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Fast Track API Manufacturing from Shake Flask to Production Scale Using a 1000‐L Single‐Use Facility
Author(s) -
Minow Benjamin,
de Witt Hugo,
Knabben Ingo
Publication year - 2013
Publication title -
chemie ingenieur technik
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.365
H-Index - 36
eISSN - 1522-2640
pISSN - 0009-286X
DOI - 10.1002/cite.201200136
Subject(s) - timeline , process engineering , scale (ratio) , scale up , flexibility (engineering) , process development , production (economics) , computer science , environmental science , biochemical engineering , engineering , mathematics , physics , quantum mechanics , economics , macroeconomics , statistics , classical mechanics
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.