Sanofi’s next-generation integrated continuous biomanufacturing platform affords numerous advantages over both legacy perfusion processes and traditional fed-batch systems. Process intensification steps allow robust operation up to 100 million cells/mL at low cell-specific perfusion rates. True continuous and integrated upstream and downstream operations permit steady-state operation, productivity, and product quality.<br/><br/>This presentation will describe a root-cause investigation that occurred after a bioreactor operating in Sanofi’s integrated continuous platform experienced an unexpected decline in cellular viability. We considered factors such as raw materials, consumables, and operational changes. A combination of bench-scale and large-scale reactors were used to study key conditions. These experiments revealed that a poor medium lot was responsible for the earlier drop in viability.<br/><br/>We have used these results to design further cell culture experiments that have identified process improvements to protect against raw material variability, ensure process stability, and optimize cell culture health. The improved process has also been run at manufacturing scale to confirm performance expectations. We are also simultaneously developing small-scale methods to screen new lots of media to further reduce the risk of raw material variability to our process.

Understanding and mitigating raw material variability in an intensified, integrated perfusion cell culture process

251st National Meeting (2016)

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