Eine Plattform für die Wissenschaft: Bauingenieurwesen, Architektur und Urbanistik
Eine Plattform für die Wissenschaft: Bauingenieurwesen, Architektur und Urbanistik
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 (Autor:in) / de Witt, Hugo (Autor:in) / Knabben, Ingo (Autor:in)
Chemie Ingenieur Technik ; 85 ; 87-94
01.02.2013
8 pages
Aufsatz (Zeitschrift)
Elektronische Ressource
Englisch
Innovative Membrane‐Based Fed‐Batch Shake Flask
| Wiley | 2016
| Engineering Index Backfile | 1928