What is the scale-X™ nitro bioreactor ?

It is a large scale structured fixed-bed bioreactor for commercial-scale production offering?a compact size with 200 m² or 600 m² surface for growth of both suspension and adherent cells. 

How different is it from other types of bioreactors ? 

The structured fixed-bed design provides many advantages:

• It ensures an homogeneous cell distribution both through time and between batches for both suspension and adherent cells.
• It provides a low shear environment, promoting cell growth and increasing specific cell productivity (2 to 4 folds demonstrated so far).
• It enables a linear scale-up from proof-of-concept studies to commercial scale production.
• Cells can be harvested from the fixed-bed with the scale-X cell collect, allowing fixed-bed to fixed-bed seeding.
• Finally, it provides a high surface area packed into small bioreactor volume, and therefore reduces the process volume and cleanroom footprint required for production and increased productivity. 

Is it suitable for GMP compliant production ? 

Yes, the scale-X nitro bioreactor is supplied ready-to-use, gamma irradiated, with a full validation guide supporting use in GMP conditions. The NevoLine™ Upstream platform, which operates the scale-X nitro integrated with in-line clarification and concentration, also enables full compliance to 21CFR part 11. 

The scale-X technology is increasingly used for production of clinical material under GMP conditions following both FDA & EMA authority.  

What kind of applications is it suited for ? 

It has been used to produce different types of viral vectors for gene therapy (LVV, AAV, AdV), traditional viral vaccines (Measles, Rubella, sIPV and nOPV), various recombinant vaccines (based on VSV constructs), oncolytic viruses (VSV, HSV, MVA) and other applications such as exosomes and recombinant proteins.  

What cell lines grow in the scale-X nitro bioreactor ? 

The scale-X nitro is suitable for suspension and adherent cell lines. Growing suspension cells in the scale-X offers several advantages: increased cell-specific productivity, no need for serum, linear scale-up and simpler seed train It has been successfully used to date amongst others with the following: HEK293 (suspension and adherent), Vero, MRC-5, CHO, MSCs, MBDK, CEF and WI-38.  

How is it operated ?

In the integrated NevoLine™ Upstream platform which is a 4 in 1 equipment including configurable midstream processing (clarification and concentration). This compact platform is 30% smaller than traditional equipment and drives down capital and operational expenditures. Clarification I, II and concentration modules can be combined, configured, and customized based on process needs, enabling this platform solution to be used with a large variety of applications. 

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