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Flexible, Scalable and Configurable Single‐Use Systems for Biopharmaceutical Research and Manufacture
Author(s) -
Szarafinski Detlev
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.201200138
Subject(s) - biopharmaceutical , process engineering , ultrafiltration (renal) , scalability , downstream processing , process (computing) , mixing (physics) , downstream (manufacturing) , process development , supply chain , upstream (networking) , bioreactor , unit operation , computer science , manufacturing engineering , biochemical engineering , engineering , chemistry , chromatography , chemical engineering , operating system , microbiology and biotechnology , business , operations management , physics , computer network , organic chemistry , quantum mechanics , marketing , biology
Single‐use (SU) components are a common standard in the biopharmaceutical industry. Mixing units for buffer and media preparation, bioreactors for cell cultivation, bags for storage of liquids etc. have meanwhile become integral SU components within many biopharmaceutical manufacturing processes. However, there is still a lack of SU systems incorporating multiple process steps into a SU system which constitutes a dedicated unit operation for research and development and production of e.g. monoclonal antibodies. The FlexAct ® approach fills this gap and has been developed to supply scalable and configurable SU systems for upstream‐ and downstream processing. Typical unit operations are, e.g., buffer and media preparation, cell harvest, virus inactivation and ultrafiltration.