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High-efficiency end-to-end bioprocessing in a microfluidic bioreactor for cell and gene therapy applications

M Kalli(1) A De Grazia(1) N Naeem(1) T Phillips-Hall(1) S Loganathan(1) D Ann Carter(1) J Kusena(1) C M Cejas(1)

1:MicrofluidX Ltd, Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage SG1 2FX, United Kingdom

High-throughput cell culture processes destined for cell and gene therapy manufacturing require precise control of perfusion, harvesting efficiencies, growth rates, and other manipulation of biological cells. An essential key to this is streamlining in situ the bioprocesses involved such as seeding, transduction, expansion, perfusion, and harvest in a closed system to eliminate invasive interventions that could compromise cell viability and sterility. This can be achieved by miniaturisation of bioreactor dimensions to gain better control of the cell microenvironment in terms of media exchange and gas exchange. MicrofluidX presents a microfluidics-based bioreactor uniquely designed and focused on improving efficiency and reproducibility of cell bioprocessing, by providing a closed-system platform that can afford extreme process control, robust end-to-end process engineering and rapid process optimisation and scale-up. 

In a series of exemplar processes MicrofluidX shows the end-to-end bioprocessing capabilities of its bioreactor in relatively small volumes (0.5-12mL). The unique features and functionality generates a miniaturised environment that results in improved efficiencies for seeding, expansion, transduction, and harvesting when compared to conventional cell culture devices. Moreover, MicrofluidX shows a unique scale-up strategy based on multiplexing and parallelisation of its bioreactor, which takes advantage of the miniaturised environment of the cells while increasing cell throughput. This is achieved using a unique combination of bespoke micro-engineering and understanding of small-scale cell phenomena. With these results, MicrofluidX will bring the level of control achievable at the micro-scale to large-scale GMP production.

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