This high-performance, low-footprint upstream manufacturing platform is suitable for multiple viral applications to support the booming gene therapy market and offer a cost-effective tool for rapid response to emerging infectious diseases.
The design aims to revolutionize upstream processing by intensifying and chaining all unit operations from inoculation to midstream processing to deliver a concentrated, clarified bulk. With the NevoLine Upstream platform, commercial scale upstream production is possible in a 3 m² module, a 3-fold reduction in equipment footprint compared to conventional technologies.
The NevoLine Upstream platform was designed by virus manufacturing experts to address the needs of gene therapy and vaccine innovators and CDMOs for robust and cost-effective upstream viral vectors manufacturing. It builds on the successful proof of concept with the first NevoLine biomanufacturing platform which was specially designed for affordable production of a trivalent Sabin Inactivated Polio Vaccine (sIPV). In application, the original NevoLine sIPV platform demonstrated how the chaining of unit operations could intensify processes for drastic footprint and cost reductions, with the ability to deliver over 500,000 doses per batch below 0.30 EUR/dose, within a 10 m² equipment footprint.
The NevoLine Upstream platform accommodates all unit operations from inoculation to midstream processing within a compact module and is suited for GMP, clinical and commercial manufacturing of vaccines, gene therapies and oncolytic viruses. The automated platform offers a flexible solution suited for multiple viral applications by combining single-use assemblies in process-specific configurations. At the core of the platform is the scale-X nitro structured fixed-bed bioreactor, providing up to 600 m² of growth surface. Mammalian cell culture and virus production can be combined with concentration and single or multi-step clarification for intensified and continuous processes that deliver high productivity with drastically reduced operational costs.