The biopharmaceutical industry has experienced unprecedented growth in recent years due to approvals for novel genomic medicines and increased need for agile, scalable vaccine production capacity to respond to emerging infectious diseases. This growth has placed tremendous pressure on virus manufacturers to increase and intensify virus production and provide industry stakeholders with superior solutions. Process intensification and integrated end-to-end continuous manufacturing are key to ensuring robust virus production with improved process economics.
Univercells Technologies has developed a high-performance upstream virus manufacturing platform optimized for viral vaccines, viral vectors, oncolytic virus, and exosome production – the NevoLine™ Upstream platform. A recently released video highlights its features, which combine the principles of process intensification and chaining of unit operations from inoculation to midstream processing, enabling the delivery of a concentrated, clarified bulk from a single system. The compact, automated module is suitable for large-scale clinical and commercial viral production.
With the NevoLine™ Upstream platform, multiple upstream unit operations are combined into a single 3 m² (32 sq ft) module, drastically reducing equipment footprint and enabling flexible cleanroom usage compared to a traditional setup with equivalent technologies (~10 m2 or 108 sq ft). The integrated design allows product concentration and diafiltration steps to be combined in batch or continuous mode with single or multi-step clarification. The platform provides robust end-to-end upstream and midstream processing with high productivity while greatly reducing operational costs to support commercial production. Other key benefits include:
- Flexibility: configurable single-use assemblies allow for process-specific combinations to suit the processing needs of different viral products with both adherent and suspension cell cultures
- Scalability: the scale-X™ nitro bioreactor is the centerpiece of the platform—a single-use structured fixed bed bioreactor available in 200 m² and 600 m² growth surface area (the latter equivalent to a ~1500 L stirred tank bioreactor). Importantly, representative scale-down models (the scale-X hydro and carbo bioreactors) are available for process development and production at pilot scale, enabling seamless and accelerated commercial translation.
- Reliability: automated operation and monitoring through a central interface delivers consistency and reproducibility while meeting regulatory requirements of traceability.
Designed by virus manufacturing experts, the NevoLine™ Upstream platform provides gene therapy innovators, vaccine developers, and CDMOs with a streamlined and flexible solution for cost-effective automated clinical and commercial-scale virus production.
For more information on the NevoLine Upstream platform, visit: https://www.univercellstech.com/products/nevoline-upstream/