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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Pharmaceutical Technology spoke with Tania Pereira Chilima, Deputy CTO at Univercells Technologies about their technology and how it can be used in viral vector manufacturing, which is needed for production of some of the COVID-19 vaccine candidates.
Belgian-based Univercells developed the NevoLine sIPV system in early 2019 as its first automated, small-footprint, intensified process for Polio vaccine production (1). The platform, which integrates modules from cell culture to virus inactivation, was initially developed as part of a grant from the Bill & Melinda Gates foundation to manufacture a low-cost inactivated polio vaccine. When the company branched out the equipment and technologies offer into Univercells Technologies in May 2020 (2), one of the focuses was delivering the next-generation NevoLine Upstream platform, based on the same concepts, for manufacturing of viral vaccines, gene therapies, and oncolytic viruses. Pharmaceutical Technology spoke with Tania Pereira Chilima, Deputy CTO at Univercells Technologies about their technology and how it can be used in viral vector manufacturing, which is needed for production of some of the COVID-19 vaccine candidates.
PharmTech: What are the current needs in viral vector manufacturing?
Pereira Chilima (Univercells Technologies): Viral vector manufacturers face several challenges. These include establishing platform processes using existing technologies, as different products have different dose sizes and relate to different incidence rates of the disease. Hence, annual throughputs can vary by >100-fold for different indications, making it challenging to select a ‘one-size-fits-all’ system. Moreover, scalability and complexity of process development is also a challenge today, as for the highest dose applications, current technologies will struggle to support cost-effective manufacturing solutions.
We have scoped out these challenges and developed a system that addresses them by designing the scale-X bioreactor range for linear scale-up from an R&D scale to commercial scale in the NevoLine Upstream biomanufacturing platform. Moreover, the structured fixed-bed design has shown to enable significant increase in productivity in comparison with competing technologies, enabling significant costs reductions during process development and commercial manufacture.
PharmTech: What are some of the benefits and challenges of intensification?
Pereira Chilima (Univercells Technologies): Process intensification has shown significant benefits in bioprocessing. Perhaps some of the more important benefits of this approach include increases in productivity and reductions in footprint leading to reductions in CAPEX [capital expenditures] and finally cost of goods. An example of how this intensification is achieved in the NevoLine Upstream platform is our high cell density structured scale-X fixed-bed bioreactor, which is the centerpiece of the NevoLine Upstream system. Intensification was applied in the design of this system, as the biomass is immobilized in the structured fixed-bed while the cell culture media is perfused/recirculated in and out of the bioreactor. This [design] enables very high cell densities to be reached, reducing the size of the bioreactors as well as footprint and easing operations. Moreover, the benefits of process intensification are maximized if this principle is coupled with automation and chaining. The combination of these principles will enable automated parallelization of unit operations to further reduce costs, footprint, CAPEX, and process risks through reductions of manual interventions.