A platform for research: civil engineering, architecture and urbanism
A platform for research: civil engineering, architecture and urbanism
Fast Track API Manufacturing from Shake Flask to Production Scale Using a 1000‐L Single‐Use Facility
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.
Fast Track API Manufacturing from Shake Flask to Production Scale Using a 1000‐L Single‐Use Facility
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.
Fast Track API Manufacturing from Shake Flask to Production Scale Using a 1000‐L Single‐Use Facility
Minow, Benjamin (author) / de Witt, Hugo (author) / Knabben, Ingo (author)
Chemie Ingenieur Technik ; 85 ; 87-94
2013-02-01
8 pages
Article (Journal)
Electronic Resource
English
Innovative Membrane‐Based Fed‐Batch Shake Flask
| Wiley | 2016
| Engineering Index Backfile | 1928
| Engineering Index Backfile | 1928