry, including choosing enabling technologies that can support our clients for the long run.
"Part of our technical offer is built around the strength of the scale-X bioreactor in the NevoLine Upstream platform and scientific acumen of our partners at Univercells Technologies, along with our own in-house viral vector manufacturing expertise. This allows us to work more effectively with clients like IDT Biolgika to build flexible, reliable solutions to meet the challenges of COVID vaccine manufacturing, and whatever follows.
"We also have other projects in process that are successfully running the scale-X and NevoLine technologies to produce vaccines at an extremely low cost per dose, which will be a game-changer for patient access worldwide."