Univercells has designed a manufacturing platform integrated, into low-footprint modules, the NevoLine™ system, that delivers upstream, downstream and concentration steps in one platform, allowing for commercial scale manufacturing to be carried out using a benchtop setup, according to the company.
“It combines the principles of process intensification, automation and chaining to miniaturize all the unit operations required for ‘end-to-end’ drug substance manufacture,” says Tania Pereira Chilima, product manager. “The result is a notable reduction in Capex and COG while magnifying the annual throughput, as more manufacturing units can be fitted within the same perimeter.”
The company offers the scale-X™ bioreactor portfolio that can be used as a standalone technology or integrated into the NevoLine platform for the upstream production step of vaccines and viral vectors for gene therapy. They are all based on the same design and can therefore be best applied for different scales of a process. The structured fixed-bed dimensions vary in height and width, offering scalability by design, continues Pereira Chilima. For example, the scale-X nitro bioreactor (200 – 600 m²) can be used as part of the NevoLine platform for clinical and commercial manufacturing, while the scale-X hydro (2.4 m²) and carbo (10 – 30m²) bioreactors offer benchtop scale-down models for process development and clinical production.
The company believes that as many “branded biologics” reach their patent expiration dates there will be more and more biosimilar products available for production. Since they are expected to be priced substantially lower than their branded counterparts, they will generate dramatic significant savings that can be passed on to healthcare authorities. Deloitte has estimated that the advent of biosimilar products would result in cost savings of $40-250 billion over the next 10 years in the US alone.
Pereira Chilima stresses that “It is important that companies looking to develop biosimilar products look to technological innovations to supply them at a competitive price while maintaining satisfactory margins. We are thoroughly committed to catalyzing the availability of biosimilars by providing manufacturing solutions which dramatically reduce COG.”
An example of an approach with dramatic cost savings potential is the company’s Adalimumab biosimilar production program, which is built on Univercells’ second manufacturing platform, a turnkey solution that can remove the barriers to local supply of biosimilars. This approach advances an option for prospective manufacturers with the key tools required to become autonomous biologics producers, according to Pereira Chilima. The package includes low footprint equipment for “end to end” bulk substance production with full documentation dossiers, including a clinical and regulatory package, process and equipment documentation, and biological materials such as GMP-grade cell lines.
