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Keywords:

  • Antibody manufacturing;
  • Cell culture technology;
  • Scale-up;
  • Single-use technology;
  • Volumetric power input

Abstract

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.