Why?

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Rather than seeking to resolve the technical difficulties associated with scaling up single-use bioreactors using flexible plastic bags, Artelis has opted to increase cell density and keep volumes as small as possible.

This approach raised the following issues:

• How is it possible to achieve perfusion in a single-use plastic system? Perfusion is vital in achieving higher cell densities….
• What is the easiest way of oxygenating cultures?
• Is this approach simpler and more efficient than conventional methods?

Artelis answer

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Artelis aims to achieve this increase in density by immobilising biomass, which can be done using macroporous matrices, and combining this culture method with a single-use approach.

Artelis is looking to establish collaborations that utilize its capabilities and technologies.

Advantages

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 Single-use bioreactors with Artelis' iCELLis™ technology offer a number of advantages:

• a 20- to 100-fold reduction in volume as compared with conventional culture methods, which, together with the single-use capability, enables manufacturers to:
  • focus on developing a single culture scale: in particular, in the context of adherent cells on microbeads, no sub-passages form between beads. This in turn means a shortened development time
  • produce Phase-III clinical batches in laboratory-style facilities; a large-scale pilot facility is not required. This has a significant impact in terms of cleaning-validation and sterilisation times and on facility management. What's more, the availability of such a facility is no longer on a critical path and this can impact significantly on the supply time of clinical material
  • build simplified production facilities, which in turn means shorter validation time and lower investment- and operational costs
• the system can be used for both suspended and adherent cells with the same implementation method
• the system takes up very little space and is easy to use
• perfusion is made easier by immobilising biomass (no liquid-solid separation required)

Applications

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• viral vaccines: 10-litre scales covering the majority of human applications
• recombinant vaccines: 5-litre scales covering most applications
• monoclonal antibodies: scales of 50-100 litres covering most applications
• cell therapy: 1-litre scales covering ost applications
• academic and industrial researchers will be interested in this HCD technology for:
  • preparing small quantities of viruses
  • preparing small quantities of proteins
  • quickly setting up culture conditions