A systematic and integrated use of single‐use technologies was combined with a robust monoclonal antibody platform, which led to a substantial reduction of manufacturing costs, reduced timelines and increased flexibility in clinical manufacturing. A direct scale‐up of a high titer monoclonal antibody‐expressing CHO DG44‐based cell culture platform was performed from shake flasks to a 1000 L production scale in a completely single‐use manufacturing facility. The scale‐up was done on the basis of calculating the specific volumetric power input which allowed a direct transfer from small culture volumes to the production scale. The timelines for process development were reduced to 3 months from the Research Cell Bank to the drug substance with highly optimized cells and appropriate culture conditions.
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