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The development of monoclonal antibody (mAb) processes conventionally involves the generation of multiple cell lines in multiwell plates, cell line screening in shake flasks followed by final cell line selection and process optimisation in bioreactors. This process can typically take up to 18 months to generate a robust process suitable for early phase manufacturing and therefore any opportunity to streamline this process impacts directly on drug development timelines.  This work describes the potential integration of the Micro-24 Bioreactor system (Pall Life Sciences) and the Duetz Microflask system (Applikon Biotechnology) into cell line development and early process development and demonstrates how these systems can be used for cell line evaluation and process optimisation. The Micro-24 Bioreactor system comprises 24 bioreactors (7ml working volume) each capable of independent temperature, dissolved oxygen and pH control. Cell cultures are carried out in a presterilised polycarbonate mammalian cell culture cassette with a central vent and are inoculated manually in a laminar flow cabinet before sealing with Type A single use closures and incubation under experimental conditions.

Use of Micro Bioreactor systems to streamline cell line evaluation and upstream process development for monoclonal antibody production