A cell banking process for the provision of cryo-preserved, “Assay-Ready” cells for drug discovery programmes.
Cryopreserved “Assay Ready” cells are increasingly used in cell based assays employed in drug discovery. The convenience imparted by advance cryopreservation of all cells required in a screening programme permits the decoupling of extensive cell culture from the assay and also helps guarantee reproducibility throughout the assay programme. This allows the scientist to consider the cells as an off-the-shelf reagent. However, in the case of a genetically modified and cloned cell line – for example a cell line over-expressing a GPCR target - the genetic recombination process can alter the metabolic and physical cultivation requirements of the cell line compared with those of the unmodified host. Recombinant cell lines that are used in biopharmaceutical production are subject to extensive cell line evaluation and process development before they can be cultured at large scale.
Here we demonstrate how some of the principles of industrial process development can be applied to the supply of an “Assay Ready” recombinant CHO cell line expressing a GPCR receptor. We show how live cell imaging, cell growth curves and metabolite analysis can be used to optimise cultivation conditions and devise a scale-up strategy. Cell line growth strategy and its outputs were verified by qualitative and quantitative plating assessment and functional verification by the client. This familiarisation stage was then followed by a pilot that modelled growth and cryopreservation at scale. Once this pilot had been fully assessed, full production at scale was implemented. Data is presented to show how the culture conditions were optimised, the cell production strategy itself and how cells performed in Calcium Flux and HTRF cAMP assays as compared to client-prepared cells.
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